Clinical trial NCT04421378
Conditions: Glioblastoma Multiforme
Keywords: nGBM rGBM GBM Temozolomide Lomustine KPT-330 XPOVIO Selinexor Newly diagnosed glioblastoma multiforme Recurrent glioblastoma multiforme Bevacizumab TTField
Sponsor: Karyopharm Therapeutics Inc
Start date: 2020-06-08; Completion date: 2023-07-03
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion) and a Phase 2 randomized efficacy exploration study and will independently evaluate 3 different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or with rGBM (Arm C).

* Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM participants with uMGMT
* Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide (TMZ) (S-TRT) in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase (mMGMT)
* Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status
* Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status
* Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in rGBM participants regardless of MGMT status

Detailed description:

Arms: arm 1: Participants with nGBM uMGMT will receive 60 to 80 milligram (mg) of selinexor oral tablet once weekly (QW) across dose level -1, 1, 2, and 3 in combination with 2 Gray (Gy) radiation therapy (RT) daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently will continue at 80 mg QW until progressive disease (PD) during adjuvant therapy period. arm 2: Participants with nGBM uMGMT will receive 75 milligram per meter square (mg/m\^2) of temozolomide oral capsule once daily (QD) in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m\^2 (started from Cycle 3) and increase to 200 mg/m\^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 cycles during adjuvant therapy period. arm 3: Participants with nGBM mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, 2b and 3a and 75 mg/m\^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg (dose level 2a) or 80 mg (dose level 2b and 3a) of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m\^2 (started from Cycle 3) and increase to 200 mg/m\^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycle 4 to 8 during adjuvant therapy period. Participants will continue selinexor weekly per dose level assigned until PD. arm 4: Participants with nGBM mMGMT will receive 75 mg/m\^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m\^2 (started from Cycle 3) and increase to 200 mg/m\^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 during adjuvant therapy period. arm 5: Participants with rGBM uMGMT or mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, and 3 and 90-110 mg/m\^2 of lomustine or 150-200 mg/m\^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle across dose level -1, 1, 2, 2a, and 3 in a 42-day cycle for all cycles. arm 6: Participants with rGBM uMGMT or mMGMT will receive 110 mg/m\^2 of lomustine or 200 mg/m\^2 of Carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle in a 42-day cycle for all cycles. arm 7: Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and 10 mg/kg of Bevacizumab intravenous (IV) infusion every 2 weeks (Q2W) in 28-day cycle for all cycles. arm 8: Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and will receive scalp application of 200 kilohertz (kHz) of transducer array ≥18 hours/day daily for each cycle in 28 day cycle for all cycles.
Interventions: intervention 1: Selinexor intervention 2: Temozolomide (TMZ) intervention 3: Lomustine (CCNU) intervention 4: Standard Fractionated Radiation therapy (RT) intervention 5: Bevacizumab intervention 6: TTField intervention 7: Carmustine
Intervention descriptions: intervention 1: Dose and Formulation: 20 milligram (mg); Tablet Route of Administration: Oral intervention 2: Dose strength and Formulation: 5, 20, 100, 140, 180, or 250 mg; Capsule Route of Administration: Oral intervention 3: Dose and Formulation: 10, 40, or 100 mg; Capsule Route of Administration: Oral intervention 4: Radiation Therapy Oncology Group (RTOG) or European Organisation for Research and Treatment of Cancer (EORTC) methodologies of approximately 60 Gy in 30 fractions. intervention 5: Dose and Formulation: 10 mg/kg; Route of Administration: Intravenous intervention 6: Dose and Formulation: 200 kHz ≥18h/day; Route of administration: Scalp application of transducer arrays. intervention 7: Dose and Formulation: 150 or 200 mg/m\^2; Route of Administration: Intravenous

Protocol documents:
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Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
7 
TABLES INCLUDED IN THE TEXT 
Table 1-1  
Dose Escalation Rules ..................................................................................................... 13 
Table 2-1  
Visit Windows for Clinical Laboratory Tests (for Arm A and Arm B) .......................... 26 
Table 2-2  
Visit Windows for Vital Signs (for Arm A, B) ............................................................... 27 
Table 2-3 
Visit Windows for Clinical Laboratory Tests (for Arm C) ............................................. 27 
Table 2-4 
Visit Windows for Vital Signs (for Arm C) .................................................................... 28 
Table 2-5   
Visit Windows for Clinical Laboratory Tests (for Arm D and Arm E) .......................... 28 
Table 2-6 
Visit Windows for Vital Signs (for Arm D and Arm E) ................................................. 29 
Table 4-1  
Outcome and Censoring Definition for DOR and PFS ................................................... 36 
Table 4-2  
Outcome and censoring definition for TTP ..................................................................... 37 
 
 
  


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
8 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
Abbreviation  
Definition 
AE 
Adverse event 
BSA 
Body surface area 
C1D1 
Cycle 1 day 1 
CI 
Confidence interval 
CR 
Complete response 
CRF 
Case report form 
CT 
Computerized tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CxDx (e.g., C1D1) 
Cycle x Day x (e.g., Cycle 1 Day 1) 
DCR 
Disease control rate 
DLT 
Dose-limiting toxicity 
DOR 
Duration of response 
DSMB 
Data Safety Monitoring Board 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EoT 
End of Treatment 
EDC 
Electronic data capture 
EOT 
End of Treatment 
GBM  
Glioblastoma multiforme 
HR 
Hazard ratio 
ICF 
Informed consent form 
IRC 
Independent Review Committee 
K-M 
Kaplan-Meier 
KPS 
Karnofsky Performance Score 
MedDRA 
Medical Dictionary for Regulatory Activities 
MGMT  
O6-methylguanine-DNA-methyltransferase 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
9 
Abbreviation  
Definition 
mITT 
Modified intent-to-treat 
mMGMT 
Methylated O6-methylguanine-DNA-methyltransferase 
uMGMT 
Unmethylated O6-methylguanine-DNA-methyltransferase 
MRI 
Magnetic resonance imaging 
MTD 
Maximum tolerated dose 
NCI 
National Cancer Institute 
NE 
Not evaluable 
nGBM 
Newly diagnosed GBM patients 
ORR 
Overall response rate 
OS 
Overall survival 
PD 
Progressive disease 
PDn 
Pharmacodynamic 
PFS 
Progression-free survival 
PFS3 
Progression-free survival rate at 3 months 
PFS6 
Progression-free survival rate at 6 months 
PI 
Principal Investigator 
PK 
Pharmacokinetic 
PP 
Per-protocol 
PR 
Partial response 
PT 
Preferred term 
RT 
Radiation Therapy 
QW 
Once weekly 
QoL 
Quality of life 
rGBM 
Recurrent GBM patients 
RP2D 
Recommended phase 2 dose 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SBP 
Systolic blood pressure 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
10 
Abbreviation  
Definition 
SD 
Stable disease 
SOC 
System organ class 
SRC 
Safety Review Committee 
TEAE 
Treatment-emergent adverse event 
TTP 
Time to progression 
ULN 
Upper limit of normal 
WBC 
White blood cell 
WHO 
World health organization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
11 
1. 
OVERVIEW AND INVESTIGATIONAL PLAN 
1.1. 
STUDY DESIGN 
This is a global, multicenter, open-label, clinical study with Dose Escalation (Phase 1a) 
followed by Phase 1b (Dose Expansion) and (Phase 2 randomized efficacy exploration) 
to independently assess the MTD, efficacy, and safety of selinexor in combination with 
SoC therapy for nGBM or rGBM. The study will independently evaluate 5 different 
combination regimens in 5 treatment arms in patients with nGBM (Arms A and B) or with 
rGBM (Arm C, D, and E). 
• Arm A: evaluating the combination of selinexor with RT (S-RT) in nGBM patients 
with uMGMT 
• Arm B: evaluating the combination of selinexor with RT and TMZ (S-TRT) in 
nGBM patients with mMGMT 
• Arm C: evaluating the combination of selinexor with lomustine (or carmustine if 
lomustine is not available) (S-L/C) in rGBM patients regardless of MGMT status 
• Arm D: evaluating the combination of selinexor with bevacizumab in rGBM patients 
regardless of MGMT status 
• Arm E: evaluating the combination of selinexor with TTField in rGBM patients 
regardless of MGMT status 
An overview of all arms is provided in the Study Flow Chart (Figure 1-1).  


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
12 
Figure 1-1  
Study Flow Chart 
 
 






Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
15 
1.1.3. 
Phase 2 – Efficacy Exploration/Randomization Phase 
During Phase 2, patients will receive the RP2D in each arm in an open-label, randomized 
design. The number of patients for each arm in the Phase 2 portion will be evaluated again at the 
end of the Phase 1 portion. 
• Arm A: nGBM uMGMT approximately 108 patients (54 patients in 
S+RTexperimental arm and 54 patients in TRT control arm). 
• Arm B: nGBM mMGMT approximately 124 patients (62 patients in S+TRT 
experimental arm and 62 patients in TRT control arm). 
• Arm C: rGBM regardless of MGMT status, approximately 118 patients (59 patients 
in S+L/C experimental arm and 59 patients in L/C control arm). 
Randomization in Arm C (Section 7.2) will be stratified based on: 
• Number of prior lines of anti-GBM regimens (1 versus >1) 
It is planned to randomize patients in a 1:1 allocation to treatment and control arm. 
Patients will continue to receive treatment until disease progression (however, patients may stay 
on treatment if they have documented clinical benefit per the Investigator and after documented 
approval with the medical monitor), death, toxicity (i.e., AEs that cannot be managed with 
medical care), or withdrawal from the study. 
1.2. 
OBJECTIVES  
1.2.1. 
Primary Objective 
This is a Phase 1/2 study of selinexor in combination with SoC therapy for nGBM or rGBM. 
This study will be conducted in 2 phases. The modified RANO criteria will be used for 
assessment in Arms A, B, and D; and RANO criteria for Arms C and E. 
The specific primary objectives are as follows: 
Objectives 
Endpoints 
Primary Objectives 
Phase 1a (for all arms) 
• To assess the MTD per arm 
• To evaluate the RP2D per arm 
 
 
Primary Endpoints 
Phase 1a (for all arms) 
• MTD/RP2D per arm 
• The occurrence of Grade ≥3 AEs, all 
serious adverse events (SAEs), and all 
AEs leading to treatment 
discontinuation 
Phase 1b (for all arms) 
• To determine the efficacy of selinexor 
in all patients as determined by the 3-
month PFS (PFS3) rate with PFS 
assessment as per RANO/modified 
RANO per Investigator assessment  
Phase 1b (for all arms) 
• All Arms: PFS3 (survival probability 
of having PFS ≥3 months as estimated 
by Kaplan-Meier method per 
Investigator assessment)  


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
16 
• To determine the efficacy of selinexor 
in all patients as determined by the OS 
• OS, defined as the time from initiation 
of treatment until death due to any 
cause 
Phase 2  
• Arms A and B: to determine the 
efficacy of selinexor in all nGBM 
patients as determined by PFS per 
modified RANO per independent 
review committee (IRC) in patients 
randomized to the experimental arm 
(S-RT in Arm A and S-TRT in Arm 
B) vs the control arm treated with SoC 
regimen (TRT) in the targeted 
population 
Phase 2  
• Arms A and B: PFS, defined as the 
time from date of randomization until 
the first date of PD or death due to any 
cause per IRC assessment  
 
• Arm C: to compare OS in all rGBM 
patients randomized to the 
experimental arm (selinexor + 
lomustine/or carmustine) vs the 
control arm treated with SoC regimen 
(lomustine/carmustine) in the targeted 
population 
• Arm C: OS, defined as the time from 
randomization until death due to any 
cause 
 
1.2.2. 
Secondary Objectives 
The specific secondary objectives are as follows. The modified RANO criteria will be used for 
assessment in Arms A, B, and D; and RANO criteria for Arms C and E. 
Secondary Objectives 
Phase 1a 
• To assess OS for each arm 
independently  
Secondary Endpoints 
Phase 1a 
• OS 
Phase 1a/b  
• To assess time-to-progression (TTP) 
and PFS for each arm independently 
 
Phase 1a/b 
• TTP, defined as time from date of first 
study treatment until progression or 
death due to progression 
• PFS 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
17 
• For Arm C, D, and E only: To 
evaluate the overall response rate 
(ORR) and disease control rate (DCR) 
based on RANO/modified RANO 
criteria  
• For Arm C, D, and E only: To assess 
duration of response (DOR)  
 
• For Arm C, D, and E only: ORR, 
defined as the proportion of patients 
who have a response of partial 
response (PR) or complete response 
(CR)  
• For Arm C, D, and E only: DCR, 
defined as the proportion of patients in 
whom the best overall response is 
determined as CR, PR or stable 
disease (SD)  
• For Arm C, D, and E only: DOR, 
defined as time from date of first 
occurrence of objective response (PR 
or CR) until progression 
• To assess selinexor PK in plasma 
when administered with radiation 
therapy, temozolomide, and/or 
lomustine/ carmustine, bevacizumab, 
and TTField 
• Selinexor PK parameters (e.g., 
clearance [CL], area under the 
concentration curve [AUC], maximum 
concentration [Cmax]) 
Phase 1b 
• To obtain additional safety, 
tolerability data. 
Phase 1b 
• To further characterize the occurrence 
of Grade ≥3 AE, all serious adverse 
events (SAEs), and all AEs leading to 
treatment discontinuation and confirm 
tolerability at the MTD/RP2D. 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
18 
Phase 2 
• 
Arms A and B: to determine the efficacy 
of selinexor in all nGBM patients as 
determined by PFS per modified RANO 
criteria per investigator assessment in 
patients randomized to the experimental 
arm vs the control arm treated with SoC 
regimen in the targeted population 
• Arms A and B: to compare OS in all 
nGBM patients randomized to the 
experimental arm vs the control arm 
treated with SoC regimen in the 
targeted population 
• 
Arm C: to determine PFS per RANO 
criteria per IRC and investigator 
assessment in all rGBM patients 
randomized to the experimental arm vs 
the control arm treated with SoC regimen 
in the targeted population. 
• 
Arm C only: to compare the ORR and 
DCR based on the response per RANO 
per Investigator assessment and per IRC 
in patients randomized to the 
experimental arm vs the control arm 
treated with SoC regimen in the targeted 
population. 
• 
Arm C only: to compare the DOR per 
RANO per Investigator assessment and 
per IRC in patients randomized to the 
experimental arm vs the control arm 
• 
All Arms: to determine the efficacy of 
selinexor in all patients as determined by 
the (PFS6) rate where PFS assessment is 
per RANO/modified RANO per IRC and 
investigator assessment   
• 
All Arms: to assess the 1 and 2-year OS 
rate of patients in experimental and 
control arm 
• 
All Arms: to assess the safety and 
tolerability of treatment in patients 
randomized to the experimental arm vs 
Phase 2 
• 
Arms A and B: PFS per Investigator 
assessment 
• 
Arms A and B: OS for patients with 
nGBM 
• 
Arm C: PFS per IRC assessment 
• 
Arm C: PFS per Investigator 
assessment 
• 
Arm C only: ORR per IRC and 
Investigator assessment 
• 
Arm C only: DCR per IRC and 
Investigator assessment 
• 
Arm C only: DOR per IRC and 
Investigator assessment 
• 
All Arms: PFS6 (survival probability of 
having PFS ≥ 6 months as estimated by 
Kaplan-Meier method per IRC and 
investigator assessment) 
• 
All Arms: 1-year OS (OS1) and 2-year 
OS (OS2) rate as estimated by 
Kaplan-Meier method 
• 
All Arms: Safety 
• 
All Arms: Incidence of selected Grade 
≥3 AEs, including hematological 
abnormalities, gastrointestinal disorders 
(nausea, vomiting, and diarrhea), and 
fatigue 
• 
All Arms: Incidence of all SAEs. 
• 
All Arms: Incidence of AEs leading to 
treatment discontinuation 
 


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Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
23 
• Follow-up period: After discontinuation of study treatment, patients will be followed for 
safety up to 30 days after last dose, for PFS approximately every 3 months after end of 
treatment visit until PD, death or initiation of the subsequent anti-GBM treatment (if a 
patient discontinues from the treatment due to reasons other than PD), and for survival 
every 3 months after end of treatment visit until the end of study (i.e., when the last 
patient in the study has been followed on study treatment for at least 1 year or completed 
at least 6 months of survival follow-up period after their last dose of study treatment, has 
withdrawn consent, has died, or has been lost to follow-up, whichever occurs first). 
• End of study: will occur after the last patient to be enrolled has been followed on study 
treatment for at least 1 year or completed the at least 6 months of survival follow-up 
period.   
1.5. 
MODIFICATIONS TO THE STATISTICAL SECTION OF THE 
PROTOCOL 
Not applicable. The current SAP is based on Protocol v6.0. 
1.6. 
CHANGES IN THE STATISTICAL ANALYSIS PLAN 
Not applicable. This is the original version of the SAP. 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
24 
2. 
GENERAL STATISTICAL METHODS AND DATA HANDLING 
This SAP outlines the methods to be used in the analysis of clinical data in order to answer the 
study objectives. Populations for analysis, data handling rules, and statistical methods are 
provided. This SAP does not include endpoints and methods to be used in the analysis of PK 
and PDn data; these will be included in a separate plan. This version of SAP is mainly to specify 
analyses for Phase 1a/b and more details of analyses for Phase 2 will be provided in later 
versions.  
2.1. 
GENERAL ANALYSIS METHODS 
All summary statistics will be computed and displayed among the corresponding analysis 
population, and by each assessment time point whenever applicable. Summary statistics for 
continuous variables will in general include n, median, mean, standard deviation, minimum, and 
maximum. For categorical variables, frequencies and percentages will be presented with the 
denominators for the percentages determined based on the analysis population used, unless 
otherwise specified. For time-to-event variables, the Kaplan-Meier (KM) method will be used 
for descriptive summaries. Graphical displays may be provided as appropriate.  
2.2. 
OBSERVATION PERIOD 
The observation period will be divided by the following: 
• The pre-treatment period is defined as the time from the signed informed consent date up 
to the time before the first dose of study treatment 
• The treatment period is defined as the time from the first dose of study treatment up to 
the date of last study treatment + 30 days, or the day before initiation of a new anti-
neoplastic treatment, whichever comes first, inclusive 
• The post-treatment period is defined as the time beyond the treatment period 
The on-study observation period is the pre-treatment, treatment, and post-treatment period. 
2.3. 
MISSING DATA HANDLING IN DATA PRESENTATION 
In general, missing baseline values will not be imputed. The following approaches are default 
methods for missing data handling in summary tables. 
• Categorical data will be summarized using counts (n) and percentages (%). The 
denominator will be the total number of people in the corresponding analysis group, 
based on the population specified for the summary, unless otherwise specified. Missing 
data may be presented as a separate category. 
• Continuous data: summaries will be based on observed data only 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
25 
2.3.1. 
Handling of Computation of Treatment Duration if Study Treatment End of 
Treatment Date is Missing 
For the calculation of treatment duration, the date of the last dose of study treatment is equal to 
the date of last study treatment dosing reported on the electronic case report form (eCRF) dosing 
page. If all the dosing dates are missing, then the duration is missing. 
2.3.2. 
Handling of Missing/partial Dates for Adverse Events or Concomitant 
Medications 
In general, the imputation should be conservative such that onset dates should be imputed to be 
as early as possible and resolution dates as late as possible. However, for categorization 
purposes, if the partial AE onset date information does not indicate whether the AE started prior 
to treatment, during the treatment period, or after the treatment period, the AE will be classified 
as treatment-emergent.  
The data imputations are only for categorization purposes or calculation of AE duration, and 
will not be used in listings. 
Refer to the Karyopharm Biostatistics and Statistical Programming Rule Book Version 2.0 for 
details on imputation methods. 
2.3.3. 
Handling of Missing Assessment of Relationship of AEs to Study Treatment 
If the assessment of the relationship to study treatment is missing, then the relationship to study 
treatment is considered as related. 
2.4. 
STUDY TREATMENT DOSING DATE 
Study treatment dosing date is the date on which a patient actually received study treatment 
(partial or complete), as recorded on the study drug exposure eCRF. 
The start date of study treatment is defined as the earliest non-zero dose date of any study drug, 
and the end date of study treatment is defined as the latest non-zero dose date of any study drug.  
2.5. 
STUDY DAY CALCULATION 
Study Day 1 is the date of first study treatment. The day before Day 1 is considered Day -1. 
There is no Day 0. 
A patient is considered as treated in a cycle if the patient received any non-zero dose of study 
drug in that cycle. 
Study day for a given assessment is defined as 
• the assessment date – the date of first study treatment + 1 if the assessment date is on or 
after Day 1, or 
• The assessment date – the date of first study treatment if the assessment date is before 
Day 1 










Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
30 
Table, listing, and figure production 
SAS Version 9.4 or higher 
Coding 
 
AEs 
MedDRA Version 24.0 or higher 
Medical Histories 
MedDRA Version 24.0 or higher 
Prior and Concomitant Medications 
WHO DDE Version September 2018 or 
higher 
Grading 
 
AEs 
CTCAE Version 4.03 
Labs 
CTCAE Version 4.03 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
31 
3. 
PATIENT INFORMATION 
3.1. 
ANALYSIS POPULATIONS 
Dose Escalation Population (per Arm in Phase 1a) 
The dose escalation population will consist of all patients in the Dose Escalation Phase 1a who 
have either had a DLT prior to completion of 1 cycle of therapy, or who have completed a cycle 
of therapy. 
RP2D Population (per Arm in Phase 1a/b) 
The RP2D population will consist of all patients in the Dose Expansion Phase 1b and those in 
Phase 1a receiving RP2D dose who receive at least 1 dose of study treatment.  
mITT Population (per Arm in Phase 1a/b) 
The mITT population will consist of patients in Phase 1a and Phase 1b who have been assigned 
to study intervention and who have received ≥1 dose of study drug.  
Safety Population (per Arm in Phase 1a/b) 
The safety population will consist of patients in Phase 1a and Phase 1b who have been assigned 
to study intervention and who have received ≥1 dose of study drug. Participants will be 
analyzed according to the intervention actually received. 
3.2. 
DISPOSITION OF PATIENTS 
The following variables may be used to summarize patient disposition: 
• Patients who received at least one dose of study treatment (partial or complete) 
• End of treatment status: 
o Patients still on treatment (if applicable) 
o Patients who discontinued treatment and primary reason for treatment 
discontinuation 
• Survival follow-up status 
o Patients in survival follow-up 
o Patients who have completed 1-year survival follow-up 
o Patients who died during survival follow-up 
o Patients who discontinued from the study without completing 1-year survival 
follow-up 
• End of study status: 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
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o Patients still on study (if applicable) 
o Patients who discontinued study and primary reason for study discontinuation 
The number of patients in each analysis population will be presented. 
3.3. 
PROTOCOL DEVIATIONS 
Major protocol deviations will be presented in a listing.  
3.4. 
DEMOGRAPHICS, MEDICAL HISTORY AND BASELINE 
CHARACTERISTICS 
Demographics, medical history and baseline characteristics will generally be summarized 
among dose escalation Population, RP2D Population and safety populations, unless otherwise 
specified. 
3.4.1. 
Demographic Data 
The demographic characteristics to be summarized will include gender, race, ethnicity (Hispanic 
origin), and age at time of consent. For gender, race, and Hispanic origin, the summary statistics 
will be the number and percentage of patients within each category. The categories for race will 
be those recorded in the database. For age at time of consent, the mean, median, minimum, 
maximum, and standard deviation will be provided for each group and the total sample. 
3.4.2. 
Prior Treatment 
There are 3 types of prior treatments for GBM: radiation therapy, antineoplastic therapy and 
surgery.  Number and percentage of prior radiation therapy, prior antineoplastic therapy, and 
prior surgery will be summarized. 
3.4.3. 
Medical History - Conditions and Procedures 
Medical history other than GBM will be summarized by system organ class (SOC) and 
preferred term (PT) using the number and percentage of patients who have at least one 
occurrence of a SOC and PT.  
Medical history information may also be provided in a data listing. 
3.4.4. 
Disease History 
The following summary statistics will be summarized using descriptive statistics:  
• Number and percentage of initial diagnosis 
• Time since initial diagnosis to first recurrence/relapse 
• Time since initial diagnosis to most recent recurrence/relapse 
• Time since initial diagnosis to informed consent 
• Time since most recent recurrent/relapse to informed consent  


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
33 
3.5. 
PRIOR AND CONCOMITANT MEDICATIONS 
All medications will be coded using the World Health Organization Drug Dictionary Enhanced 
(WHO DDE).  
Prior medications are any medications received by the patient prior to the first dose of study 
drug. Prior medications can be discontinued before the first dose of study treatment or can be 
ongoing during treatment period. 
Concomitant medications are any treatments received by the patient concomitantly with study 
treatment, from first dose of study treatment to last dose of study treatment + 30 days.  
Note that a medication can be classified as both a prior medication and a concomitant 
medication. 
Concomitant medications will generally be summarized among mITT and safety populations, 
unless otherwise specified. Concomitant medications will be summarized according to the 
WHO DDE by the ATC level 2 (therapeutic level), level 4 (generic level) and preferred name. A 
patient taking the same drug multiple times will only be counted once.  
The use of prior and concomitant medications and procedures may also be provided in a data 
listing. 
Please refer to Section 2.3.2 for details on data handling rules related to computation, dates and 
imputation for missing dates. 
3.6. 
EXTENT OF STUDY TREATMENT EXPOSURE AND COMPLIANCE 
Extent of exposure and compliance will be summarized for dose escalation population, RP2D 
population and safety populations, unless otherwise specified. 
3.6.1. 
Extent of Study Treatment Exposure 
The extent of exposure for the study treatment will be assessed using the following variables: 
• Duration of study treatment exposure (continuous and categorized) 
• Occurrence of selinexor dose escalation 
The following will be assessed separately for each study drug (selinexor, Temozolomide, 
Lomustine and etc.): 
• Duration of exposure (continuous and categorized) 
• Total dose received (continuous) 
• Average dose received per week (continuous) 
• Occurrence of dose reduction 
• Occurrence of dose interruption 
• Occurrence of missed dose 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
34 
Duration of study treatment exposure is defined as the date of last study treatment – date of first 
study treatment + 1. 
Average dose received per week is defined as total dose received divided by duration of 
exposure. 
3.6.2. 
Treatment Compliance 
Study treatment compliance is defined as 
number of actual study treatment doses taken
number of  study treatment doses prescribed × 100 
A study treatment dose is considered prescribed if any study drug is prescribed. The number and 
percentage of patients with study treatment compliance ≥80% will be provided. Note that the 
number of prescribed study treatment doses does not include doses missed due to treatment 
interruption or other reasons not related to patient choice.  
Selinexor compliance is similarly defined as 
number of actual selinexor doses taken
number of  selinexor doses prescribed × 100 
The number of scheduled selinexor doses does not include doses missed due to treatment 
interruption or other reasons not related to patient choice. The number and percentage of 
patients with selinexor compliance ≥80% will be provided. 
Lomustine and other drug (if applicable) compliance will be defined and summarized in the 
same manner. 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
Statistical Analysis Plan: XPORT-GBM-029 
 
Version 1.0
 
 
 
 
 
35 
4. 
EFFICACY 
Objective disease response assessment will be made according to modified RANO in 
Arms A, B, D or RANO in Arms C and E. The data used for Phase 1 primary analysis will be 
based on Investigator assessment and that of Phase 2 primary statistical analysis will be 
provided by the IRC.  
Documentation of response requires two consecutive assessments of the disease, performed at 
time with 4 weeks interval required between the two assessments. The date of response or PD 
will be assigned to the earlier date of the two independent assessments, unless PD is based on an 
unambiguous criterion such as a clinical deterioration not attributable to other causes apart from 
tumor or attributable to changes in steroid dose. 
If a patient had one PD assessment but was not subsequently confirmed, unless IRC considers 
the progression assessment unambiguous, it is not considered a PD event per modified RANO. 
4.1. 
PRIMARY EFFICACY ENDPOINT 
4.1.1. 
Rate of 3-Month Progression Free Survival (PFS3) – Ph1b 
The analysis of PFS3 will be performed by calculating the estimated survival probability of 
having PFS ≥ 3 months based on Kaplan-Meier method, where PFS will be calculated from the 
date of start of study treatment to the date of progression, or date of death should progression 
not have occurred. The outcome and censoring definitions of PFS are provided in OS will be 
calculated from the date of start of study treatment to the date of death. Patients who are still 
alive prior to the data cutoff for efficacy analysis, or who dropout prior to study end, will be 
censored on the day they were last known to be alive. The analysis of OS will be based on the 
Kaplan-Meier method for estimation of summary statistics including 50th percentiles (median) 
and associated 95% CIs. 
 
 


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. 
The target day of 3-month assessment in Arm A and B is Cycle 3 Day 22 (day 92) with a 
window of ±3 days. The target day of 3-month assessment in Arm C is Cycle 2 Day 36 (day 78) 
with a window of ±3 days. The target day of 3-month assessment in Arm D and E is Cycle 3 
Day 22 (day 78) with a window of ±3 days. To accommodate potential changes in individual 
patient’s visit schedules, disease assessments on or before day 97 will be used for the primary 
analysis of rate of 3-month PFS. Actual times of events (progression or death) will be used for 
the Kaplan-Meier statistical summary of PFS.  
A sensitivity analysis of the primary endpoint of PFS3 will be performed to assess the potential 
influence of causality of deaths on study, where deaths due to causes that are clearly unrelated to 
the disease or study drug would not be considered as a PFS event and instead would be censored 
on the last response assessment before a censoring event.   
4.1.2. 
OS – Ph1b 
OS will be calculated from the date of start of study treatment to the date of death. Patients who 
are still alive prior to the data cutoff for efficacy analysis, or who dropout prior to study end, 
will be censored on the day they were last known to be alive. The analysis of OS will be based 
on the Kaplan-Meier method for estimation of summary statistics including 50th percentiles 
(median) and associated 95% CIs. 
 
 


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4.2. 
SECONDARY EFFICACY ENDPOINTS 
4.2.1. 
OS - Ph1a 
OS will be calculated similarly to that in primary endpoint.  
4.2.2. 
PFS - Ph1a/b 
PFS is defined as the duration from date of first dose until the date of first confirmed PD or 
death due to any cause on or before EOT + 30 days, whichever occurs first. The outcome and 
censoring definitions are provided in OS will be calculated from the date of start of study 
treatment to the date of death. Patients who are still alive prior to the data cutoff for efficacy 
analysis, or who dropout prior to study end, will be censored on the day they were last known to 
be alive. The analysis of OS will be based on the Kaplan-Meier method for estimation of 
summary statistics including 50th percentiles (median) and associated 95% CIs. 
 
 


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.  
If a patient has preliminary PD without a confirmed PD per mRANO, and has EOT due to 
clinical PD, then EOT is treated as confirmed PD.  
The number and percentage of censored patients will be reported. The 25th, 50th (median), and 
75th percentiles for PFS and associated 95% CIs will be estimated based on the K-M method, 
and the K-M curves will be provided.  
Table 4-1  
Outcome and Censoring Definition for DOR and PFS 
Situation 
Date of event or censoring 
Outcome 
No adequate post-baseline disease status 
assessment unless death occurs prior to 
first post-baseline assessment  
Date of first dose 
Censored 
Death before PD without a gap of 2 or 
more consecutively missed scheduled 
disease status assessments before death 
Date of death 
Event 
Confirmed PD without a gap of 2 or 
more consecutively missed scheduled 
disease status assessment before 
progression 
Date of PD (first preliminary PD 
per Modified RANO) 
Event 
No confirmed PD or death on or before  
a. database cut,  
b. withdrawal of informed consent, 
c. lost to follow-up,  
d. start of new GBM treatment,  
whichever occurs first 
Date of last adequate disease 
assessment prior to the earliest 
occurrence of the events (a. – d.) 
listed in the left column 
Censored 
No confirmed PD or death before a gap 
of 2 or more consecutively missed 
scheduled disease status assessment  
Date of last adequate disease 
assessment prior to the gap 
Censored 
 


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4.2.3. 
TTP - Ph1a/b for Arm C, D and E only 
TTP is defined as the duration from start of study treatment to time of PD or death due to 
disease progression, whichever occurs first. Details on the outcome and censoring definitions 
are provided in Table 4-2. 
The number and percentage of censored patients will be reported. The median TTP and 
associated 95% CI will be estimated based on the K-M method, and the K-M curve will be 
provided. 
Table 4-2  
Outcome and censoring definition for TTP 
Situation 
Date of event or censoring 
Outcome 
No adequate post-baseline disease status 
assessment unless death due to disease 
progression occurs prior to first post-
baseline assessment  
Date of first dose 
Censored 
Death due to disease progression before 
PD without a gap of 2 or more 
consecutively missed scheduled disease 
status assessments before death 
Date of death 
Event 
Confirmed PD without a gap of 2 or 
more consecutively missed scheduled 
disease status assessment before 
progression 
Date of PD (first preliminary PD 
per Modified RANO) 
Event 
No confirmed PD or death due to 
disease progression on or before  
a. death due to reasons other than 
disease progression,  
b. database cut,  
c. withdrawal of informed consent, 
d. lost to follow-up,  
e. start of new GBM treatment,  
whichever occurs first 
Date of last adequate disease 
assessment prior to the earliest 
occurrence of the events (a. – e.) 
listed in the left column 
Censored 


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No confirmed PD or death due to 
disease progression before a gap of 2 or 
more consecutively missed scheduled 
disease status assessment  
Date of last adequate disease 
assessment prior to the gap 
Censored 
4.2.4. 
ORR - Ph1a/b for Arm C, D and E only 
ORR is defined as either complete response (CR) or partial response (PR), calculated as a 
proportion and including a 95% exact CI.  
4.2.5. 
DCR - Ph1a/b for Arm C, D and E only 
DCR is defined as defined as the proportion of patients in whom the best overall response is 
determined as CR, PR, or stable disease (SD), calculated as a proportion and including a 95% 
exact CI. The duration of stable disease, which is calculated from C1D1 to first PD, death due to 
any cause or initiating a new anti-GBM treatment, is required no shorter than 16 weeks.  
4.2.6. 
DOR - Ph1a/b for Arm C, D and E only 
DOR is defined, for patients with a confirmed PR or better as the duration from the date of first 
confirmed PR or better to the date of first confirmed PD or death due to any cause, whichever 
occurs first. Details on the outcome and censoring definitions used for DOR are provided are 
provided in OS will be calculated from the date of start of study treatment to the date of death. 
Patients who are still alive prior to the data cutoff for efficacy analysis, or who dropout prior to 
study end, will be censored on the day they were last known to be alive. The analysis of OS will 
be based on the Kaplan-Meier method for estimation of summary statistics including 50th 
percentiles (median) and associated 95% CIs. 
 
 


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Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
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5. 
SAFETY 
Safety analyses will be based on the reported AEs and other safety information, such as ECG, 
vital signs, physical examination, Karnofsky performance status, and clinical laboratory 
assessments. Safety analyses will be performed using the safety population and will be 
descriptive; no statistical testing is planned.  
5.1. 
ADVERSE EVENTS 
An AE is defined as any untoward medical occurrence in a patient receiving a pharmaceutical 
product regardless of a causal relationship with this treatment. An AE can therefore be any 
unfavorable sign and unintended sign (including an abnormal laboratory finding), symptom, or 
disease temporally associated with the use of a study treatment, whether or not related to the 
study treatment.  
All AEs (including serious adverse events [SAEs]) will be coded to a PT and associated primary 
SOC using the Medical Dictionary for Regulatory Activities (MedDRA). 
The severity of all AEs will be graded according to the NCI CTCAE Grading Scale. An AE 
with a CTCAE grade of 3 or higher is considered a severe AE. The severity of the AE is 
different from the seriousness of the AE.  
5.1.1. 
Definitions 
• A treatment-emergent AE (TEAE) is an AE that was not present prior to the initiation 
of study treatment or was present and worsened in intensity or frequency following 
exposure to study treatment, from the first dose to 30 days after the last dose (inclusive). 
Additionally, any AE that occurs 30 days after the last dose of study treatment is 
considered a TEAE if considered by the Investigator as related to any study treatment.  
• A serious AE (SAE) is any untoward medical occurrence that, at any dose, results in 
death; is life threatening (i.e., an event in which the patient was at risk of death at the 
time of the event; it does not refer to an event that hypothetically might have caused 
death if it were more severe); requires inpatient hospitalization or prolongation of 
existing hospitalization; results in persistent or significant disability/incapacity; or is a 
congenital anomaly/birth defect 
• A treatment-emergent treatment-related AE (TRAE) is any TEAE that is considered by 
the Investigator to be related to any study treatment. 
5.1.2. 
Analysis Methods 
Analyses of AEs will be performed only for TEAEs. 
If an AE date/time of onset (occurrence or worsening) is incomplete, an imputation algorithm 
will be used to classify the AE is treatment-emergent. The algorithm for imputing date/time of 
onset will be conservative and will classify an AE as treatment-emergent unless there is 


Selinexor (KCP-330)                            
       
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definitive information to determine it is not treatment emergent. Details on classification of AEs 
with missing or partial onset dates are provided in Section 2.3.2. 
AE summaries will include number and percentage of patients who have experienced a TEAE. 
The denominator for percentages is the total number of patients in the treatment Arm. Multiple 
occurrences of the same event in the same patient will be counted only once in the tables. 
Unless otherwise specified, sorting order will follow the alphabetic order in SOC, and further by 
decreasing frequency of PTs within each SOC. When more than one PT has same number of 
events, the order of presentation will be alphabetical in PTs. 
The summary of AEs by causality will generally include the following categories of causality. 
• Related to any study drug 
• Related to Selinexor only  
• Related to Temozolomide only (Arm A and B)  
• Related to Lomustine only (Arm C) 
• Related to Bevacizumab only (Arm D) 
• Related to Tumor Treating Fields only (Arm E) 
• Not related to any of the above drug 
5.1.2.1. 
Analysis of TEAEs 
A TEAE overview summary table will be provided, which will include the number of patients 
with any:  
• TEAEs 
o Grade 3/4 
o Serious 
o Leading to dose modification (i.e., reduction or interruption) of any study drug 
o Leading to dose reduction of any study drug 
o Leading to dose interruption of any study drug 
o Leading to study treatment discontinuation 
o Leading to death 
• TRAEs 
o Same subcategories as for TEAEs 


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TEAEs will also be summarized by primary SOC and PT and will include the following 
categories: 
• All 
o By maximum grade 
o By causality 
• Grade ≥3 
• Leading to dose modification of any study drug 
• Leading to dose reduction of any study drug 
• Leading to dose interruption of any study drug 
• Leading to study treatment discontinuation 
5.1.2.2. 
Analysis of SAEs 
Treatment-emergent SAEs will be summarized by primary SOC and PT and will include the 
following categories: 
• All 
• Leading to dose modification of any study drug 
• Leading to dose reduction of any study drug 
• Leading to dose interruption of any study drug 
• Leading to study treatment discontinuation 
Data listings will be provided for SAEs. 
5.1.2.3. 
Analysis of DLTs 
DLTs will be summarized in the dose escalation population. A data listing will be provided for 
DLTs. 
5.2. 
DEATH 
The following summaries on death events will be provided: 
• An overview of all death events and primary cause of death 
• TEAEs leading to death (death as an outcome on the AE page as reported by the 
Investigator), by primary SOC and PT 
• TEAEs leading to death and are related to study treatment, by primary SOC and PT 
• Listing of all TEAEs leading to death 


Selinexor (KCP-330)                            
       
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• Listing of all death events 
5.3. 
LABORATORY SAFETY VARIABLES 
5.3.1. 
Definitions 
Blood samples for clinical laboratory tests will be taken as specified in the study protocol, and 
measurements in conventional units will be converted using the international system of units 
(SI).  
5.3.2. 
Analysis of Laboratory Variables 
For each dose level, the actual value and change from baseline (Day 1, prior to the first 
administration of study drug) to each on study evaluation will be summarized for each clinical 
laboratory parameter, including hematology and clinical chemistry. In the event of repeat 
values, the last non-missing value per study day/time will be used.  
Severity of select clinical lab measures will be determined using CTCAE criteria (e.g., those 
measures that have a corresponding CTCAE grade classification). Shift tables that present 
changes from baseline to worst on-study and baseline to last on-study values relative to CTCAE 
classification ranges will be produced. 
5.4. 
VITAL SIGNS, KARNOFSKY PERFORMANCE STATUS, AND PHYSICAL 
EXAMINATION VARIABLES 
Full physical examinations (PEs) are performed at Screening and at the end-of-treatment (EoT) 
visit; at other visits, symptom-directed physical exams may be conducted.  
Examinations include height, weight, BSA calculated by the Dubois method (Dubois and 
Dubois, 1916), and vital signs (heart rate, systolic and diastolic blood pressure, and body 
temperature). A Karnofsky performance status (KPS) assessment will be performed at 
Screening, Day 1 of each cycle, and the EoT visit.  
The actual value and change from baseline over time will be summarized for vital signs. 
Abnormal vital signs results will be summarized in the threshold/range analyses. 
Shift tables that present changes from baseline to worst on-study and last on-study KPS status 
will be presented. 
5.5. 
ELECTROCARDIOGRAM (ECG) 
Standard 12-lead ECG will be performed at Screening (or predose on cycle 1 day 1 [C1D1]) and 
the EoT visit.  
Changes from baseline for PR interval, QRS interval, and QT corrected using Fridericia's 
formula will be summarized using shift tables. For heart rate, changes from baseline will be 
presented. Abnormal ECG results will be summarized in the threshold/range analyses. 
Electrocardiogram data for each patient may also be provided in a data listing. 


Selinexor (KCP-330)                            
       
Karyopharm Therapeutics, Inc. 
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6. 
REFERENCES 
Ellingson, Benjamin M., Patrick Y. Wen, and Timothy F. Cloughesy. "Modified criteria for 
radiographic response assessment in glioblastoma clinical trials." Neurotherapeutics 14.2 
(2017): 307-320. 
Karyopharm Biostatistics and Statistical Programming Rule Book v2.0, Karyopharm 
Therapeutics Inc. 
 


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