Clinical trial NCT04054193
Conditions: Chemotherapy-induced Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2019-09-09; Completion date: 2021-02-11
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.

Detailed description:
Upon completion of Cycle 1, participants were given the option to exit the study and be considered completed, or to continue on study therapy for up to 2 more (optional) 17-day cycles of chemotherapy where fosaprepitant was administered and additional safety data collected.

Arms: arm 1: Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT3\]) receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
Interventions: intervention 1: Fosaprepitant Dimeglumine intervention 2: 5-HT3 antagonist intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age). intervention 2: All participants received an oral 5-hydroxytryptamine (serotonin; \[5-HT\]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care. intervention 3: Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.

Protocol documents:
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Product: MK-0517
PAGE 1
sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
Supplemental Statistical Analysis Plan (sSAP)
Protocol Title:
A Phase 4, Open-label, Single Arm Study to 
Evaluate the Safety and Tolerability of a Three-day Fosaprepitant 
Regimen Administered for the Prevention of Chemotherapy-
Induced Nausea and Vomiting (CINV) in Pediatric Participants 
Receiving Emetogenic Chemotherapy. 
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sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
TABLE OF CONTENTS
TABLE OF CONTENTS ....................................................................................................... 2
LIST OF TABLES.................................................................................................................. 3
1.
INTRODUCTION....................................................................................................... 4
2.
SUMMARY OF CHANGES...................................................................................... 4
3.
ANALYTICAL AND METHODOLOGICAL DETAILS ...................................... 4
STATISTICAL ANALYSIS PLAN SUMMARY................................................ 4
RESPONSIBILITY FOR ANALYSES/IN-HOUSE BLINDING....................... 5
HYPOTHESES/ESTIMATION ............................................................................ 5
ANALYSIS ENDPOINTS...................................................................................... 5
3.4.1
Safety Endpoints ................................................................................................. 5
SAFETY ANALYSIS POPULATIONS................................................................ 6
STATISTICAL METHODS.................................................................................. 6
3.6.1
Statistical Methods for Efficacy Analyses......................................................... 6
3.6.2
Statistical Methods for Safety Analyses............................................................ 6
3.6.3
Demographics and Baseline Characteristics .................................................... 8
INTERIM ANALYSES.......................................................................................... 9
MULTIPLICITY .................................................................................................... 9
SAMPLE SIZE AND POWER CALCULATIONS............................................. 9
SUBGROUP ANALYSES...................................................................................... 9
COMPLIANCE (MEDICATION ADHERENCE).............................................. 9
EXTENT OF EXPOSURE..................................................................................... 9
4.
APPENDICES........................................................................................................... 10
Additional analyses accounting for possible COVID-19 impact ...................... 10
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Product: MK-0517
PAGE 3
sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
LIST OF TABLES
Table 1
Analysis Strategy for Safety Parameters .................................................................. 7
Table 2
Predefined Limits of Change.................................................................................... 8
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Product: MK-0517
PAGE 4
sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
1. INTRODUCTION
This supplemental SAP (sSAP) is a companion document to the protocol. In addition to the
information presented in the protocol SAP which provides the principal features of 
confirmatory analyses for this trial, this supplemental SAP provides additional statistical 
analysis details/data derivations and documents modifications or additions to the analysis 
plan that are not “principal” in nature and result from information that was not available at 
the time of protocol finalization.
2. SUMMARY OF CHANGES
Date
Page
Changes
27AUG2020
7
Added PDLC definition
27AUG2020
5
Added summary table and listing for COVID-19 related events
3. ANALYTICAL AND METHODOLOGICAL DETAILS
STATISTICAL ANALYSIS PLAN SUMMARY
Key elements of the statistical analysis plan are summarized below. The comprehensive plan 
is provided in Sections 3.2 – Responsibility for Analyses/In-House Blinding to 
3.12 – Extent of Exposure.
Study Design Overview
A Phase 4, Open-label, Single Arm Study to Evaluate the 
Safety and Tolerability of a Three-day Fosaprepitant Regimen 
Administered for the Prevention of Chemotherapy-Induced 
Nausea and Vomiting (CINV) in Pediatric Participants 
Receiving Emetogenic Chemotherapy
Treatment Assignment
Single Arm, Unblinded, Open-label 
Analysis Populations
Efficacy: Not applicable for this safety study
Safety: All Participants as Treated (APaT)
Primary Endpoint
•AEs
   •Discontinuation due to AEs
Key Secondary 
Endpoints
There are no key secondary endpoints in this study.
Statistical Methods for 
Key
Efficacy/Immunogenicity/ 
Pharmacokinetic 
Analyses
Not applicable for this safety study.
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Product: MK-0517
PAGE 5
sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
Statistical Methods for 
Key Safety Analyses
This is a single treatment arm safety study.
In Cycle 1, proportions will be displayed for AEs, SAE(s), 
drug-related AE(s), and AE(s) leading to discontinuation 
from study intervention, which occur during the fosaprepitant 
treatment period plus 14 days post last dose of study 
intervention.
For optional Cycles 2 and 3, proportions will be displayed for 
SAE(s), drug-related AE(s), and AE(s) leading to 
discontinuation from study intervention which occur during the 
fosaprepitant treatment period plus 14 days post last dose of 
study intervention.
Interim Analyses
There are no planned interim analyses for this study.
Multiplicity
No multiplicity adjustment is planned forfs this study.
Sample Size and Power 
The planned sample size is 100 participants.
RESPONSIBILITY FOR ANALYSES/IN-HOUSE BLINDING
The statistical analysis of the data obtained from this study will be the responsibility of the 
Clinical Biostatistics Department of the Sponsor.
Cycle 1 and optional Cycles 2 and 3 of this study are being conducted as a non-randomized, 
open-label study, ie, participants, investigators, and Sponsor personnel will be aware of 
participant treatment assignments after each participant is enrolled and treated.
Results from all 3 cycles of chemotherapy will be presented in the CSR.
HYPOTHESES/ESTIMATION
There will be no hypotheses for this safety study.
ANALYSIS ENDPOINTS
This is a safety study; therefore, efficacy data will not be collected. Safety data will be 
evaluated in all cycles.
3.4.1
Safety Endpoints
Safety endpoints in Cycle 1 will be assessed by evaluation of all clinical and laboratory AEs 
including those that are considered drug-related, serious, serious drug-related, lead to 
discontinuation of study intervention, or other reportable safety events.
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Product: MK-0517
PAGE 6
sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
Safety endpoints in Cycle 2 and 3 will be assessed by evaluation of all SAEs, drug-related
AEs, AEs that lead to discontinuation of study intervention, and other reportable safety 
events.
Safety and tolerability will also include assessment of additional study parameters including 
vital signs, physical examination, ECGs, and laboratory safety tests.
SAFETY ANALYSIS POPULATIONS
Safety analyses will be conducted in the APaT population, which consists of all allocated 
participants who received at least one dose of study treatment.
At least one laboratory, vital sign, or ECG measurement obtained subsequent to at least one 
dose of study intervention is required for inclusion in the analysis of the respective safety 
parameter. To assess change from baseline, a baseline measurement is also required.
STATISTICAL METHODS
Additional data summaries and listings to account for potential COVID-19 impact are 
provided in Appendix 4.1.
3.6.1
Statistical Methods for Efficacy Analyses
There will be no efficacy analyses in this study.
3.6.2
Statistical Methods for Safety Analyses
Safety and tolerability will be assessed by clinical review of all relevant parameters including 
AEs, laboratory tests, vital signs, and ECG measurements.
The broad clinical and laboratory AE categories consisting of the percentage of participants 
with any AE, a drug-related AE, a serious AE, an AE which is both serious and drug-related, 
or who discontinued due to an AE will be summarized with descriptive statistics. AEs 
(specific as well as System Organ Class [SOC]) and continuing measures such as changes 
from baseline in laboratory, vital signs, and ECG parameters, will be provided in table format 
(Table 1).
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Product: MK-0517
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sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
Table 1
Analysis Strategy for Safety Parameters
Safety Endpoint
Descriptive Statistics
Any AE
Any Serious AE
Any Drug-Related AE
Any Serious and Drug-Related AE
Discontinuation due to AE
Discontinuation due to a Drug-Related AE
Specific AEs, SOCs
Change from Baseline Results (Labs, ECGs, Vital Signs)
X
X
X
X
X
X
X
X
AE = adverse event, SOC = system organ class, X = results will be provided
The following predefined limits of change in Table 2 will be assessed.
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sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
Table 2
Predefined Limits of Change
Laboratory Test
Criteria
Hematocrit
Decrease ≥20% and value <LLN
Increase ≥20% and value >ULN
WBC
Decrease ≥20% and value <LLN
Increase ≥20% and value >ULN
Platelet
Decrease ≥25% and value <LLN
Increase ≥50% and value >ULN
Bilirubin
Increase ≥100% and value >ULN
Increase ≥50% and value >1.5x ULN
Increase ≥50% and value >2x ULN
Increase ≥50% and value >3x ULN
Increase ≥50% and value >5x ULN
AST
Increase ≥100% and value >ULN
Increase ≥50% and value >1.5x ULN
Increase ≥50% and value >2x ULN
Increase ≥50% and value >3x ULN
Increase ≥50% and value >5x ULN
ALT
Increase ≥100% and value >ULN
Increase ≥50% and value >1.5x ULN
Increase ≥50% and value >2x ULN
Increase ≥50% and value >3x ULN
Increase ≥50% and value >5x ULN
Neutrophil
Decrease ≥20% and value <LLN
Increase ≥20% and value >ULN
BUN
Increase ≥50% 
Increase ≥20% and value BLN >ULN
Serum creatinine
Increase ≥50% 
Increase ≥20% and value BLN >ULN
†Increases and decreases are relative to baseline.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
BLN = baseline; BUN = blood urea nitrogen; LLN = Lower limit of normal range; ULN = Upper 
limit of normal range; WBC = white blood cell.
3.6.3
Demographics and Baseline Characteristics 
For each relevant demographic and baseline characteristic, descriptive statistics will be 
assessed by the use of tables and/or graphs. No statistical hypothesis tests will be performed 
on these characteristics. The number and percentage of participants screened, allocated, the 
primary reasons for screening failure, and primary reasons for discontinuation will be 
displayed. Demographic variables (eg, age), baseline characteristics, and prior and 
concomitant therapies will be summarized either by descriptive statistics or categorical table. 
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Product: MK-0517
PAGE 9
sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
INTERIM ANALYSES
No interim analyses are planned for this study. 
MULTIPLICITY
No multiplicity adjustment is planned since no hypothesis testing will be conducted in this 
study.
SAMPLE SIZE AND POWER CALCULATIONS
The planned sample size is 100 participants. With a sample size of 100 participants, if the
underlying incidence rate is 1% then the probability of observing ≥1 AE is 0.63; furthermore, 
if the underlying incidence rate is 5% then the probability of observing ≥1 AE is 0.99.
SUBGROUP ANALYSES
All results will be displayed by the 4 age groups (6 months to <2 years, 2 to <6 years, 6 to 
<12 years, and 12 to 17 years).
COMPLIANCE (MEDICATION ADHERENCE)
Study intervention will be administered in a supervised clinical setting and missed or 
incorrect dosing will be uncommon. Participants who miss a dose or take an incorrect dose 
will be described in the CSR as to why the dose was missed or incorrect. 
EXTENT OF EXPOSURE
The extent of exposure (dose and duration) to fosaprepitant will be summarized by the 
number of participants exposed to fosaprepitant for defined periods of time.
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Product: MK-0517
PAGE 10
sSAP - 17-November-2020
Protocol/Amendment No.: 045-00 
4. APPENDICES
Additional analyses accounting for possible COVID-19 impact 
In order to assess the impact of COVID-19, the following listings and summaries will be 
provided in the CSR as follows:
•
The Summary table of PDs Associated with COVID-19
•
The corresponding listing
The COVID-19 PD listings will include information in terms of impact (WHAT was 
impacted, HOW was it impacted and WHEN was it impacted) will be saved in the Deviations 
Cumulative Report (DCR) prior to Database Lock (DBL). 
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