Clinical trial NCT04592198
Conditions: Nausea With Vomiting Chemotherapy-Induced
Sponsor: Xiamen LP Pharmaceutical Co., Ltd
Start date: 2020-10-01; Completion date: 2021-03-25
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

Detailed description:
This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.

Arms: arm 1: Palonosetron HCl Buccal Film 0.25 Mg arm 2: Palonosetron HCl Buccal Film 0.5 Mg arm 3: IV palonosetron 0.25 Mg (ALOXI®)
Interventions: intervention 1: Palonosetron Hydrochloride Buccal Film 0.25 Mg intervention 2: Palonosetron Hydrochloride Buccal Film 0.5 Mg intervention 3: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution
Intervention descriptions: intervention 1: Dose equal to the iv control intervention 2: Dose twice that of iv control intervention 3: iv control

Protocol documents:
Prot_SAP_001.pdf: 
Xiamen LP Pharmaceutical Co., Ltd. 
Protocol Number: LP-CT-PALO-202002 
LP035 
Final 2.0 
12-August-2020 
Page 1 of 4 
CONFIDENTIAL 
 
 
Protocol Number: LP-CT-PALO-202002 
 
 
 
 
Study Title 
A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the Efficacy, 
Safety and Pharmacokinetics of Palonosetron HCl Buccal Film versus IV Palonosetron 
0.25 mg (ALOXI®) for the Prevention of Chemotherapy-induced Nausea and Vomiting 
in Cancer Patients Receiving Moderately Emetogenic Chemotherapy 
NCT Number 
NCT04592198 
Protocol Number 
LP-CT-PALO-202002 
Protocol Version 
2.0 
Protocol Date 
12 August 2020 
 
 


Xiamen LP Pharmaceutical Co., Ltd. 
Protocol Number: LP-CT-PALO-202002 
LP035 
Final 2.0 
12-August-2020 
Page 2 of 4 
CONFIDENTIAL 
 
 
SYNOPSIS 
 
Study Number: 
LP-CT-PALO-202002 
Name of 
Investigational 
Product: 
Palonosetron HCl Buccal Film (LP035) 
Title of Study: 
A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the 
Efficacy, Safety and Pharmacokinetics of Palonosetron HCl Buccal Film versus IV 
Palonosetron 0.25 mg (ALOXI®) for the Prevention of Chemotherapy-induced Nausea 
and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy 
Indication: 
Prevention of acute and delayed nausea and vomiting associated with moderately 
emetogenic cancer chemotherapy 
Development Phase: 
2 
Objectives: 
To compare the efficacy, safety and pharmacokinetics of single dose of Palonosetron 
HCl Buccal Film 0.25 mg or 0.5 mg to IV palonosetron 0.25 mg in the prevention of 
chemotherapy-induced nausea and vomiting in cancer patients receiving moderately 
emetogenic chemotherapy 
Study Population: 
The study population will consist of male or female adult chemotherapy naïve  (i.e. no 
history of cytotoxic chemotherapy) or non-naïve patients with histologically or 
cytologically confirmed solid tumors, scheduled to receive MEC. 
Study Design: 
This is a randomized, open-label, multicenter, parallel group, dose-ranging efficacy, 
safety and pharmacokinetic study. Patients will be randomized into three treatment 
groups. 
Number of Subjects: 
22 subjects will be randomized into three treatment groups, 8 subjects in 0.25 mg 
LP035 group, 8 subjects in 0.5 mg LP035 group, 6 subjects in 0.25 mg ALOXI® group. 
Palonosetron PK will be assessed in a subgroup of patients in 12 patients, 4 patients per 
group. 
Study Duration: 
Patients not included in the PK subgroups, will stay on the study for a maximum of 16 
days including an up to 7-days screening period, 6 days on study (control phase) and a 
follow-up patient visit or telephone call 3 days after control phase. 
Patients involved in the PK subgroups will stay on the study for a maximum of 18 days 
including an up to 7-days screening period, 8 days on study (6 days control phase, and 
an additional 2 days PK phase) and a follow-up patient visit or telephone call 3 days 
after the PK phase. 
Treatment Groups: 
Divided into 3 groups： 
Test Drug 
Palonosetron HCl Buccal Film 0.25 mg, administered on Day 1,  
(Group A): 
8 subjects; 
Test Drug 
Palonosetron HCl Buccal Film 0.5 mg, administered on Day 1, 
(Group B): 
8 subjects; 
Reference 
IV palonosetron 0.25 mg (ALOXI®), administered on Day 1 
(Group C): 
6 subjects. 
Criteria for Inclusion: 
For inclusion in the study, patients must fulfill all of the following criteria: 
1. Provide written informed consent; 
2. Male or female, aged ≥ 18 years; 
3. With histologically or cytologically confirmed malignant disease; 
4. Patients and patients’ partners using reliable contraceptive measures; 


Xiamen LP Pharmaceutical Co., Ltd. 
Protocol Number: LP-CT-PALO-202002 
LP035 
Final 2.0 
12-August-2020 
Page 3 of 4 
CONFIDENTIAL 
 
 
 
Criteria for Inclusion: 
5. Female patient of childbearing potential having a negative serum pregnancy test;  
6. Be able to read, understand, and follow the study procedures and able to complete 
patient diary autonomously. 
Exclusion Criteria: 
Any of the following is regarded as a criterion for exclusion from the study: 
1. Expect to be non-compliant with the study procedures; 
2. Receive any investigational drugs within 30 days before the start of study 
treatment or schedule to receive a highly or moderately emetogenic 
chemotherapeutic agent; 
3. Have a clinically unstable seizure disorder with seizure activity requiring 
anticonvulsant medication; 
4. Have severe renal or hepatic impairment; 
5. Have positive serology test results; 
6. Have a known contraindication to 5-HT3 receptor antagonists; 
7. Treat with commercially available palonosetron formulations within 2 weeks prior 
to start of study treatment or enrollment in a previous trial investigating 
palonosetron; 
8. Is allergic to palonosetron or any other 5-HT3 antagonist; 
9. Is currently a user of any recreational or illicit drugs (including marijuana) or has 
current evidence of drug or alcohol abuse or dependence as determined by the 
investigator; 
10. Will be receiving stem cell rescue therapy in conjunction with study related course 
of emetogenic chemotherapy; 
11. Has received or will receive total body irradiation or radiation therapy to the 
abdomen (includes the level of the diaphragm and below) or pelvis in the week 
prior to Treatment Day 1 and/or during the diary reporting period. 
Study Treatments: 
Test Drug 
(Group A): 
Administration of Palonosetron HCl Buccal Film 0.25 mg 
on Day 1, 60 ± 10 min before start of Chemotherapy. 
Test Drug 
(Group B): 
Administration of Palonosetron HCl Buccal Film 0.5 mg 
on Day 1, 60 ± 10 min before start of Chemotherapy.  
Reference 
(Group C): 
IV palonosetron 0.25 mg (ALOXI®) administered on Day 
1, 30 ± 5 minutes before start  of Chemotherapy, as an IV 
bolus over 30 seconds. 
Schedule of Patient Visits: 
Patients will undergo the following visits: 
• 
Screening: Visit 1 (Day -7 to Day -1); 
• 
Visit 2 (Day 1): chemotherapy and study drug administration; 
• 
Visit 3 (Day 2): 24 hours after the start of chemotherapy administration 
• 
Visit 4 (Day 6 [+2 days]/Day 8): 120 [up to 175] hours after start of 
chemotherapy administration 
• 
Visit 5 (Day 9 [± 1 day]/Day 11 [± 1 day]): follow-up [visit or 
phone contact]. 
Chemotherapy Regimens: 
Any MEC (ASCO Guideline), taken on Day 1 is allowed. If more than one agent 
considered as MEC is administered on Day 1, the start time of the first agent is to be 
considered as the start of chemotherapy. 
Any chemotherapy agent of high or moderate emetogenicity during the period from Day 
2 up to 120 hours after start of chemotherapy is not allowed. 


Xiamen LP Pharmaceutical Co., Ltd. 
Protocol Number: LP-CT-PALO-202002 
LP035 
Final 2.0 
12-August-2020 
Page 4 of 4 
CONFIDENTIAL 
 
 
 
Efficacy Assessments: 
Primary Endpoint: 
Complete response (CR) (no emetic episode and no rescue medication) during the first 
24 hours after chemotherapy. 
Safety Assessments: 
Safety assessments include the recording and assessing of all adverse events (AEs), vital 
signs, physical examinations (PE), clinical laboratory parameters, 12-lead 
electrocardiogram (ECG), buccal application site evaluation at 0.5 hour (for all subjects),
24 hours (for all subjects) post-dose and at Visit 4 (day 8 for PK subgroups, day 6-8 for 
non-PK subgroups). 
Analysis Sets: 
The full analysis set (FAS) is defined as all randomized patients who received the study 
medication and at least chemotherapy. The analysis based on the FAS is considered as 
primary analysis for all efficacy parameters. 
The per-protocol (PP) set is defined as all patients who completed Day 2 (primary 
endpoint) and who is compliant with the study protocol. 
Pharmacokinetic set (PKS) is defined as all subjects completing the study and for 
whom the pharmacokinetic profile can be adequately characterized. 
The safety set (SS) is defined as all patients treated and have at least one safety 
assessment after treatment. "Patients treated" is defined as any patient who received any 
study medication (palonosetron). 
Pharmacokinetic: 
Parameters: AUC0-t, AUC0-inf, Cmax, Residual area, Tmax, T½ el, and kel. 
Statistical Methods: 
Efficacy: 
The primary analysis will be summarized by treatment arm. The number and 
proportion of patients will be presented by frequency table. For the response rate and 
for the difference in response rate between each Palonosetron HCl Buccal Film group 
and IV palonosetron group, 95% confidence interval (CI) will be provided. 
For the CR rate at 24 h, analyses will be carried out for both FAS and PP population; 
the other parameters will be analyzed only for FAS population. 
The subgroups will be analyzed based on FAS for the primary efficacy by age, gender, 
chemotherapy history, ethanol use, history of pregnancy-related morning sickness, 
history of motion sickness. The between-group treatment effect (with a nominal 95% 
CI) for the primary endpoint will be estimated within each category. 
Safety: 
The analysis of safety will be performed for the safety set. The result will be 
interpreted in a descriptive manner. Incidence of AEs will be calculated overall, by 
system organ and by preferred term. 
Physical examination, vital signs, 12-lead electrocardiogram and application site 
evaluation data will be listed and summarized. For vital signs, differences will be 
calculated compared to baseline. 
Laboratory data will be analyzed and described considering the age and/or gender 
dependent normal ranges of the local laboratory. Laboratory data will be summarized and 
listed. Marked abnormalities and assessments concerning clinical relevance for abnormal 
values will be included. Shift tables will be used for vital signs and laboratory data to 
evaluate categorical changes with respect to normal ranges. 
Sponsor: 
Xiamen LP Pharmaceutical Co., Ltd.