Chemotherapy-induced Nausea and Vomiting
Conditions
Brief summary
The phase 3 study is to compare the efficacy and safety of palonosetron, a long-acting 5-HT3 receptor antagonist, by buccal film delivery compared to IV injection for the prevention of chemotherapy-induced nausea and vomiting. Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.
Detailed description
This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC). Subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).
Interventions
DRUGPalonosetron HCl Buccal Film 0.5 mg
Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
DRUGIV Palonosetron 0.25 mg
IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1
Sponsors
Xiamen LP Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, at least 18-years of age; 2. Provide written informed consent; 3. Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer; 4. Karnofsky index ≥ 50; 5. Be scheduled to receive MEC to be administered on Day 1;
Exclusion criteria
1. Unable to understand or cooperate with study procedure； 2. Received any investigational drug 30 days prior to study entry； 3. Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study； 4. Enrollment in a previous study with palonosetron； 5. Seizure disorder requiring anticonvulsant medication; 6. Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy； 7. Ongoing vomiting from any organic etiology； 8. Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)； 9. Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study； 10. Known contraindication to 5-HT3 antagonist or dexamethasone； 11. Scheduled to receive bone marrow or stem cell transplant during study; 12. Symptomatic primary or metastatic CNS malignancy; 13. Lactating female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | During the first 24 hours after chemotherapy | No emetic episode and no rescue medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | 24-120 hours post chemotherapy | No emetic episode and no rescue medication |
| Absence of nausea | up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy | Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication |
| Complete control | up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy | The proportion of patients with complete control |
| Number of emetic episodes | up to 120 hours after chemotherapy | Number of emetic episodes |
Countries
United States
Contacts
Primary ContactMatthew H Nieder, Ph.D.
Backup ContactLinhui Cai, MS
Outcome results
None listed