Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
NCT ID: NCT05199818
Last Updated: 2023-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
328 participants
INTERVENTIONAL
2022-03-01
2023-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Palonosetron HCl Buccal Film
Palonosetron HCl Buccal Film 0.5 mg 1 hr before administration of moderately emetogenic chemotherapy and normal saline injection 30 minutes before administration of moderately emetogenic chemotherapy
Palonosetron HCl Buccal Film 0.5 mg
Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
Palonosetron IV Injection
Placebo buccal film 1 har before administration of moderately emetogenic chemotherapy and Palonosetron HCl Injection 0.25 mg 30 min before administration of moderately emetogenic chemotherapy
IV Palonosetron 0.25 mg
IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1
Interventions
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Palonosetron HCl Buccal Film 0.5 mg
Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1
IV Palonosetron 0.25 mg
IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Xiamen LP Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Pacific Cancer Medical Center
Anaheim, California, United States
Watson Clinic
Lakeland, Florida, United States
Lakes Research
Miami Lakes, Florida, United States
Florida Cancer Affiliates
Ocala, Florida, United States
Summit Cancer Care
Savannah, Georgia, United States
Edward H. Kaplan MD & Associates
Skokie, Illinois, United States
Orchard Healthcare research, Inc.
Skokie, Illinois, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Tri-County Hematology & Oncology Associates
Massillon, Ohio, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Ajit Maniam, Dr
Role: primary
Shalini Mulaparthi, MD
Role: primary
Eloy Roman, MD
Role: primary
Anju Vasudevan, MD
Role: primary
Mark Taylor, MD
Role: primary
Edward H Kaplan, MD
Role: primary
Ralph Boccia, MD
Role: primary
Scott McGee, MD
Role: primary
Satish A Shah, MD
Role: primary
Other Identifiers
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LP-CT-PALO-202101
Identifier Type: -
Identifier Source: org_study_id
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