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5-HT3 Receptor Antagonist
Palonosetron HCl Buccal Film 0.5 mg for CINV
Phase 3
Waitlist Available
Research Sponsored by Xiamen LP Pharmaceutical Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new way to give palonosetron, a drug that prevents nausea and vomiting from chemotherapy, using a dissolvable film in the mouth instead of an injection. It targets cancer patients who often feel sick from their treatment. The drug works by stopping the brain signals that make you feel nauseous and vomit.
Eligible Conditions
- CINV
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Absence of nausea
Complete control
Complete response
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Palonosetron HCl Buccal FilmExperimental Treatment1 Intervention
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
Group II: Palonosetron IV InjectionActive Control1 Intervention
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
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Who is running the clinical trial?
Xiamen LP Pharmaceutical Co., LtdLead Sponsor
1 Previous Clinical Trials
22 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken any medication that helps prevent nausea and vomiting within the last day before treatment and during the study.You have a seizure disorder that requires medication to control seizures.You are currently experiencing frequent vomiting that is caused by a medical condition.You have a known reason why you cannot take medications called 5-HT3 antagonists or dexamethasone.You have been diagnosed with cancer, either for the first time and have not received chemotherapy before, or you have received chemotherapy before and have a confirmed diagnosis of cancer.You have a history of feeling very sick or throwing up after receiving chemotherapy.You are able to perform daily activities with at least half of your usual energy and ability.
Research Study Groups:
This trial has the following groups:- Group 1: Palonosetron HCl Buccal Film
- Group 2: Palonosetron IV Injection
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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