Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
- Registration Number
- NCT00684463
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- Patients must be 18 years of age or older.
- Histological or cytological confirmation of malignant disease.
- Karnofsky index >= 50%
- Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
- Patients that voluntarily sign the consent form.
Exclusion Criteria
- Pregnancy or suspected.
- Patients during breast feeding.
- Inability to understand or cooperate with the study procedures.
- Received any investigational drugs within 30 days before study entry.
- Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
- Seizure disorders requiring anticonvulsant medication.
- Persistent vomiting due to any organic etiology.
- Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
- Any systemic disease different to base disease
- Known current or history of drug or alcohol abuse
- Gastric outlet or intestinal obstruction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Palonosetron Palonosetron 0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent
- Primary Outcome Measures
Name Time Method Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication. During 24 hours after administration of chemotherapy.
- Secondary Outcome Measures
Name Time Method Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication Days 1 to 5 at different time intervals for each secondary outcome. Number of emetic episodes Days 1 to 5 at different time intervals for each secondary outcome. Proportion of patients who achieved a CR and of those who achieved complete control Days 1 to 5 at different time intervals for each secondary outcome.