Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: May 22, 2008
Last updated: May 2, 2014
Last verified: May 2014
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.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||Study 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 in Colombia
Primary Outcome Measures:
- Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication. [ Time Frame: During 24 hours after administration of chemotherapy. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients who achieved a CR and of those who achieved complete control [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ] [ Designated as safety issue: No ]
- Number of emetic episodes [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2008 (Final data collection date for primary outcome measure)
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
Other Name: SCH 734291 - Onicit®
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
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No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 22, 2008
||May 2, 2014
||Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 27, 2015
Signs and Symptoms
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs