Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00684463
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Neoplasms Nausea Vomiting Drug: Palonosetron Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 11, 2007
Actual Primary Completion Date : February 22, 2008
Actual Study Completion Date : February 22, 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Palonosetron
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent
Drug: Palonosetron
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
Other Name: SCH 734291 - Onicit®

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. Number of emetic episodes [ Time Frame: Days 1 to 5 at different time intervals for each secondary outcome. ]
  3. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Data/Documents: CSR Snyopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00684463     History of Changes
Other Study ID Numbers: P04935
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents