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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00684463
First received: May 22, 2008
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Neoplasms
Nausea
Vomiting
Drug: Palonosetron
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

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 ]

Estimated Enrollment: 152
Study Start Date: April 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palonosetron Drug: Palonosetron
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
Other Name: SCH 734291 - Onicit®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00684463     History of Changes
Other Study ID Numbers: P04935
Study First Received: May 22, 2008
Last Updated: May 23, 2008
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Schering-Plough:
Antiemetic

Additional relevant MeSH terms:
Neoplasms
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Emetics
Palonosetron
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014