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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00684463
Collaborator
(none)
59
Enrollment
1
Arm
10.4
Actual Duration (Months)

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
N/A
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 :
Apr 11, 2007
Actual Primary Completion Date :
Feb 22, 2008
Actual Study Completion Date :
Feb 22, 2008

Arms and Interventions

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 Names:
  • SCH 734291 - Onicit®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.]

    2. Number of emetic episodes [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 [Days 1 to 5 at different time intervals for each secondary outcome.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00684463
    Other Study ID Numbers:
    • P04935
    First Posted:
    May 26, 2008
    Last Update Posted:
    May 16, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Merck Sharp & Dohme LLC
    Antiemetic
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Palonosetron

    Study Results

    No Results Posted as of May 16, 2017