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

Primary Purpose

Neoplasms, Nausea, Vomiting

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Palonosetron
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms focused on measuring Antiemetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Palonosetron

    Arm Description

    0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent

    Outcomes

    Primary Outcome Measures

    Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.

    Secondary Outcome Measures

    Proportion of patients who achieved a CR and of those who achieved complete control
    Number of emetic episodes
    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

    Full Information

    First Posted
    May 22, 2008
    Last Updated
    May 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00684463
    Brief Title
    Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 11, 2007 (Actual)
    Primary Completion Date
    February 22, 2008 (Actual)
    Study Completion Date
    February 22, 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neoplasms, Nausea, Vomiting
    Keywords
    Antiemetic

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    59 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Palonosetron
    Arm Type
    Experimental
    Arm Description
    0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent
    Intervention Type
    Drug
    Intervention Name(s)
    Palonosetron
    Other Intervention Name(s)
    SCH 734291 - Onicit®
    Intervention Description
    0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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.
    Title
    Number of emetic episodes
    Time Frame
    Days 1 to 5 at different time intervals for each secondary outcome.
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Snyopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

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

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