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To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Granisetron
Sponsored by
Prostrakan Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

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

Inclusion Criteria: Patients must be of non-childbearing potential and female patients must have a negative pregnancy test at the Screening Visit Histologically and/or cytologically confirmed cancer with ECOG ≤2 Life expectancy of ≥ 3 months Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days Exclusion Criteria: Hypersensitivity to adhesive plasters Contraindications to 5-HT3 receptor antagonists Clinically relevant abnormal laboratory values or hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator Any cause for nausea and vomiting other than CINV Clinically relevant abnormal ECG parameters Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Percentage of patients achieving Complete Control of CINV from the first administration until 24 h after the last administration of the moderately or highly emetogenic chemotherapy

    Secondary Outcome Measures

    Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)
    Time from start of chemotherapy to first administration of rescue medication
    Time from start of chemotherapy to first emetic episode (vomiting/retching)
    Percentage of patients achieving CC and CR of CINV during different time periods
    Adverse events collected until 14 days after patch removal
    Patch adhesion

    Full Information

    First Posted
    January 6, 2006
    Last Updated
    May 2, 2008
    Sponsor
    Prostrakan Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00273468
    Brief Title
    To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)
    Official Title
    A Randomised, Active Control, Double-Blind, Double-Dummy, Parallel-Group, Multi-National Study to Assess the Efficacy, Tolerability and Safety of the Granisetron Transdermal Delivery System in Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With the Administration of Moderately or Highly Emetogenic Multi-Day Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Prostrakan Pharmaceuticals

    4. Oversight

    5. Study Description

    Brief Summary
    To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-Induced Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    630 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Granisetron
    Primary Outcome Measure Information:
    Title
    Percentage of patients achieving Complete Control of CINV from the first administration until 24 h after the last administration of the moderately or highly emetogenic chemotherapy
    Secondary Outcome Measure Information:
    Title
    Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)
    Title
    Time from start of chemotherapy to first administration of rescue medication
    Title
    Time from start of chemotherapy to first emetic episode (vomiting/retching)
    Title
    Percentage of patients achieving CC and CR of CINV during different time periods
    Title
    Adverse events collected until 14 days after patch removal
    Title
    Patch adhesion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must be of non-childbearing potential and female patients must have a negative pregnancy test at the Screening Visit Histologically and/or cytologically confirmed cancer with ECOG ≤2 Life expectancy of ≥ 3 months Assigned to receive the first cycle of a new multi-day chemotherapy regimen including the daily administration of cytotoxic agent(s) with the emetogenic potential of level 3-5 (Hesketh Classification) on 3-5 days Exclusion Criteria: Hypersensitivity to adhesive plasters Contraindications to 5-HT3 receptor antagonists Clinically relevant abnormal laboratory values or hepatic, renal, infectious, neurological or psychiatric disorders or any other major systemic illness at the discretion of the Investigator Any cause for nausea and vomiting other than CINV Clinically relevant abnormal ECG parameters Concomitant radiotherapy of total body, brain or upper abdomen within one week of study entry or planned during the study A patient taking a medication to control the symptoms of a brain tumour, brain metastasis or seizure disorder

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20835873
    Citation
    Boccia RV, Gordan LN, Clark G, Howell JD, Grunberg SM; Sancuso Study Group. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011 Oct;19(10):1609-17. doi: 10.1007/s00520-010-0990-y. Epub 2010 Sep 12.
    Results Reference
    derived

    Learn more about this trial

    To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)

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