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

June 14, 2024 updated by: Kyowa Kirin Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

630

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

January 6, 2006

First Submitted That Met QC Criteria

January 6, 2006

First Posted (Estimated)

January 9, 2006

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 392MD/15/C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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