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

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

Official Title
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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

Conditions
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Chemotherapy-Induced Nausea and Vomiting

Intervention / Treatment
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* Drug: Granisetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Granisetron|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |