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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prostrakan Pharmaceuticals
• Treatments: Granisetron

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