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

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Drug: Granisetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00273468

392MD/15/C

Details and patient eligibility

About

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

Sex: All

Ages: 15+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind