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

392MD/15/C

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

2006-01-01

2006-10-01

Completed

Early phase I

630

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 630}}

2024-06-17