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

Condition	Intervention	Phase
Chemotherapy-Induced Nausea and Vomiting	Drug: Granisetron	Phase III

Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  630

Ages Eligible for Study:  15 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00273468

Medical Expert      +33 (0) 1 49 42 46 46    RD@prostrakan.com

Study ID Numbers:  392MD/15/C
Last Updated:  January 6, 2006
Record first received:  January 6, 2006
ClinicalTrials.gov Identifier:  NCT00273468
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10