Status:
COMPLETED
To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00273468
Start Date
January 1 2006
End Date
October 1 2006
Last Update
June 17 2024
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