To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea… (NCT00273468) | Clinical Trial Compass
CompletedPhase 3
To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)
630 participantsStarted 2006-01
Plain-language summary
To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)
Who can participate
Age range15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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