Chemotherapy-induced Nausea and Vomiting
Conditions
Brief summary
To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)
Interventions
DRUGGranisetron
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time from start of chemotherapy to first administration of rescue medication | — |
| Time from start of chemotherapy to first emetic episode (vomiting/retching) | — |
| Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR) | — |
| Adverse events collected until 14 days after patch removal | — |
| Patch adhesion | — |
| Percentage of patients achieving CC and CR of CINV during different time periods | — |
Outcome results
None listed