NCT00273468CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 630
- Primary Endpoint
- 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
Study Overview
Brief Summary
To study the safety and effectiveness of a granisetron patch to treat Chemotherapy-Induced Nausea and Vomiting (CINV)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
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
- Adverse events collected until 14 days after patch removal
- Time from start of chemotherapy to first emetic episode (vomiting/retching)
- Percentage of patients achieving CC and CR of CINV during different time periods
- Patch adhesion
Investigators
Similar Trials
Completed
Phase 3
A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and VomitingChemotherapy-induced Nausea and VomitingNCT01937156Solasia Pharma K.K.313
Active, not recruiting
Phase 3
Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT05211232Sun Yat-sen University450
Terminated
Phase 2
A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate CancerProstate CancerNCT00780975PharmaMar8
Completed
Phase 2
A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LECNCT01054456Eisai Inc.36
Withdrawn
Phase 2
Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LBL)T Acute Lymphoblastic LeukemiaT Lymphoblastic LymphomaNCT06210750National Cancer Institute (NCI)