To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)

NCT00273468 | Completed Phase 3

• 1 other identifier: 392MD/15/C
• Study Type: interventional
• Target: 630
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (6)

• 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

Interventions

Granisetron DRUG

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Related Publications (1)

• Boccia RV, Gordan LN, Clark G, Howell JD, Grunberg SM; Sancuso Study Group. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011 Oct;19(10):1609-17. doi: 10.1007/s00520-010-0990-y. Epub 2010 Sep 12.

  PMID: 20835873 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 9, 2006
• Study Start: January 1, 2006
• Study Completion: October 1, 2006
• Last Updated: June 17, 2024

Record last verified: 2024-06