Clinical trial NCT00273468: To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 630
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: Times from start of chemotherapy to treatment failure for complete control (CC) and complete response (CR)
measure: Time from start of chemotherapy to first administration of rescue medication
measure: Time from start of chemotherapy to first emetic episode (vomiting/retching)
measure: Percentage of patients achieving CC and CR of CINV during different time periods
measure: Adverse events collected until 14 days after patch removal
measure: Patch adhesion
Other outcomes:
Locations:
Study officials:
References:
citation: 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.