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

Last updated: June 14, 2024
Sponsor: Kyowa Kirin Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Effects Of Chemotherapy

Lactose Intolerance

Colic

Treatment

Granisetron

Clinical Study ID

NCT00273468
392MD/15/C
  • Ages > 15
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be of non-childbearing potential and female patients must have anegative 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 regimenincluding the daily administration of cytotoxic agent(s) with the emetogenicpotential of level 3-5 (Hesketh Classification) on 3-5 days

Exclusion

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 thediscretion 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 ofstudy entry or planned during the study

  • A patient taking a medication to control the symptoms of a brain tumour, brainmetastasis or seizure disorder

Study Design

Total Participants: 630
Treatment Group(s): 1
Primary Treatment: Granisetron
Phase: 3
Study Start date:
January 01, 2006
Estimated Completion Date:
October 31, 2006