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 (GTDS) in chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic multi-day chemotherapy.

• Conditions: Chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic multi-day chemotherapy.

• Registration Number: EUCTR2005-005003-41-CZ
• Lead Sponsor: Strakan Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-15
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

•Male or female aged =18 yrs (no upper limit)
•Patients must be of non-childbearing potential, i.e:
•A surgically sterilised (tubal ligation and/or hysterectomy) female patient
•A female patient with a surgically sterilised male partner (vasectomy)
•A female patient using a highly effective method of birth control (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; contraceptive implant; contraceptive skin patch or cervical ring) for 30 days prior to the start of the study, and agree to continue such precautions for one month after study completion.
•A post-menopausal female patient (amenorrhoea for at least one year prior to Screening Visit)
•Female patients must have a negative pregnancy test at the Screening Visit.
•Histologically and/or cytologically confirmed cancer with Eastern Cooperative Oncology Group (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
•Patients able to read and write at a competent level to understand the study procedures and capable of giving legal consent.
•Patients having provided written informed consent
The study will aim to select countries and centres to ensure that a representative patient population with regard to ethnic and racial background will be included in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The presence of any of the following criteria constitutes a cause for the exclusion of the patient from the study:
Previous History
•Hypersensitivity to adhesive plasters
•Contraindications to 5-HT3 receptor antagonists
•Patients who have already been included in a clinical study with the GTDS
•Any other relevant medical history at the discretion of the Investigator
Concomitant Medical Condition
•Current alcohol, drug or medication abuse
•Breast feeding women
•Clinically relevant abnormal laboratory values at the discretion of the Investigator
•Clinically relevant 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
•Any episode of retching, vomiting or uncontrolled nausea within 72 h prior to the administration of the chemotherapy
•Clinically relevant ECG parameters at the discretion of the Investigator and/or QTc >450ms for male patients and QTc > 470ms for female patients
•Mental conditions rendering the patient unable to understand the nature, scope and possible consequences of the study
Concomitant Therapy/Medication
•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
•Patients using SSRI antidepressants (unless they are on a stable dose for the duration of the study)
•Receipt of any other investigational drug <30 days before the study or during the study
•Scheduled to receive a NK1 receptor antagonists, dopamine receptor antagonist or another 5-HT3 receptor antagonist between 72 h prior to the administration of the chemotherapy and patch removal (Visit 6)
Drugs known to increase the QTc interval
Other
•Patients unlikely to comply with the study protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
In addition to these exclusion criteria, patients will be withdrawn from the study if the patch is more than 50% detached from the patient’s skin at Visit 1.
At Visit 1, prior to the administration of the capsule, concomitant medication, AEs and adhesion of patch should be checked. If there are violations of eligibility criteria the patient should be withdrawn from the study, the patch is to be removed and the patient is to be offered the site’s standard of anti emetic care.
If the patient’s chemotherapy is cancelled or delayed by more than one day, therefore the patch will have been applied more than 48 h before chemotherapy, the patient should be withdrawn from the study, the patch is to be removed and the patient is to be offered the site’s standard of anti emetic care.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified