The TEAM Trial (Tasigna Efficacy in Advanced Melanoma): A phase II, open label, multi-center, single-arm study to assess the efficacy of Tasigna ® in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation. - TEAM

ovartis Pharma Services AG0 sites55 target enrollmentJune 24, 2010

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation
Sponsor: ovartis Pharma Services AG
Enrollment: 55
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

June 24, 2010

End Date

December 31, 2014

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Histologically confirmed mucosal or acral melanoma.
•2\.Presence of a c\-Kit mutation of exon 9, 11 or 13, or mutations D820G, N822H, N822K, D820Y, Y822D or Y823D of exon 17, as confirmed by the central laboratory.
•3\.Stage III unresectable or stage IV disease.
•4\.The presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to RECIST. Lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm) or double the slice thickness to be considered a target lesion. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression.
•5\.WHO performance status 0 \- 2\.
•6\.At least 28 days since major surgery prior to starting study drug.
•7\.Age 18 or greater.
•8\.Patients must have adequate bone marrow and organ function as defined by the following laboratory values:
•Serum potassium within the normal limits or corrected to within normal limits with supplements
•Total calcium (corrected for serum albumin) within the normal limits or corrected to within normal limits with supplements

•1\.C\-Kit mutation of exons 17 (except mutations D820G, N822H, N822K, D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria.
•2\.Patients with c\-Kit amplifications without mutations.
•3\.Patients with any history of brain metastases.
•4\.Patients who have had any prior treatment with TKIs.
•5\.Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit.
•6\.Impaired cardiac function, including any one of the following:
•LVEF \< 45% or below institutional lower limit of the normal range (which ever is higher) as determined by MUGA scan or echocardiogram.
•Complete left bundle branch block.
•Use of a cardiac pacemaker.
•Congenital long QT syndrome.