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Clinical Trials/NL-OMON37871
NL-OMON37871
Withdrawn
Phase 2

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 (am2)

ovartis0 sites3 target enrollmentTBD
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Conditionsdisseminated skin cancermetastatic melanoma10040900

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
disseminated skin cancer
Sponsor
ovartis
Enrollment
3
Status
Withdrawn
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
ovartis

Eligibility Criteria

Inclusion Criteria

  • •1\. Histologically confirmed mucosal or acral
  • •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 straing 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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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