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Clinical Trials/NL-OMON34305
NL-OMON34305
Completed
Phase 3

The TEAM trial (Tasigna efficacy in advanced melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna® versus dacarbazine (DTIC) in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation - The TEAM trial

ovartis0 sites7 target enrollmentTBD
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Conditionsdisseminated skin cancermetastatic melanoma10040900

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
disseminated skin cancer
Sponsor
ovartis
Enrollment
7
Status
Completed
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, acral or cutaneous melanoma.
  • •2\. Presence of a c\-Kit mutation of exon 11 or 13, or mutations Y822D and 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).
  • •5\. WHO performance status 0 \- 2\.
  • •6\. At least 28 days since major surgery and 7 days since skin/tumor biopsy until start of study drug.
  • •7\. Age 18 or greater.
  • •8\. Patients must have adequate bone marrow and organ function as defined by the following laboratory values:
  • •\* Biochemistry parameters within normal ranges prior to and at the latest by the day of first dosing, achieved by correction with supplements if necessary.
  • •\* ALT and AST \* 2\.5 x ULN (upper limit of normal) or \* 5\.0 x ULN if considered due to tumor.

Exclusion Criteria

  • •1\. C\-Kit mutation of exons 17(except mutations Y822D or Y823D) or 18\.
  • •2\. Patients with c\-Kit amplifications only and no mutation.
  • •3\. Patients with any NRAS or BRAF mutation
  • •4\. Patients with known untreated or treated brain metastases as shown at the screening visit or earlier (metastatic disease M1a, M1b, M1c are allowed).
  • •5\. Patients who have had any prior treatment with TKIs or DTIC.
  • •6\. Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit.
  • •7\. 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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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 mutatiodisseminated skin cancermetastatic melanoma10040900
NL-OMON37871ovartis3
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Tasigna efficacy in advanced melanomatreatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutationMedDRA version: 14.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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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. - The TEAM-trialtreatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutationMedDRA version: 17.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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The TEAM Trial (Tasigna Efficacy in Advanced Melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna ® versusdacarbazine (DTIC) in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation.
EUCTR2009-015514-21-BEovartis Pharma Services AG120
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The TEAM Trial (Tasigna Efficacy in Advanced Melanoma): A phase II,open label, multi-center, single-arm study to assess the efficacy ofTasigna ® in the treatment of patients with metastatic and/orinoperable melanoma harboring a c-Kit mutation.
EUCTR2009-015514-21-DEovartis Pharma Services AG41