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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


Inclusion Criteria:



1. Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11
or 13, or mutations Y822D and mutations D820Y, 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 1.0. 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

Exclusion Criteria:

1. C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon
not allowed by the inclusion criteria

2. Patients with c-Kit amplifications only and no mutation

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

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Clinical efficacy of nilotinib based on overall response rate (ORR)

Outcome Time Frame:

study period

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107B2301

NCT ID:

NCT01028222

Start Date:

June 2010

Completion Date:

March 2013

Related Keywords:

  • Melanoma
  • Melanoma
  • AMN107
  • c-Kit
  • c-Kit mutated metastatic and/or inoperable melanoma
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Medical OncologyBaltimore, Maryland  21231
University of Pittsburgh Cancer Institute Dept of Hillman Cancer CenterPittsburgh, Pennsylvania  15232
UCLA/ University of California Los Angeles UCLALos Angeles, California  90095
California Pacific Medical Center California Pacific MedSan Francisco, California  94120-7999
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2)Bethlehem, Pennsylvania  
Rush University Medical Center SCChicago, Illinois  60612
Dana Farber Cancer Institute DFCI - BrooklineBoston, Massachusetts  02115
Nevada Cancer Institute NVCC - HuntsmanLas Vegas, Nevada  89135
Wake Forest University Baptist Medical Center Dept. of Industry Research (2)Winston-Salem, North Carolina  27157
City of Hope National Medical Center City of Hope national Med CtrDuarte, California  91010-3000
University of California San Diego UCSD Moores Cancer CenterLa Jolla, California  92093-0658
University of California Irvine Dept of Hematology/OncologyOrange, California  92868
University of California San Francisco UCSF Cancer & Leukima GroupSan Francisco, California  94101
University of Colorado Univ Colorado 2Aurora, Colorado  80045
Florida Hematology & Oncology Specialists FLHCIOrlando, Florida  32804
Oncology Specialists, SC Dept.of Oncology SpecialistsPark Ridge, Illinois  60068-0736
Mayo Clinic - Rochester Mayo Clinic- GondaRochester, Minnesota  55905
Washington University School of Medicine Camn107B2301St. Louis, Missouri  63110
Case Western Reserve Case WesternCleveland, Ohio  44106-5000
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio Univ/James Cancer HospColumbus, Ohio  43210
Vanderbilt University Medical Center SC VanderbiltNashville, Tennessee  37232
Baylor College of Medicine Baylor 2Dallas, Texas  75246
University of Texas Southwestern Medical Center Univ of Texas Southwestern MedDallas, Texas  75390-8527
Huntsman Cancer Institute Univ. of Utah HCISalt Lake City, Utah  84112-0550