A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation (TEAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01028222
First received: December 7, 2009
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.


Condition Intervention Phase
Melanoma
Drug: nilotinib (AMN107)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Clinical efficacy of nilotinib based on overall response rate (ORR) [ Time Frame: study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Durable overall response rate (ORR) of patients treated with nilotinib [ Time Frame: study period ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) of patients treated with nilotinib [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Overall survival (OS) of patients treated with nilotinib [ Time Frame: study period ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: June 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMN107 (nilotinib) Drug: nilotinib (AMN107)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028222

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Hide Study Locations
Locations
United States, California
City of Hope National Medical Center City of Hope national Med Ctr Terminated
Duarte, California, United States, 91010-3000
University of California San Diego UCSD Moores Cancer Center Active, not recruiting
La Jolla, California, United States, 92093-0658
University of California at Los Angeles UCLA Terminated
Los Angeles, California, United States, 90024
University of California Irvine Dept of Hematology/Oncology Withdrawn
Orange, California, United States, 92868
California Pacific Medical Center California Pacific Med Active, not recruiting
San Francisco, California, United States, 94120-7999
University of California San Francisco UCSF Cancer & Leukima Group Withdrawn
San Francisco, California, United States, 94101
United States, Colorado
University of Colorado Univ Colorado 2 Terminated
Aurora, Colorado, United States, 80045
United States, Florida
Florida Hematology & Oncology Specialists FLHCI Withdrawn
Orlando, Florida, United States, 32804
United States, Illinois
Rush University Medical Center SC Completed
Chicago, Illinois, United States, 60612
Oncology Specialists, SC Dept.of Oncology Specialists Terminated
Park Ridge, Illinois, United States, 60068-0736
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Medical Oncology Completed
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute DFCI - Brookline Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic - Rochester Mayo Clinic- Gonda Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine Camn107B2301 Terminated
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute NVCC - Huntsman Withdrawn
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan Kettering Cancer Center Completed
New York, New York, United States, 10021
United States, North Carolina
Wake Forest University Baptist Medical Center Dept. of Industry Research (2) Withdrawn
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve Case Western Completed
Cleveland, Ohio, United States, 44106-5000
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio Univ/James Cancer Hosp Withdrawn
Columbus, Ohio, United States, 43210
United States, Pennsylvania
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2) Withdrawn
Bethlehem, Pennsylvania, United States
University of Pittsburgh Cancer Institute Dept of Hillman Cancer Center Withdrawn
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt University Medical Center SC Vanderbilt Withdrawn
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine Baylor 2 Terminated
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center Univ of Texas Southwestern Med Withdrawn
Dallas, Texas, United States, 75390-8527
United States, Utah
Huntsman Cancer Institute Univ. of Utah HCI Withdrawn
Salt Lake City, Utah, United States, 84112-0550
Argentina
Novartis Investigative Site Withdrawn
C A B A, Buenos Aires, Argentina, C1019ABS
Novartis Investigative Site Withdrawn
Santa Fe, Sante Fe, Argentina, S3000FFU
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1125ABE
Australia, New South Wales
Novartis Investigative Site Active, not recruiting
North Sydney, New South Wales, Australia, 2060
Australia, South Australia
Novartis Investigative Site Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Novartis Investigative Site Active, not recruiting
Heidelberg, Victoria, Australia, 3084
Novartis Investigative Site Active, not recruiting
Melbourne, Victoria, Australia, 3002
Belgium
Novartis Investigative Site Terminated
Bruxelles, Belgium, 1200
Novartis Investigative Site Active, not recruiting
Jette, Belgium, 1090
Novartis Investigative Site Active, not recruiting
Leuven, Belgium, 3000
Brazil
Novartis Investigative Site Withdrawn
Salvador, BA, Brazil, 41825-010
Novartis Investigative Site Withdrawn
Brasilia, DF, Brazil, 70840-901
Novartis Investigative Site Active, not recruiting
Belo Horizonte, MG, Brazil, 30150-281
Novartis Investigative Site Active, not recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Novartis Investigative Site Withdrawn
Caxias do Sul, RS, Brazil, 95070-560
Novartis Investigative Site Withdrawn
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site Completed
São Paulo, SP, Brazil, 01246-000
Canada, Alberta
Novartis Investigative Site Withdrawn
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site Active, not recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site Withdrawn
Montreal, Quebec, Canada, H2L 4M1
Canada
Novartis Investigative Site Withdrawn
Quebec, Canada, G1R 2J6
China
Novartis Investigative Site Active, not recruiting
Beijing, China, 100036
Germany
Novartis Investigative Site Withdrawn
Augsburg, Germany, 86156
Novartis Investigative Site Withdrawn
Berlin, Germany, 10098
Novartis Investigative Site Terminated
Erlangen, Germany, 91054
Novartis Investigative Site Completed
Essen, Germany, 45147
Novartis Investigative Site Withdrawn
Hannover, Germany, 30625
Novartis Investigative Site Withdrawn
Heidelberg, Germany, 69120
Novartis Investigative Site Withdrawn
Jena, Germany, 07740
Novartis Investigative Site Withdrawn
Kiel, Germany, 24105
Novartis Investigative Site Terminated
Köln, Germany, 50924
Novartis Investigative Site Withdrawn
Mainz, Germany, D-55101
Novartis Investigative Site Active, not recruiting
Muenchen, Germany, 80336
Novartis Investigative Site Completed
Tübingen, Germany, 72076
Italy
Novartis Investigative Site Withdrawn
Bari, BA, Italy, 70126
Novartis Investigative Site Active, not recruiting
Meldola, FC, Italy, 47014
Novartis Investigative Site Completed
Genova, GE, Italy, 16132
Novartis Investigative Site Withdrawn
Milano, MI, Italy, 20132
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Completed
Milano, MI, Italy, 20133
Novartis Investigative Site Terminated
Padova, PD, Italy, 35100
Novartis Investigative Site Withdrawn
Pisa, PI, Italy, 56126
Novartis Investigative Site Withdrawn
Faenza, RA, Italy, 48018
Novartis Investigative Site Withdrawn
Lugo, RA, Italy, 48022
Novartis Investigative Site Withdrawn
Ravenna, RA, Italy, 48100
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00167
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00128
Novartis Investigative Site Withdrawn
Rimini, RN, Italy, 47900
Novartis Investigative Site Active, not recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site Withdrawn
Candiolo, TO, Italy, 10060
Novartis Investigative Site Withdrawn
Napoli, Italy, 80131
Netherlands
Novartis Investigative Site Completed
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site Withdrawn
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site Completed
Nijmegen, Netherlands, 6525 GA
Poland
Novartis Investigative Site Withdrawn
Poznan, Poland, 61866
Novartis Investigative Site Withdrawn
Warszawa, Poland, 02-781
Singapore
Novartis Investigative Site Withdrawn
Singapore, Singapore, 169610
Spain
Novartis Investigative Site Completed
Barcelona, Cataluña, Spain, 08036
Novartis Investigative Site Active, not recruiting
Hospitalet de LLobregat, Cataluña, Spain, 08907
Novartis Investigative Site Withdrawn
Pamplona, Navarra, Spain, 31002
Sweden
Novartis Investigative Site Withdrawn
Goteborg, Sweden, SE-431 45
Novartis Investigative Site Withdrawn
Linköping, Sweden, SE-581 85
Novartis Investigative Site Active, not recruiting
Malmö, Sweden, SE-205 02
Novartis Investigative Site Completed
Stockholm, Sweden, SE-171 76
Novartis Investigative Site Withdrawn
Umeå, Sweden, SE-901 85
Novartis Investigative Site Withdrawn
Uppsala, Sweden, SE-751 85
Switzerland
Novartis Investigative Site Active, not recruiting
Zürich, Switzerland, 8091
Thailand
Novartis Investigative Site Terminated
Bangkok, Thailand, 10700
Novartis Investigative Site Withdrawn
Songkla, Thailand, 90110
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01028222     History of Changes
Other Study ID Numbers: CAMN107B2301, 2009-015514-21
Study First Received: December 7, 2009
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Institute for Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Ministry of Health
Singapore: Health Sciences Authority
Spain: Ministry of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
Thailand: Food and Drug Administration

Keywords provided by Novartis:
Melanoma
AMN107
c-Kit
c-Kit mutated metastatic and/or inoperable melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 16, 2014