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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.
Verified August 2011 by Novartis

First Received on December 7, 2009.   Last Updated on August 11, 2011   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT01028222
  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 II

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: 41
Study Start Date: April 2010
Estimated Primary Completion Date: January 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028222

Contacts
Contact: Novartis Pharmaceuticals +1-800 340 6843

  Show 81 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01028222     History of Changes
Other Study ID Numbers: CAMN107B2301, EUDRACT number: 2009-015514-21
Study First Received: December 7, 2009
Last Updated: August 11, 2011
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: State 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 February 09, 2012