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

December 7, 2009
August 13, 2014
June 2010
October 2014   (final data collection date for primary outcome measure)
Clinical efficacy of nilotinib based on overall response rate (ORR) [ Time Frame: study period ] [ Designated as safety issue: No ]
To compare the clinical efficacy of nilotinib to DTIC based on progression free survival (PFS). [ Time Frame: Every 3 weeks until week 12, then every 6 weeks until week 24, then every 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01028222 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To compare objective overall response rate (ORR) between nilotinib and DTIC. [ Time Frame: Every 3 weeks until week 12, then every 6 weeks until week 24, then every 12 weeks ] [ Designated as safety issue: No ]
  • To compare durable objective response rate (DORR) between nilotinib and DTIC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To compare overall survival (OS) between nilotinib and DTIC [ Time Frame: Every 3 weeks until week 12, then every 6 weeks until week 24, then every 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation
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 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Melanoma
Drug: nilotinib (AMN107)
Experimental: AMN107 (nilotinib)
Intervention: Drug: nilotinib (AMN107)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
51
October 2014
October 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Germany,   Netherlands,   Thailand,   Switzerland,   Sweden,   Spain,   Singapore,   Poland,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Italy
 
NCT01028222
CAMN107B2301, 2009-015514-21
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP