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| 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 |
| 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 |
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:
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations| Contact: Novartis Pharmaceuticals | +1-800 340 6843 |
Show 81 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| 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 |
|
Melanoma AMN107 c-Kit c-Kit mutated metastatic and/or inoperable melanoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |