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

Completed · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT01028222

Run by

Novartis Pharmaceuticals

People needed

55

Starts

2010-06-01

Expected to finish

2014-12-01

Last updated by the study team

2015-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria
• Patients with c-Kit amplifications only and no mutation
• Patients with any history of brain metastases
• Patients who have had any prior treatment with TKIs
• Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit
• Acute or chronic liver or renal disease considered unrelated to melanoma
• Other protocol-defined inclusion/exclusion criteria may have applied.

Where it is running

• City of Hope National Medical Center City of Hope national Med Ctr — Duarte, California, United States
• University of California San Diego - Moores Cancer Center UCSD Moores Cancer Center — La Jolla, California, United States
• University of California at Los Angeles UCLA — Los Angeles, California, United States
• California Pacific Medical Center California Pacific Med — San Francisco, California, United States
• University of Colorado Univ Colorado 2 — Aurora, Colorado, United States
• Rush University Medical Center SC — Chicago, Illinois, United States
• Oncology Specialists, SC Dept.of Oncology Specialists — Park Ridge, Illinois, United States
• Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Medical Oncology — Baltimore, Maryland, United States
• Dana Farber Cancer Institute DFCI - Brookline — Boston, Massachusetts, United States
• Mayo Clinic - Rochester Mayo Clinic- Gonda — Rochester, Minnesota, United States
• Washington University School of Medicine CAMN107B2301 — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Case Western Reserve Case Western — Cleveland, Ohio, United States
• Baylor Health Care System/Sammons Cancer Center Baylor 2 — Dallas, Texas, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — North Sydney, New South Wales, Australia
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — East Melbourne, Victoria, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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