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

Phase 2 Completed 55 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start: 2010-06
Primary completion: 2014-12
Completion: 2014-12

Outcome

Met primary endpoint

paper ORR was 26.2% (n = 11/42; 95% CI, 13.9%-42.0%), sufficient to reject the null hypothesis (ORR ≤10%). PMID 28327988 ↗

Publications

Guo J, Carvajal RD, Dummer R, Hauschild A, Daud A, Bastian BC, Markovic SN, Queirolo P, Arance A, Berking C, Camargo V, Herchenhorn D, Petrella TM, Schadendorf D, Sharfman W, Testori A, Novick S, Hertle S, Nourry C, Chen Q, Hodi FS. Efficacy and safety of nilotinib in patients with KIT-mutated metastatic or inoperable melanoma: final results from the global, single-arm, phase II TEAM trial. Ann Oncol. 2017 Jun 1;28(6):1380-1387. doi: 10.1093/annonc/mdx079.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dacarbazine	Small molecule	850 mg/m2	Intravenous
Subject	Nilotinib	Small molecule	400 mg	Oral