Conditions: Melanoma
Keywords: Melanoma AMN107 c-Kit c-Kit mutated metastatic and/or inoperable melanoma
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

Brief 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.

Detailed description:
This trial began as a multi-center, randomized, Phase III, controlled trial for nilotinib vs (DTIC) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-Kit mutated metastatic and/or inoperable melanoma. The study was open to patients with mucosal or acral melanoma.

Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study with protocol Amendment 2 (27-Jul-2011). While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to dacarbazine ( DTIC ) DTIC were not). Patients randomized to DTIC were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Arms:
arm 1: 400 mg twice daily arm 2: 850 mg/m2 IV every 3 weeks

Interventions: intervention 1: Nilotinib intervention 2: DTIC
Intervention descriptions: intervention 1: Nilotinib was provided as 200 mg hard gelatin capsules for oral use. intervention 2: DTIC was supplied locally as sterile powder for i.v. infusion.

Protocol document: