This is an open-label, multicenter, phase 1, dose escalation study that will evaluate the safety profile, establish Maximum Tolerated Dose (MTD), and inform the recommended phase 2 dose of MLN4924 as well as evaluate antitumor activity in patients with metastatic melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Patients will be administered MLN4924 via an IV infusion. Each 21-day treatment cycle is composed of 2 weeks intermittent dosing of MLN4924 on Days 1, 4, 8 and 11, followed by a rest period of 10 days. A cohort of patients will receive a reduced first dose on Day 1, approximately half the strength of the dose received on Days 4, 8, 11 and dose will not be administered on Day 4 if the Day 1 dose is not tolerated.(Schedule A ramp-up), or continuous weekly dosing (Days 1, 8, and 15) of MLN4924 (Schedule B)
The Angeles Clinic and Research Institute
Santa Monica, California, United States
Maximum Tolerated Dose (MTD) and inform recommended phase 2 dose of MLN4924
Time frame: Up to 12 months of treatment
Anti-tumor activities of MLN4924
Time frame: Up to 12 months of treatment
Pharmacodynamic effects of MLN4924 on blood and tumor cells
Time frame: Primarily assessed during the first cycle of therapy
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