Dose Escalation Study of MLN4924 in Adults With Melanoma

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

May 31, 2012

Study Completion Date

January 31, 2013

Conditions
Metastatic Melanoma
Interventions
DRUG

MLN4924

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)

Trial Locations (1)

90404

The Angeles Clinic and Research Institute, Santa Monica

All Listed Sponsors
lead

Millennium Pharmaceuticals, Inc.

INDUSTRY

NCT01011530 - Dose Escalation Study of MLN4924 in Adults With Melanoma | Biotech Hunter | Biotech Hunter