54
Participants
Start Date
August 31, 2007
Primary Completion Date
March 31, 2009
Study Completion Date
March 31, 2009
MGCD0103 & Docetaxel
"In both Parts 1 and 2, subsequent doses of MGCD0103 will be escalated in 25 mg increments until the MTD of MGCD0103 in combination with each fixed dose (60 mg/m2 or 75 mg/m2) ofIV docetaxel is determined.~In both parts 1 and 2, MGCD0103 will be administered orally TIW for 3 weeks beginning on Day 1 at 1 hour prior to the start of the IV docetaxel infusion.~There will be no scheduled break between cycles and no limit to the number of cycles a subject can receive provided they do not have disease progression as defined by RECIST, or a clinically significant drug-related adverse event (AE) that does not resolve or respond to treatment intervention with 3 weeks."
University of Pennsylvania, Philadelphia
Johns Hopkins, Sidney Kimmel Comprehensive Cancer Center, Baltimore
Lead Sponsor
Mirati Therapeutics Inc.
INDUSTRY