23
Participants
Start Date
October 31, 2007
Primary Completion Date
March 31, 2009
Study Completion Date
March 31, 2009
MGCD0103 and Azacitidine
"In Part 1 of the study, up to 22 people to enroll will receive a single, oral dose (75 mg gelcap) of MGCD0103 and FB-MGCD0103 during their first 2 weeks in the study. Up to 22 additional people will receive a single dose of both MGCD0103 and TA-FB-MGCE0103. The next group of people to enroll will receive 2 different single doses (25, 50, 100 mg) of FB-MGCD0103 or TA-FB-MGCD0103 during their first 2 weeks in the study.~In Part 2 of the study, from Day 1-5 of each 28-day cycle, all subjects will receive a dose of azacitidine (75 mg/m2) either subcutaneously or through an intravenous device, and on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, a single, oral dose (85 mg) of MGCD0103 until progression or unacceptable toxicity develops."
St. Francis Cancer Research Foundation, Beech Grove
University of Texas, MD Anderson, Houston
Nevada Cancer Institute, Las Vegas
Weill Medical College of Cornell University, New York
Lead Sponsor
Mirati Therapeutics Inc.
INDUSTRY