Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (Taxotere®) for Subjects With Advanced Cancer Tumors

PHASE1TerminatedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Breast CancerLung CancerPulmonary CancerNon-Small-Cell Lung CarcinomaProstate CancerProstatic CancerGastric CancerStomach Cancer
Interventions
DRUG

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."

Trial Locations (2)

19104

University of Pennsylvania, Philadelphia

21231

Johns Hopkins, Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors
All Listed Sponsors
lead

Mirati Therapeutics Inc.

INDUSTRY

NCT00511576 - Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (Taxotere®) for Subjects With Advanced Cancer Tumors | Biotech Hunter | Biotech Hunter