The main purpose of this study is to assess the safety profile of MGCD265 when administered in combination with the marketed anticancer drugs erlotinib and docetaxel.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
MGCD265 and erlotinib administered daily
MGCD265 administered daily; docetaxel administered once every 3 weeks
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Phase I: Safety profile (including maximum tolerated dose and dose limiting toxicities)
Time frame: 1 year
Phase II: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel
Time frame: 1 year
Phase I: Pharmacokinetic profiles of MGCD265+erlotinib and MGCD265+docetaxel
Time frame: 2 months
Phase I and Phase II: Pharmacodynamic profiles of MGCD265+erlotinib and MGCD265+docetaxel
Time frame: 1 year
Phase I: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel.
Time frame: 1 year
Phase II: Safety profile of MGCD265+erlotinib and MGCD265+docetaxel;
Time frame: 1 year
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South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States