This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.
This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined: Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
CUDC-907 oral with meals.
UCSF School of Medicine
San Francisco, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors
Time frame: 21 day cycle
To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).
Time frame: 21 day cycle
To evaluate biomarkers of CUDC-907 activity
Time frame: 24 months
To assess the preliminary anti-cancer activity of CUDC-907
The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type
Time frame: 24 months
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