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Brief Title: Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors
Official Title: Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors
Study ID: NCT02307240
Brief Summary: 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.
Detailed Description: 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).
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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