A Phase Ib Open Label, Expansion Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the safety and tolerability of CUDC-101 in subjects with advanced solid tumors (breast, gastric, head and neck, liver, and non-small cell lung cancer) when administered at the MTD on either a 5 days/week schedule or 3 days/week schedule.
Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events, dose reductions, and patient compliance will be compared.
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of New Mexico Cancer Center||Albuquerque, New Mexico 87131-5636|
|The Angeles Clinic and Research Institute||Los Angeles, California 90025|
|Mary Crowley Cancer Research Centers||Dallas, Texas 75201|
|San Diego Pacific Oncology and Hematology Associates||Encinitas, California 92024|
|Mountain Blue Global Cancer Care||Wheat Ridge, Colorado 80033|