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
Interventional
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.
12-15 months
Yes
United States: Food and Drug Administration
CUDC-101-102
NCT01171924
July 2010
Name | Location |
---|---|
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 |