This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
San Diego Pacific Oncology and Hematology Associates
Encinitas, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Mountain Blue Global Cancer Care
Wheat Ridge, Colorado, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Number of Participants With Adverse Events
Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.
Time frame: 12-15 months
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