A Phase Ib Expansion Study Investigating 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
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.
Head and Neck Cancer
Non-Small Cell Lung Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 12-15 months ] [ Designated as safety issue: Yes ]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.
- To evaluate the efficacy of CUDC-101 in subjects with advanced and refractory solid tumors. [ Time Frame: 12-15 months ] [ Designated as safety issue: No ]Efficacy will be assessed using standard RECIST Criteria and the response rate and duration of responses will be compared between the two treatment arms.
- To assess the pharmacokinetics of CUDC-101 in this patient population. [ Time Frame: 12-15 months ] [ Designated as safety issue: No ]Concentrations of CUDC-101 in blood and urine samples following CUDC-101 administration will be assessed and compared between the two treatment arms.
- To evaluate pharmacodynamic biomarkers of CUDC-101 activity. [ Time Frame: 12-15 months ] [ Designated as safety issue: No ]The ability of CUDC-101 to modulate key target proteins including EGFR, HER2 and HDAC will be assessed in tumor biopsies and peripheral circulating cells.
|Study Start Date:||July 2010|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Arm A: 5 days/week schedule||
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.
|Experimental: Arm B: 3 days/week schedule||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171924
|United States, California|
|San Diego Pacific Oncology and Hematology Associates|
|Encinitas, California, United States, 92024|
|The Angeles Clinic and Research Institute|
|Los Angeles, California, United States, 90025|
|United States, Colorado|
|Mountain Blue Global Cancer Care|
|Wheat Ridge, Colorado, United States, 80033|
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Texas|
|Mary Crowley Cancer Research Centers|
|Dallas, Texas, United States, 75230|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|