A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of CUDC-101 in Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00728793|
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tumors||Drug: CUDC-101||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Open-Label, Multiple Dose, Sequential Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced and Refractory Solid Tumors|
|Study Start Date :||August 2008|
|Primary Completion Date :||April 2010|
|Study Completion Date :||April 2010|
- The highest dose level of CUDC-101 at which <33% of at least 6 or more subjects experiences a dose limiting toxicity. [ Time Frame: Study treatment period - approximately 12 months ]The maximum tolerated dose is the highest dose level at which <33% of at least 6 or more subjects experiences a dose limiting toxicity.
- The number of patients with adverse events. [ Time Frame: Study treatment period - approximately 12 months ]The number of patients with adverse events will be assessed to determine the safety and tolerability of CUDC-101.
- Number of patients that show a response (complete response or partial response) based on RECIST criteria. [ Time Frame: Study treatment period - approximately 12 months ]To evaluate the efficacy of CUDC-101 in subjects with advanced and refractory solid tumors, responses based on RECIST criteria will be evaluated.
- Plasma concentration of CUDC-101 over time from Day 1 through Day 6. [ Time Frame: Approximately 1 week ]To assess the pharmacokinetics of CUDC-101 in this patient population, plasma concentration of CUDC-101 will be measured over time from Day 1 through Day 6.
- Measurement of epidermal growth factor receptor (EGFR) in archival tumor tissue, skin biopsies and tumor biopsies. [ Time Frame: Pre-treatment through Day 5 of cycle 1 - approximately 1 week ]Measurement of EGFR to evaluate pharmacodynamic biomarkers of CUDC-101 activity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728793
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Texas|
|START (South Texas Accelerated Research Therapeutics)|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Anthony Tolcher, M.D.||START (South Texas Accelerated Research Therapeutics)|