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|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
- Drug: CUDC-101
Doses will be given by intravenous infusion over 1 hour on days 1-5 of each treatment cycle. Total treatment cycle duration will be 14 days. Additional treatment cycles will be administered until the subjects withdraws consent, experiences unacceptable toxicity, or if there is documented tumor progression.
- 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)|