A Phase 1B/2A, Open-label, Non-randomized, Multi-arm Study of TL32711 in Combination With Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors
The purpose of this study is to determine the safety and maximum tolerated dose of TL32711
as a 30 minute intravenous infusion once a week, for 2 consecutive weeks, when combined with
standard regimens of chemotherapy in subjects with advanced or metastatic solid tumors.
Additionally the study will assess anti-tumor activity, pharmacokinetics, and exploratory
biomarkers as a measurement of pharmacodynamic effects.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of subjects with adverse events as a measure of safety and tolerability
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
1 Cycle (3-4 weeks)
Yes
Neil N Senzer, MD
Principal Investigator
Mary Crowley Medical Research Center
United States: Food and Drug Administration
TL32711-POC-0078-PTL
NCT01188499
October 2010
December 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
University of Pennsylvania Abramson Cancer Center | Philadelphia, Pennsylvania 19104 |
South Texas Accelerated Research Therapeutics (START) | San Antonio, Texas 78229 |
Barbara Ann Karmanos Cancer Center | Detroit, Michigan 48201 |