Phase I Trial of Cisplatin and Pemetrexed in Combination With Panobinostat in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer
The purpose of this phase I study of oral panobinostat plus cisplatin and pemetrexed is to
determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) in patients
with advanced solid tumors, with an emphasis in non-small cell lung cancer. Another purpose
of this study is to find out if oral panobinostat in combination with cisplatin and
pemetrexed can be administered safely without significant increase in toxicity and that the
combination will increase efficacy compared to platinum-based doublet chemotherapy alone.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and feasibility of oral panobinostat in combination with cisplatin and pemetrexed
Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance of physical examination. Safety and tolerability will be assessed according to the NCI CTCAE v4.
Within ±3 days of the scheduled day of assessment except for adverse events that will be evaluated continuously through the study. The expected time frame for this outcome measure is 18 weeks (or six cycles)
Yes
David Gandara, MD
Principal Investigator
University of California, Davis
United States: Food and Drug Administration
UCDCC#220
NCT01336842
April 2011
December 2014
Name | Location |
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University of California Davis Cancer Center | Sacramento, California 95817 |