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A Phase I Study of KU-0059436 Plus Gemcitabine in Patients with Advanced Pancreatic Cancer
[Protocol 09-073]
- Full Title :
- A PHASE I, OPEN-LABEL, STUDY OF THE SAFETY AND TOLERABILITY OF KU-0059436 IN COMBINATION WITH GEMCITABINE IN THE TREATMENT OF PATIENTS WITH ADVANCED SOLID TUMORS
- Purpose :
The purpose of this study is to evaluate the effectiveness of adding the investigational drug KU-0059436 to gemcitabine therapy in patients with advanced pancreatic cancer that has not yet been treated. KU-0059436 may make cancer cells more susceptible to the anticancer effects of gemcitabine by blocking a protein called PARP 1. It is a capsule that is taken orally.
Gemcitabine is a standard treatment for pancreatic cancer that is given intravenously. Patients in this study will be randomly assigned to receive gemcitabine alone or in combination with KU-0059436. Two-thirds of the patients will be allocated to the combination and one-third to gemcitabine alone.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have inoperable locally advanced or metastatic adenocarcinoma of the pancreas which has not yet been treated.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Eileen O'Reilly at 212-639-6672.
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