Pancreatic Cancer Clinical Trial
Official title:
A Phase I Study of Veliparib (ABT-888) in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Locally Advanced, Unresectable Pancreatic Cancer
This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity
Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic
Cancer.
Primary Objectives:
- Determine the maximum tolerable dose of veliparib in combination with gemcitabine and
intensity modulated radiation therapy in patients with locally advanced pancreatic
cancer.
- Determine the safety and toxicity of the combination of veliparib with gemcitabine and
radiation therapy in patients with locally advanced pancreatic cancer
Gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on days 1, 8, 15 of the cycle. Intensity modulated radiation therapy (IMRT) will be given to a total dose of 36 Gy in 15 fractions (2.4 Gy per fraction, one fraction per day, 5 fractions per week, Monday through Friday) beginning on day 1. Veliparib will be administered per a dose escalation schema. The starting dose of veliparib is 20 mg BID based upon safety/efficacy data available. Dose escalation will continue in 20 mg increments until the maximum tolerated dose (MTD) is reached. Intra-patient dose escalation will not be allowed. ;
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