Status:
COMPLETED
Veliparib in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Pancreatic Cancer
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
AbbVie
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 Obj...
Detailed Description
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 G...
Eligibility Criteria
Inclusion
- Patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board.
- Age 18 years or older
Exclusion
- Patients who have had prior anti-cancer treatment for their disease
- Patients who are currently receiving any other investigational agents
- Metastatic disease
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PARP \[Poly (ADP-ribosome) polymerase\] inhibitors or gemcitabine
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
October 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01908478
Start Date
October 2 2013
End Date
July 6 2020
Last Update
July 15 2020
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048