NCT01908478
Completed
Phase 1
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
ConditionsPancreatic Cancer
Overview
- Phase
- Phase 1
- Intervention
- Intensity modulated radiation therapy
- Conditions
- Pancreatic Cancer
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Maximum-tolerated dose (MTD) of veliparib based on the incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 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
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 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.
Investigators
Richard Tuli, MD
Assistant Professor, Radiation Oncology
Cedars-Sinai Medical Center
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Combination: veliparib, gemcitabine, and IMRT
Intervention: Intensity modulated radiation therapy
Combination: veliparib, gemcitabine, and IMRT
Intervention: Veliparib
Combination: veliparib, gemcitabine, and IMRT
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Maximum-tolerated dose (MTD) of veliparib based on the incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Time Frame: Days 1-70
Secondary Outcomes
- Assessment of objective response rates measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(From baseline to Week 26)
- Evaluation of pre-treatment biopsy specimens for levels of various DNA repair proteins(Baseline only)
- Change in PAR [Poly(ADP-ribosyl)ation] levels in peripheral blood mononuclear cells(Baseline, Weekly for 6 weeks, and at Weeks 10, 18, and 26)
Study Sites (1)
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