Veliparib In Combination With Gemcitabine And Intensity Modulated Radiation Therapy In Patients With Pancreatic Cancer

Study Overview

Veliparib in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With 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.

Pancreatic Cancer

DRUG: Veliparib
DRUG: Gemcitabine
RADIATION: Intensity modulated radiation therapy

IIS-ABT888-0002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-07-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-07-13
First Submitted that Met QC Criteria 2013-07-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-07-15
First Posted (ACTUAL) 2013-07-25	Results First Posted N/A	Last Verified 2020-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Combination: veliparib, gemcitabine, and IMRT	DRUG: Veliparib DRUG: Gemcitabine RADIATION: Intensity modulated radiation therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Combination: veliparib, gemcitabine, and IMRT

DRUG: Veliparib

DRUG: Gemcitabine

RADIATION: Intensity modulated radiation therapy

Primary Outcome Measures	Measure Description	Time Frame
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)		Days 1-70

Secondary Outcome Measures	Measure Description	Time Frame
Assessment of objective response rates measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

AbbVie

Investigators

PRINCIPAL_INVESTIGATOR: Richard Tuli, MD, Cedars-Sinai Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record