Gemcitabine + Cisplatin +/- Veliparib for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen ByEileen M O'Reilly

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well veliparib together with gemcitabine hydrochloride and cisplatin works compared to gemcitabine hydrochloride and cisplatin alone in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or spread from the primary site (place where it started) to other places in the body (metastatic). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving veliparib together with gemcitabine hydrochloride and cisplatin is an effective treatment for pancreatic cancer.

Eligibility Criteria

This trial is for adults with advanced or metastatic pancreatic cancer. Eligible participants include those who have not had prior treatment for advanced disease, or if they've had adjuvant therapy, it must be at least 6 months since completion. Participants need a confirmed BRCA1/2 or PALB2 mutation and should not be pregnant, as the drugs could harm the fetus. They must also agree to use contraception.

Inclusion Criteria

I have advanced pancreatic cancer with a confirmed BRCA or PALB2 mutation.

Your platelet count is at least 100,000 per microliter within 14 days before taking ABT-888.

Your total bilirubin levels should be within a certain range, as determined by the hospital, before starting the treatment.

+13 more

Exclusion Criteria

I have not had PARP inhibitor therapy and have had up to two prior cancer treatments.

Patients may not be receiving any other investigational agents

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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Participant Groups

The study tests whether adding Veliparib to standard chemotherapy (Gemcitabine Hydrochloride and Cisplatin) improves outcomes in patients with pancreatic cancer that has spread. Patients are randomly assigned to receive either the combination of all three drugs or just the chemotherapy alone.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (veliparib)Experimental Treatment4 Interventions

Patients receive veliparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout study. Patients also undergo tumor tissue and blood sample collection throughout the trial.

Group II: Arm A (veliparib, gemcitabine hydrochloride, cisplatin)Experimental Treatment8 Interventions

Patients receive veliparib PO BID on days 1-12 or 1-21 of each cycle. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 30 minutes on days 3 and 10 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout study. Patients also undergo tumor tissue and blood sample collection throughout the trial and undergo tumor biopsy during screening and on study.

Group III: Arm B (gemcitabine hydrochloride, cisplatin)Active Control7 Interventions

Patients receive gemcitabine hydrochloride IV and cisplatin IV as patients in arm A. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout study. Patients also undergo tumor tissue and blood sample collection throughout the trial and undergo tumor biopsy during screening and on study.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: