Active not recruitingPHASE2INTERVENTIONAL

Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

This research is investigating treatments for pancreatic cancer that has either grown into nearby tissues or spread to other parts of the body. The study aims to see if adding a new drug called veliparib to standard chemotherapy (gemcitabine and cisplatin) is more effective than chemotherapy alone. Veliparib works by blocking certain things cancer cells need to grow. We're particularly interested in people who have specific genetic changes (in BRCA or PALB2 genes). The study also looks at veliparib on its own for those whose cancer has been treated before. By comparing these treatments, we hope to find better ways to fight pancreatic cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

National Cancer Institute (NCI)

Enrolment target

Start

15 May 2012

Estimated completion

09 Mar 2027

Locally Advanced Pancreatic Adenocarcinoma Metastatic Pancreatic Adenocarcinoma Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8

Results

Results from this study

Posted May 2026

Results have been published for this study.

Primary outcome

Optimal Dose of Veliparib With Gemcitabine Hydrochloride and Cisplatin (Non-randomized Part I)

There will be a small lead-in, non-randomized portion to Part I, where dose levels of veliparib 20 mg po BID (dose level 0), 40 mg po BID (dose level 1) and 80 mg po BID (dose level 2), will be evaluated on a day 1-12 schedule. The doses of gemcitabine 600 mg/m2 and cisplatin 25 mg/m2 are fixed. Three-6 patients will be evaluated per dose level starting with 20 mg po BID (dose level 0). If no dose-limiting toxicity (DLT), the dose of veliparib will be increased to 40 mg po BID (dose level 1) and subsequently to 80 mg po BID (dose level 2). If no DLT is observed at the veliparib dose of 80 mg BID day 1-12, then dose level 2A will examine veliparib at 80 mg po BID day 1-21, i.e., continuous dosing of veliparib.

Full results on the registry

What is this study about?

This study is designed to find better ways to treat pancreatic cancer, especially when it has grown into nearby tissues (locally advanced) or spread to other parts of the body (metastatic). Currently, a common treatment is chemotherapy using two drugs: gemcitabine and cisplatin. This study is testing a new drug called veliparib alongside this standard chemotherapy.

Veliparib is a type of drug that might help stop cancer cells from growing by interfering with processes they need to survive. Chemotherapy drugs like gemcitabine and cisplatin work in different ways to kill cancer cells, stop them from dividing, or prevent them from spreading. Researchers want to know if combining veliparib with gemcitabine and cisplatin is a more effective treatment option for pancreatic cancer than chemotherapy alone. They are particularly interested in patients who have specific changes in their BRCA or PALB2 genes, as these changes might make the new drug more effective.

The study is divided into parts. One part compares the combined treatment (veliparib plus chemotherapy) with chemotherapy alone. Another part looks at veliparib by itself for patients whose cancer has been treated before. By carefully studying how these treatments work, their side effects, and how patients respond, the aim is to improve future treatments for pancreatic cancer.

Key takeaways

This study evaluates new treatments for advanced pancreatic cancer.
It tests veliparib, a new drug, with or without standard chemotherapy.
People with specific BRCA or PALB2 gene changes are key to this study.
Participation involves biopsies, scans, blood tests, and regular clinic visits.
The goal is to find more effective ways to treat this type of cancer.

Who may be eligible?

This study is for adults over 18 who have pancreatic cancer that is either locally advanced (grown into nearby tissues) or has spread to other parts of the body. A key requirement is that you must have a specific change in your BRCA1, BRCA2, or PALB2 genes. These gene changes will be checked by a special test.

If you haven't received any treatment for your advanced pancreatic cancer yet, you might be able to join the main comparison part of the study. However, any previous treatment must have been for earlier-stage cancer, and your cancer must have come back at least six months after that treatment ended.

If your pancreatic cancer has been treated before, you might be able to join the part of the study that looks at veliparib on its own. You could have had up to two previous treatments, as long as it wasn't a similar type of drug to veliparib, and you finished your last treatment at least three weeks before starting this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Do you have pancreatic cancer that is locally advanced or has spread?
Do you know if you have a change in your BRCA1, BRCA2, or PALB2 genes?
Have you not had any prior treatment for your advanced pancreatic cancer (or if you did, it was for earlier-stage cancer and recurred after 6 months)?
If your cancer has been treated before, have you had no more than two previous treatments and not a similar drug to veliparib, and finished your last treatment at least 3 weeks ago?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several steps. You will have a biopsy (a small tissue sample taken) and blood samples collected for testing before treatment starts. You'll also have scans like CT or MRI to check the cancer. Depending on which group you are in, you will receive chemotherapy drugs (gemcitabine and cisplatin) with or without veliparib, or veliparib alone. All treatments are given under careful medical supervision.

The study involves regular visits to the clinic for treatment and to monitor your health and how well the treatment is working. This will include more scans and blood tests. The exact number of visits and tests will depend on your individual treatment plan and how you respond. The doctors will also assess any side effects you might experience. We don't have a set total duration for all participants, as it often depends on how the treatment is working and your overall health, but you will be monitored throughout the treatment and for a period afterwards.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to new treatments that aren't yet widely available, and these treatments might be more effective for your cancer. However, like all medical treatments, there are potential risks, including side effects from the medications. The research team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

University of Chicago Comprehensive Cancer Center
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Chicago, United States
Ingalls Memorial Hospital
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Harvey, United States
University of Michigan Rogel Cancer Center
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Ann Arbor, United States
Mercy Hospital Saint Louis
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St Louis, United States
Memorial Sloan Kettering Basking Ridge
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Basking Ridge, United States
Memorial Sloan Kettering Commack
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Commack, United States
Memorial Sloan Kettering Westchester
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Harrison, United States
Memorial Sloan Kettering Cancer Center
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New York, United States
Memorial Sloan Kettering Nassau
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Uniondale, United States
University Health Network-Princess Margaret Hospital
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Toronto, Canada
Shaare Zedek Medical Center
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Jerusalem, Israel
Chaim Sheba Medical Center
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Tel Litwinsky, Israel

Common questions

What is pancreatic cancer?

Pancreatic cancer starts in the pancreas, an organ that helps with digestion and making hormones. It can be challenging to treat, especially if it's spread.

What are BRCA and PALB2 genes?

These are genes involved in repairing damaged DNA. Changes in these genes can sometimes increase the risk of certain cancers, including pancreatic cancer.

What is chemotherapy?

Chemotherapy uses medicines to kill cancer cells or stop them from growing. Gemcitabine and cisplatin are common chemotherapy drugs for pancreatic cancer.

What is veliparib?

Veliparib is an investigational drug that may help fight cancer by blocking certain enzymes that cancer cells need to repair themselves and grow.

Is this a new treatment?

Yes, veliparib in combination with gemcitabine and cisplatin is being studied to see if it's an effective new treatment for pancreatic cancer.