Two Phase II Studies of Veliparib for Pancreatic Cancer with a BRCA or PALB2 Mutation: Gemcitabine...

Protocol
12-045
Full Title
A Randomized Phase II Study of Gemcitabine, Cisplatin +/- Veliparib in Patients with Pancreas Adenocarcinoma and a Known BRCA/ PALB2 Mutation (Part I) and a Phase II Single Arm Study of Single-Agent Veliparib in Previously Treated Pancreas Adenocarcinoma (Part II)(NCI #8993)
Phase
II
Purpose

Gemcitabine and cisplatin are anticancer drugs commonly used to treat pancreatic cancer. However, in many cases the tumor develops resistance to this treatment. This clinical trial involves two studies. The purpose of the first study (Part I) is to assess the safety and effectiveness of adding the investigational drug veliparib to treatment with gemcitabine and cisplatin in patients with untreated pancreatic cancers that contain BRCA and PALB2 mutations. The purpose of the second study (Part II) is to assess the safety and effectiveness of veliparib alone in patients with previously treated pancreatic cancer.

Veliparib (also known as ABT-888) kills cancer cells by blocking a protein called PARP, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more susceptible to anticancer drugs. It can also work well in cancer cells that do not have functional BRCA or PALB2, proteins which help to fix DNA damage. Veliparib is a pill that is taken orally (by mouth).

In Part I, patients with untreated pancreatic cancer and BRCA and/or PALB2 mutations will be randomly assigned to receive gemcitabine and cisplatin with or without veliparib. In Part II, patients with previously treated pancreatic cancer that continues to grow despite prior therapy will receive veliparib alone. Patients from Part I whose cancer did not respond to gemcitabine and cisplatin treatment alone may be eligible to participate in Part II.

Eligibility

To be eligible for these studies, patients must meet several criteria, including but not limited to the following:

For Part I:

  • Patients must have locally advanced or metastatic (stage III or IV) pancreatic cancer that contains a BRCA or PALB2 mutation.
  • Patients may not have had prior therapy for locally advanced or metastatic disease. Prior adjuvant gemcitabine or a fluoropyrimidine is permitted if it was completed more than 6 months before disease recurrence.
  • Patients may not have previously received a PARP inhibitor.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For Part II (veliparib alone)

  • Patients must have locally advanced or metastatic (stage III or IV) pancreatic cancer that progressed despite at least two prior regimens of chemotherapy.
  • At least 3 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients may not have previously received a PARP inhibitor.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about these studies and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.

Disease(s)
Hepatobiliary: Pancreatic Cancer
Upper Gastrointestinal: Pancreatic Cancer
Locations
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