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.