Chemotherapy + Veliparib for Pancreatic Cancer

This trial tests a combination of chemotherapy drugs with veliparib to determine if it is more effective than chemotherapy alone for treating pancreatic cancer that has returned after treatment. The goal is to discover if adding veliparib, which may block enzymes that aid tumor cell growth, improves patient outcomes. Participants should have metastatic pancreatic cancer that has recurred after one treatment and should not have received irinotecan-based chemotherapy or certain other drugs previously. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not have received prior irinotecan-based chemotherapy or PARP inhibitor therapy. It's best to discuss your current medications with the trial team.

A previous study found that combining veliparib with FOLFIRI did not present any unexpected safety issues for patients with pancreatic cancer, indicating no surprising or severe side effects. Veliparib, when used with treatments like gemcitabine and radiation, was generally well-tolerated, meaning most patients managed it without serious problems.

Research has shown that side effects are common with fluorouracil. About 70.8% of patients experienced some side effects, with around 27.2% facing serious ones, such as a drop in white blood cells (neutropenia). However, these effects are often manageable.

Irinotecan hydrochloride has been associated with serious outcomes, including hospitalizations and, in some cases, deaths. Despite this, when combined with other drugs, it has demonstrated an acceptable safety profile, meaning the benefits can outweigh the risks for many patients.

Researchers are excited about the combination treatment involving veliparib for pancreatic cancer because it offers a new approach by incorporating a PARP inhibitor. Unlike the standard of care, which typically includes chemotherapy regimens like FOLFIRI, this treatment adds veliparib, which targets cancer cells' DNA repair mechanisms, potentially enhancing the effects of chemotherapy. This dual action could lead to more effective cancer cell destruction and improved outcomes for patients. Additionally, the innovative use of veliparib could provide benefits for individuals who have limited options with traditional treatments alone.

Research shows that veliparib, one of the treatments in this trial, may help treat pancreatic cancer when combined with other treatments. In one study, patients with advanced pancreatic cancer who took veliparib lived slightly longer. Some patients had their disease remain stable for 14% of the time, with a few experiencing benefits for up to 25 months. Veliparib blocks certain enzymes that help cancer cells grow. In this trial, one group of participants will receive a chemotherapy mix called FOLFIRI, which stops tumors by killing or stopping cancer cells from dividing. Another group will receive FOLFIRI combined with veliparib. The trial aims to determine if adding veliparib to FOLFIRI increases its effectiveness against recurrent pancreatic cancer.⁶⁷⁸⁹¹⁰