University of Virginia
The goal of this study is to find out if taking two oral study drugs (avutometinib and defactinib) are safe for patients with pancreatic ductal adenocarcinoma (PDAC). Researchers also want to see if the drugs can slow down tumor growth and shrink tumors for possible surgery. These drugs are approved by the FDA to treat a certain kind of ovarian cancer. This study has two parts: * Part A is for patients whose cancer has spread to other parts of the body. * Part B is for patients whose cancer has not spread, but who cannot have surgery. Participants will take both drugs as told by their doctor with their regular cancer medicine. Participants will also give blood samples throughout the study. These samples will help researchers learn about how participants respond to treatment and about their pancreatic cancer.
Participants in part A will take the study drugs in 28-day cycles for up to 6 cycles with their chemotherapy. Participants whose cancer is not getting worse (known as disease control) may continue the study drugs in combination with maintenance chemotherapy until their disease worsens or negative side effects are noted. Participants in part B will take the study drugs in 28-day cycles for up to 6 cycles with their chemotherapy. After cycle 4 and cycle 6, participants will have their disease re-assessed with consideration for surgery. Participants whose cancer is not getting worse (disease con…
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Individuals ≥ 18 years of age. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Ability to take oral medication and be willing to adhere to the study intervention regimen. 5. Ability to receive mFOLFIRINOX. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Adenocarcinoma of the pancreas, confirmed by histology or cytology. 1. Part A: Metastatic pancreatic cancer 2. Part B: Borderline resectable or locally advanced PDAC not e…
Participants will receive avutometinib and defactinib in combination with mFOLFIRINOX (standard of care chemotherapy) in 28-day cycles for up to 6 cycles.
Arctuva estimate
Verify or correct the compensation shown for this listing.