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.
Provision of signed and dated informed consent form.
Individuals ≥ 18 years of age.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Ability to take oral medication and be willing to adhere to the study intervention regimen.
Patients with pancreatic neuroendocrine tumors (PNET), islet cell tumors, mucinous cystic, acinar or squamous (≥ 50%) histology are excluded.
Prior treatment for pancreatic ductal adenocarcinoma.
Presence of distant metastases (Part B only).
Presence of symptomatic ascites or the need for paracentesis within 2 weeks prior to registration.
Sequential
Avutometinib (VS-6766) + Defactinib (VS-6063)
DrugParticipants will receive avutometinib and defactinib in combination with mFOLFIRINOX (standard of care chemotherapy) in 28-day cycles for up to 6 cycles.
Dose limiting toxicities (DLTs) - Part A
For each participant, we will determine DLTs during first cycle of neoadjuvant therapy
Objective response (OR) - Part B
PR (partial response) or CR (complete response) per RECIST criteria
TRAEs (Treatment-related adverse events)
Cumulative incidence of adverse events as defined by CTCAE v5 tabulating frequency, proportion, and severity
(Part B only): Surgical resection rate
We will determine the number of participants eligible for surgical resection out the total number of study participants.
EFS (event free-survival)
disease progression, disease recurrence after surgery, or death
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
Verastem, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
