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Avutometinib + Defactinib for Pancreatic Cancer

(Panc 004 Trial)

AN
KH
Overseen ByKristen Harris
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MR

Matthew Reilley, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for people with pancreatic ductal adenocarcinoma. It includes those whose cancer has spread or those who can't have surgery, as long as they are able to take oral medications and follow study instructions.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study
Radiographically measurable disease of at least one site by CT or MR imaging as defined by RECIST 1.1
I have not received any treatment for my pancreatic cancer.
See 10 more

Exclusion Criteria

I have previously received treatment for pancreatic ductal adenocarcinoma.
I have not had major surgery in the past 4 weeks.
I do not have an active infection needing ongoing treatment.
See 25 more

What Are the Treatments Tested in This Trial?

Interventions

  • Avutometinib (VS-6766)
  • Defactinib (VS-6063)

Trial Overview

The study tests two oral drugs, avutometinib and defactinib, taken together along with standard cancer treatment. The goal is to see if this combination is safe and can help shrink or slow the growth of pancreatic tumors.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Neoadjuvant avutometinib + defactinib with standard of care chemotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Verastem, Inc.

Industry Sponsor

Trials
42
Recruited
2,800+

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