Study on Avutometinib (VS-6766) and Defactinib with Gemcitabine and Nab-paclitaxel for Pancreatic Cancer

Sponsor: Verastem, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05669482

Provider View

This clinical trial is testing a new combination of drugs, including Avutometinib (VS-6766) and Defactinib, with Gemcitabine and Nab-paclitaxel, to see if they are safe and effective for patients with pancreatic cancer who have not received any previous treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment combination for patients with pancreatic ductal adenocarcinoma (PDAC) that has spread and has not been treated before. The treatment includes Avutometinib (VS-6766), Defactinib, Gemcitabine, and Nab-paclitaxel. Researchers aim to find out if this combination can help manage the cancer and how well patients tolerate it.

Description

This study is being conducted at multiple centers and is open to patients who have not received any prior treatment for their metastatic pancreatic ductal adenocarcinoma (PDAC). The study is in Phase 1/2, which means it is focused on assessing the safety, tolerability, and effectiveness of the drug combination. Participants will receive Avutometinib (VS-6766) and Defactinib along with Gemcitabine and Nab-paclitaxel, and researchers will monitor their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have measurable cancer according to standard criteria.
  • Have adequate organ and heart function as determined by specific medical tests.
  • Agree to use a highly effective method of contraception during the study.

Exclusion Criteria

  • Have pancreatic neuroendocrine tumors.
  • Have received any prior treatment for metastatic pancreatic ductal adenocarcinoma.
  • Have previously been treated with drugs targeting the RAS/MAPK pathway or FAK inhibitors.
  • Have a history of other cancers, unless they have been treated and cured.
  • Have had major surgery within the past four weeks, except for procedures to place vascular access.
  • Have ongoing heart disease or severe lung disease.
  • Have eye disorders that are currently affecting vision.
  • Have active skin conditions that required treatment in the past year.
  • Have lung diseases like interstitial lung disease, pulmonary fibrosis, or severe respiratory conditions.
  • Have had a known COVID-19 infection within 28 days before starting the study treatment.

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