Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer

Description

This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.

Conditions

KRAS Activating Mutation, Metastatic Cancer, Pancreas Cancer, Neoplasms Pancreatic, Malignant Neoplasm of Pancreas

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Study Overview

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Study Details

Study overview

This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.

A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination With Avutometinib (VS-6766) and Defactinib in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas

Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer

Condition
KRAS Activating Mutation
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94158

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Ann Arbor

University of Michigan Cancer Center, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States, 10016

New York

New York Presbyterian/Weill-Cornell Medical Center, New York, New York, United States, 10021

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Salt Lake City

University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female subjects ≥ 18 years of age
  • * Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma.
  • * An Eastern Cooperative Group (ECOG) performance status ≤ 1
  • * Measurable disease according to RECIST 1.1
  • * Adequate organ function
  • * Adequate cardiac function
  • * Agreement to use highly effective method of contraceptive
  • * Patients with pancreatic neuroendocrine tumors
  • * Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma
  • * Prior treatment with inhibitors of the RAS /MAPK pathway \[e.g. MEK inhibitors\] or inhibitors of FAK
  • * History of prior malignancy, with the exception of curatively treated malignancies
  • * Major surgery within 4 weeks (excluding placement of vascular access)
  • * Concurrent heart disease or severe obstructive pulmonary disease
  • * Concurrent ocular disorders
  • * Active skin disorder that has required systemic therapy within the past 1 year
  • * Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome
  • * Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Verastem, Inc.,

MD Verastem, STUDY_DIRECTOR, Verastem, Inc.

Study Record Dates

2025-12-31