ACTIVE_NOT_RECRUITING

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

Conditions

KRAS Activating Mutation Metastatic Cancer Pancreas Cancer Neoplasms Pancreatic Malignant Neoplasm of Pancreas avutometinib (VS-6766)KRAS Mutation Pancreatic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-03-22

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05669482

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

MD Verastem

STUDY_DIRECTOR

Verastem, Inc.

Study Locations (Sites)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158

United States

University of Chicago

Chicago, Illinois, 60637

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109

United States

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016

United States

New York Presbyterian/Weill-Cornell Medical Center

New York, New York, 10021

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Virginia Mason Medical Center

Seattle, Washington, 98101

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Verastem, Inc.

MD Verastem, STUDY_DIRECTOR, Verastem, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-22

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-03-22

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

avutometinib (VS-6766)
Metastatic Cancer
KRAS Mutation
Pancreatic Cancer

Additional Relevant MeSH Terms

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