Combination treatment for metastatic pancreatic cancer using new drugs and chemotherapy
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
This study is testing a new combination of drugs with chemotherapy to see if it can help people with advanced pancreatic cancer feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Verastem, Inc. Industry-sponsored |
| Drugs / interventions | avutometinib, defactinib |
| Locations | 12 sites (San Francisco, California and 11 other locations) |
| Trial ID | NCT05669482 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a combination of avutometinib (VS-6766) and defactinib with gemcitabine and nab-paclitaxel in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). It is a multicenter, non-randomized, open-label Phase 1/2 study that aims to determine how well these treatments work together. The study will assess various outcomes including safety, tolerability, and effectiveness in managing the disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic pancreatic ductal adenocarcinoma and an ECOG performance status of 1 or lower.
Not a fit: Patients with pancreatic neuroendocrine tumors or those who have received prior treatment for metastatic pancreatic ductal adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic pancreatic cancer.
How similar studies have performed: Other studies have shown promise with similar combinations of targeted therapies and chemotherapy in treating pancreatic cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
San Francisco, California and 11 other locations
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Michigan Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (Recruiting)
- New York Presbyterian/Weill-Cornell Medical Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- Virginia Mason Medical Center — Seattle, Washington, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Verastem Call Center
- Email: clinicaltrials@verastem.com
- Phone: 1 781 292 4204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.