Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Verastem, Inc.
This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients previously untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
