Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Andrew Ko, MD
Headshot of Andrew Ko
Andrew Ko

Description

Summary

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

Details

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).

Keywords

KRAS Activating Mutation, Metastatic Cancer, Pancreas Cancer, Neoplasms Pancreatic, Malignant Neoplasm of Pancreas, avutometinib (VS-6766), KRAS Mutation, Pancreatic Cancer, Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms, Paclitaxel, Gemcitabine, avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel, Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib, Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • Virginia Mason Medical Center accepting new patients
    Seattle Washington 98101 United States

Lead Scientist at UCSF

  • Andrew Ko, MD
    Professor, Medicine, School of Medicine. Authored (or co-authored) 135 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Verastem, Inc.
ID
NCT05669482
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated