Avutometinib + Defactinib + Chemotherapy for Pancreatic Cancer
(RAMP205 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combining two experimental drugs with two existing treatments for patients with newly diagnosed pancreatic cancer. The goal is to see if this combination can safely and effectively stop cancer growth and kill cancer cells. The study focuses on patients who have not yet received any treatment. One of the existing treatments used in the trial has been important in pancreatic cancer treatment but offers only modest improvements in symptoms and survival.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it excludes those who have had prior treatment for pancreatic cancer or certain other conditions. It's best to discuss your current medications with the trial team.
Is the combination of Avutometinib, Defactinib, and chemotherapy safe for humans?
The combination of nab-paclitaxel and gemcitabine, which are part of the chemotherapy regimen, has been shown to have an acceptable safety profile in patients with advanced pancreatic cancer. However, specific safety data for the combination with Avutometinib and Defactinib is not provided in the available research.12345
What makes the drug combination Avutometinib + Defactinib + Chemotherapy unique for pancreatic cancer?
This drug combination is unique because it includes Avutometinib and Defactinib, which are targeted therapies that may work differently from standard chemotherapy by inhibiting specific pathways in cancer cells, potentially offering a new approach to treating pancreatic cancer compared to traditional treatments like gemcitabine alone.678910
Who Is on the Research Team?
MD Verastem
Principal Investigator
Verastem, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with untreated metastatic pancreatic ductal adenocarcinoma (PDAC), who are in good physical condition (ECOG ≤ 1) and have measurable disease. They must have proper organ and heart function, and agree to use effective contraception. Excluded are those with neuroendocrine tumors, prior PDAC treatments, RAS/MAPK or FAK inhibitor history, other recent malignancies unless cured, major surgery within the last month, severe heart/lung diseases, eye disorders, lung conditions like fibrosis or edema, or a recent SARS-CoV-2 infection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gemcitabine, nab-paclitaxel, avutometinib (VS-6766), and defactinib to determine the recommended phase 2 dose (RP2D) and assess efficacy
Follow-up
Participants are monitored for safety, efficacy, and overall survival after treatment
Long-term follow-up
Participants are monitored for overall survival and disease progression
What Are the Treatments Tested in This Trial?
Interventions
- Avutometinib (VS-6766)
- Defactinib
- Gemcitabine
- Nab-paclitaxel
Avutometinib (VS-6766) is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verastem, Inc.
Lead Sponsor