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Kinase Inhibitor
Avutometinib + Defactinib + Chemotherapy for Pancreatic Cancer (RAMP205 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Verastem, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma
An Eastern Cooperative Group (ECOG) performance status ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
RAMP205 Trial Summary
This trial will test a new combo of drugs to treat people with pancreatic cancer who haven't had treatment before.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of avutometinib (VS-6766) combined with defactinib alongside standard chemotherapy drugs gemcitabine and nab-paclitaxel in patients who haven't been treated before for their pancreatic cancer. The goal is to see if this combination works better than current treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs; typical chemotherapy-related issues like nausea, fatigue; blood cell count changes increasing infection risk; possible cardiac complications due to drug interactions; skin reactions requiring systemic treatment.
RAMP205 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of pancreatic cancer that has spread.
Select...
I am fully active or can carry out light work.
RAMP205 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: To determine RP2D for avutometinib (VS-6766) and defactinib in combination gemcitabine and nab-paclitaxel
To determine the efficacy of the RP2D identified in Part A
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)
+6 moreRAMP205 Trial Design
2Treatment groups
Experimental Treatment
Group I: Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2DExperimental Treatment1 Intervention
To determine the efficacy of the RP2D identified in Part A in untreated metastatic PDAC patients
Group II: Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinibExperimental Treatment1 Intervention
To determine the recommended phase 2 dose (RP2D) for gemcitabine Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib in patients with untreated metastatic PDAC.
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Who is running the clinical trial?
Verastem, Inc.Lead Sponsor
38 Previous Clinical Trials
2,558 Total Patients Enrolled
MD VerastemStudy DirectorVerastem, Inc.
5 Previous Clinical Trials
823 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.I have received treatment for advanced pancreatic cancer.My cancer is a type of pancreatic cancer that has spread.I am fully active or can carry out light work.I have a pancreatic neuroendocrine tumor.I have an eye condition.I have not had major surgery in the last 4 weeks.You have a disease that can be measured using a specific medical guideline called RECIST 1.1.I had cancer before, but it was treated with the intention to cure.My heart is functioning well.I am 18 years old or older.I have had a skin condition that needed treatment through the bloodstream in the last year.You have had a confirmed COVID-19 infection within the past 28 days before starting the study treatment.I have heart disease or severe lung problems.I have not been treated with RAS/MAPK or FAK inhibitors.I have severe lung conditions like interstitial lung disease or pulmonary fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib
- Group 2: Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is enrollment being opened for this research project?
"Indeed, details available on clinicaltrials.gov show that this experiment is actively trying to recruit individuals. It was first posted on the 15th of January in 2023 and most recently updated on the 3rd of January also in 2023, with 40 patients being sought from a single medical centre."
Answered by AI
Is this clinical experiment recruiting participants currently?
"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting patients; it was initially posted on January 15th 2023 and most recently updated on March 1st 2023. 40 participants are needed from a single site for participation in the study."
Answered by AI
What are the primary aims of this research endeavor?
"The study sponsor, Verastem Inc., has declared that the primary outcome to be measured over a period of 28 days is determining efficacy at the RP2D identified in Part A. Secondary outcomes include Duration of Response (TFO), Overall Survival (OS) and Plasma Pharmacokinetics (PK). Additionally, they will measure Tmax or Time to Maximum concentration."
Answered by AI
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