← Back to Search

Kinase Inhibitor

Avutometinib vs. Avutometinib + Defactinib for Ovarian Cancer (RAMP 201 Trial)

Phase 2
Waitlist Available
Led By Susana Banerjee, MBBS,MA,PhD
Research Sponsored by Verastem, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease
Histologically proven LGSOC (ovarian, peritoneal)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

RAMP 201 Trial Summary

This trial will look at the safety and effectiveness of VS-6766 by itself and with Defactinib in women with LGSOC that has come back.

Who is the study for?
This trial is for individuals with recurrent Low-Grade Serous Ovarian Cancer who've had at least one prior treatment. Participants must have good organ function, manageable side effects from previous treatments, measurable disease, and an ECOG performance status ≤ 1. They should not have severe concurrent diseases or a recent history of certain conditions like SARS-CoV-2 infection.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of avutometinib alone versus in combination with defactinib for those with LGSOC. It aims to see which treatment works better for patients who have seen their cancer return after other therapies.See study design
What are the potential side effects?
Potential side effects may include skin reactions, eye disorders if pre-existing, muscle breakdown (rhabdomyolysis), heart issues or severe lung problems if already present. Side effects specific to the drugs will be monitored throughout the trial.

RAMP 201 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My low-grade serous ovarian cancer has worsened after treatment.
Select...
My cancer is low-grade serous ovarian or peritoneal.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.

RAMP 201 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib
Part B: To determine the efficacy of the optimal regimen identified from Part A
Part C: To evaluate additional efficacy parameters for the optimal regimen identified in Part A
+1 more
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Response Rate as assessed by Investigator
+2 more

RAMP 201 Trial Design

4Treatment groups
Experimental Treatment
Group I: Part DExperimental Treatment1 Intervention
To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Group II: Part C:Experimental Treatment1 Intervention
To evaluate additional efficacy parameters for the optimal regimen identified in Part A.
Group III: Part BExperimental Treatment2 Interventions
To determine the efficacy of the optimal regimen identified from Part A
Group IV: Part AExperimental Treatment2 Interventions
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
avutometinib (VS-6766)
2020
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,414 Total Patients Enrolled
9 Trials studying Ovarian Cancer
4,566 Patients Enrolled for Ovarian Cancer
GOG FoundationNETWORK
41 Previous Clinical Trials
15,916 Total Patients Enrolled
6 Trials studying Ovarian Cancer
2,454 Patients Enrolled for Ovarian Cancer
Verastem, Inc.Lead Sponsor
38 Previous Clinical Trials
2,373 Total Patients Enrolled
3 Trials studying Ovarian Cancer
216 Patients Enrolled for Ovarian Cancer

Media Library

Avutometinib (VS-6766) (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04625270 — Phase 2
Ovarian Cancer Research Study Groups: Part D, Part C:, Part A, Part B
Ovarian Cancer Clinical Trial 2023: Avutometinib (VS-6766) Highlights & Side Effects. Trial Name: NCT04625270 — Phase 2
Avutometinib (VS-6766) (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04625270 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being recruited to partake in this clinical trial?

"To successfully execute this trial, one hundred participants must be identified who meet the necessary inclusion criteria. Potential study members can attend sites such as Cleveland Clinic Women's Health Institute in Ohio and The Ohio State University Wexner Medical Center in Columbus, New mexico."

Answered by AI

What potential risks have been associated with the intake of VS-6766 and Defactinib?

"Our hazard assessment of VS-6766 and Defactinib was a 2 as there is limited evidence confirming their safety, but no clinical data yet to confirm efficacy."

Answered by AI

To what extent has research been conducted on the efficacy of VS-6766 and Defactinib?

"At the moment, there are 9 active clinical trials testing VS-6766 and Defactinib with no Phase 3 studies. While many of these experiments have their roots in San Diego, California, a total of 1557 medical facilities around the world are conducting research on both medications."

Answered by AI

What results are expected from this medical experiment?

"Verastem, Inc., the sponsor of this clinical trial, has identified a 24-week period in which to measure their primary outcome: determining the optimal dosage for VS-6766 either alone or combined with defactinib. Additionally, secondary outcomes including overall response rate (proportioned subjects achieving CR/PR), duration of response from time of first response to PD as assessed by BIRC, and disease control rate (CR+PR+stable disease) will be evaluated."

Answered by AI

Has recruitment for this research endeavor commenced?

"Per the records on clinicaltrials.gov, this investigation is currently still looking for volunteers. It was initially posted on December 21st 2020 and its most recent update occurred on September 14th 2022."

Answered by AI

Are there multiple healthcare facilities conducting this investigation in Canada?

"Patients are being recruited for this trial at a variety of locations, including Cleveland Clinic Women's Health Institute in Cleveland, Ohio; The Ohio State University Wexner Medical Center in Columbus, New mexico; and the University of New Mexico Comprehensive Cancer Center in Albuquerque, Texas. Additionally there are another 30 sites involved."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
2020. "A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04625270.
~34 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top