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MEK Inhibitor

avutometinib + defactinib for Ovarian Cancer (RAMP 301 Trial)

Phase 3

Recruiting

Led By Rachel Grisham, MD

Research Sponsored by Verastem, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically proven LGSOC (ovarian, fallopian, peritoneal)

Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

RAMP 301 Trial Summary

This trial will test if a drug combo is safer and more effective to treat a specific type of ovarian cancer than existing treatments.

Who is the study for?

This trial is for individuals with recurrent low-grade serous ovarian cancer (LGSOC) who have seen their cancer return or worsen after at least one systemic therapy. Participants must have a certain level of physical fitness (ECOG ≤ 1), measurable disease, and good organ function. They should be recovered from previous treatment side effects and agree to use effective contraception if they can have children.Check my eligibility

What is being tested?

The study tests the combination of two drugs, Avutometinib (VS-6766) and Defactinib (VS-6063), against the Investigator's choice of standard treatments like Topotecan or Paclitaxel in patients with LGSOC. The goal is to see which approach is safer and more effective after prior platinum-based therapy failure.See study design

What are the potential side effects?

Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems, liver or kidney function issues, and possible allergic reactions.

RAMP 301 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with low-grade serous ovarian cancer.

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My low-grade serous ovarian cancer has worsened after treatment.

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I am fully active or can carry out light work.

RAMP 301 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

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

Progression Free Survival (PFS) per blinded independent central review (BICR)

Secondary outcome measures

Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites

Disease Control Rate (DCR)

Duration of Response (DOR)

+7 more

RAMP 301 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: avutometinib + defactinibExperimental Treatment2 Interventions

Avutometinib 3.2 mg, PO, twice weekly (eg, Monday/Thursday, Tuesday/Friday, or Wednesday/Saturday) for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle.

Group II: Investigator Choice of Treatment (ICT)Active Control5 Interventions

Patients will receive one of the following therapies as determined by the Investigator: Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle. Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle. Topotecan: 4 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle. Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle. Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Defactinib

2013

Completed Phase 1

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Verastem, Inc.Lead Sponsor

38 Previous Clinical Trials

2,328 Total Patients Enrolled

4 Trials studying Ovarian Cancer

441 Patients Enrolled for Ovarian Cancer

GOG FoundationNETWORK

42 Previous Clinical Trials

16,471 Total Patients Enrolled

8 Trials studying Ovarian Cancer

3,279 Patients Enrolled for Ovarian Cancer

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER

36 Previous Clinical Trials

16,969 Total Patients Enrolled

11 Trials studying Ovarian Cancer

5,391 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

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

Are there any open spots for participants in this research experiment?

"Affirmative, the data documented on clinicaltrials.gov confirms that this investigation is currently enrolling participants. It was initially published on December 1st 2023 and the most recent update came out of 13th of December 2023. 270 individuals need to be conscripted from a single site."

Answered by AI

What is the cumulative amount of participants registered for this exploration?

"Confirmed, clinicaltrials.gov states that this investigation is recruiting participants as of December 13th 2023. This research endeavour was initially posted on the first day of December in the year 2023 and requires 270 patients from a single medical centre for completion."

Answered by AI

To what extent are the effects of avutometinib + defactinib detrimental to individuals?

"Due to the Phase 3 status of this drug combination, which implies that there is existing data certifying its efficacy and safety, our team at Power rated avutometinib + defactinib as a 3 on a scale from 1-3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

2024. "A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072781.

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