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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

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Disease Control Rate (DCR)

Duration of Response (DOR)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: avutometinib + defactinibExperimental Treatment2 Interventions

Avutometinib 3.2 mg, PO, twice weekly 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 Control4 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. * 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