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New drug cocktail targets tough ovarian cancer in japanese women

NCT ID NCT06682572

Disease control Sponsor: Verastem, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests a combination of two drugs, avutometinib and defactinib, in 16 Japanese patients whose low-grade serous ovarian cancer has returned after platinum-based chemotherapy. The goal is to see if the combo can shrink tumors and how safe it is. The trial is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
avutometinib and defactinib (combination pill)
What this could lead to
If successful, this could provide a new treatment option for Japanese patients with recurrent low-grade serous ovarian cancer, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is a small, early-phase trial with only 16 participants, so results may not apply to all patients. The combination may cause side effects and may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

16 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically proven LGSOC (ovarian, peritoneal) * Documented mutational status of KRAS by validated diagnostic test of tumor tissue * Documented disease progression (radiographic or clinical) or recurrence of LGSOC and have received at least one platinum-based chemotherapy agent * Measurable disease according to RECIST 1.1 * An Eastern Cooperative Group (ECOG) performance status ≤ 1. * Adequate organ function * Adequate recovery from toxicities related to prior treatments * Agreement to use highly effective method of contraceptive, if necessary Exclusion Criteria: * Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy * Co-existing high-grade ovarian cancer or another histology * History of prior malignancy, excluding ovarian cancer, with recurrence \<3 years from the time of enrollment * Major surgery within 4 weeks * Symptomatic brain metastases requiring steroids or other interventions * Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy * For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor * Active skin disorder that has required systemic therapy within the past year * History of rhabdomyolysis * Concurrent ocular disorders * Concurrent heart disease or severe obstructive pulmonary disease * Patients with the inability to swallow oral medications

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Conditions

The condition(s) this trial relates to.

borderline ovarian serous tumor ovarian cancer ovarian serous adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low-grade serous ovarian cancer Ovarian cancer

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Jikei University Hospital

    Minato, Tokyo, 105-0003, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

More trials for these conditions

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