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A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients

NCT ID: NCT06682572

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2027-10-31

Brief Summary

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This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Detailed Description

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This is a multi-center, open label Phase 2 study designed to evaluate safety and tolerability and confirm efficacy by BICR of avutometinib in combination with defactinib in Japanese patients with molecularly profiled recurrent LGSOC.

Conditions

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Low Grade Serous Ovarian Cancer Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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avutometinib + defactinib

Avutometinib 3.2mg, 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 Type EXPERIMENTAL

Avutometinib (VS-6766) + Defactinib (VS-6063)

Intervention Type DRUG

combination therapy

Interventions

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Avutometinib (VS-6766) + Defactinib (VS-6063)

combination therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Japanese Gynecologic Oncology Group

OTHER

Sponsor Role collaborator

Verastem, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Site Status

Kurume University Hospital

Kurume, Fukuoka, Japan

Site Status

Mie University Hospital

Tsu, Mie-ken, Japan

Site Status

Tohoku University Hospital

Sendai, Miyagi, Japan

Site Status

Jikei University Hospital

Minato, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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jRCT2021240021

Identifier Type: OTHER

Identifier Source: secondary_id

VS-6766-201J

Identifier Type: -

Identifier Source: org_study_id