To confirm the efficacy of Avutometinib in combination with Defactinib in Japanese patients with LGSOC.

JRCT ID: jRCT2021240021

Registered date:23/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
• Date of first enrollment: 01/11/2024
• Target sample size: 15
• Study type: Interventional

Intervention(s)

Patients will receive avutometinib 3.2 mg PO twice weekly (BIW) for 21 days in each 28-day cycle and defactinib 200 mg PO twice daily (BID) for 21 days in each 28-day cycle.
Study treatment should continue until one of the following criteria occurs:
- Patient withdrawal of consent
- Disease progression per RECIST v1.1 confirmed by BICR
- Clinical progression/deterioration (at the discretion of the Investigator)
- Study intervention interruption for > 28 days due to treatment-related toxicity, unless approved by study Medical Monitor
- Unacceptable toxicity (as defined by the Investigator)
- Pregnancy
- Lost to follow-up
- Death
- Termination of the study by the Sponsor
- Other reasons, including major protocol violation or noncompliance

Outcome(s)

• Primary Outcome: Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) as assessed by the blinded independent central radiology review committee (BICR)

Secondary Outcome

The main secondary endpoints are as follows
Adverse events (AEs), serious AEs (SAEs), physical examinations, clinical laboratory values and tolerability (dose interruptions/reductions)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

The main Inclusion Criteria are as follows. Please contact us for more details.

1.Histologically proven LGSOC (ovarian, fallopian, peritoneal)
(LGSOC in conjunction with serous borderline tumor is permitted)
(Adequate tumor tissue must be available for central confirmation of LGSOC. )
2. Documented mutational status of KRAS by a validated diagnostic test from tumor tissue.
Adequate tumor tissue (preferably less than 5 years as defined in the laboratory manual) must be available for submission.
3. Documented disease progression (radiographic or clinical) or recurrence of LGSOC and have received at least one platinum-based chemotherapy regimen.
4. At least one measurable lesion according to RECIST v1.1.
5. Adequate organ function.

Exclude criteria

The main Exclusion Criteria are as follows. Please contact us for more details.

1. Systemic anti-cancer therapy within 4 weeks of the first dose of study intervention or clinical trial.
2. High-grade ovarian cancer or mixed histology.
3. History of prior malignancy with recurrence within the last 3 years.
4. Specific concurrent ocular disorders: (exanple) History of glaucoma, History of retinal pathology, Corneal disorders etc.
5. Uncontrolled (persistent) hypertension: systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.

Related Information

• Primary Sponsor: Kitano Tina