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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
combination therapy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Confirmed overall response rate (ORR; partial response [PR] + complete response [CR]
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)
Time frame: From start of treatment to confirmation of response; 24 weeks
Duration of Response
From the time of first dose of study intervention to PD as assessed by RECIST 1.1 or death from any cause
Time frame: 12 months
Objective response rate (ORR)
From the time of first dose of study intervention to PD as assessed by RECIST 1.1 by Investigator or death from any cause.
Time frame: 12 months
Progression free survival (PFS)
From the time of first dose of study intervention to first documentation of progressive disease (PD) or death by any cause
Time frame: 24 months
Disease control rate (DCR)
CR + PR + SD
Time frame: 6 months
Clinical benefit rate
CR + PR + (SD \>6 months)
Time frame: 6 months
Overall Survival (OS)
From the time of first dose of study intervention to PD as assessed by RECIST 1.1 or death from any cause
Time frame: up to 2 years
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Jikei University Hospital
Minato, Tokyo, Japan
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale
Time frame: 18 months
Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites
Area under Plasma Concentration (AUC) 0 to t
Time frame: 9 months
Maximum plasma concentration (Cmax) of avutometinib, defactinib and relative metabolites
Maximum Plasma Concentration
Time frame: 9 months