Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Conditions
Brief summary
Part A: Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) as assessed by the blinded independent radiology review committee (BIRC) Part B: Confirmed ORR defined according to RECIST 1.1 as assessed by the BIRC Part C: Confirmed ORR defined according to RECIST 1.1 as assessed by the BIRC Part D: Confirmed ORR defined according to RECIST 1.1 as assessed by the BIRC
Detailed description
Part A, B, C and D: 1) Adverse events (AEs), serious AEs (SAEs), physical examinations, clinical laboratory values and tolerability (dose interruptions/reductions), 2) - Duration of response (DOR) - ORR as assessed by the Investigator - Progression free survival (PFS), defined as the time from first dose of study intervention to the first documentation of progressive disease (PD), or death from any cause - Disease control rate (DCR), defined as CR+PR+ stable disease (SD) - Overall survival (OS), 3) PK parameters derived from plasma concentrations of avutometinib, defactinib, and relevant metabolites
Sponsors
Verastem Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) as assessed by the blinded independent radiology review committee (BIRC) Part B: Confirmed ORR defined according to RECIST 1.1 as assessed by the BIRC Part C: Confirmed ORR defined according to RECIST 1.1 as assessed by the BIRC Part D: Confirmed ORR defined according to RECIST 1.1 as assessed by the BIRC | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A, B, C and D: 1) Adverse events (AEs), serious AEs (SAEs), physical examinations, clinical laboratory values and tolerability (dose interruptions/reductions), 2) - Duration of response (DOR) - ORR as assessed by the Investigator - Progression free survival (PFS), defined as the time from first dose of study intervention to the first documentation of progressive disease (PD), or death from any cause - Disease control rate (DCR), defined as CR+PR+ stable disease (SD) - Overall survival (OS), 3) PK parameters derived from plasma concentrations of avutometinib, defactinib, and relevant metabolites | — |
Countries
Belgium, France, Italy, Spain
Outcome results
None listed