Share
Save
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
Study details:
This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior platinum-based therapy. Avutometinib and defactinib are both types of drugs called kinase inhibitors. Kinase inhibitors block cancer cell growth.
The study will compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health-related quality of life and disease related symptoms. The study is being conducted by gynecological cancer specialists.
Patients who are eligible and agree to participate in this study will be treated with either a combination of avutometinib with defactinib, or with one of four standard of care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with subsequent follow up appointments. Patients who originally received one of the standards of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination avutometinib plus defactinib. Avutometinib and defactinib are investigational drugs that have not been approved by the U.
S. Food and Drug Administration (FDA).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Female
Things to know
Study dates
Study start: 2024-03-18
Primary completion: 2028-10-15
Study completion finish: 2031-02-09
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06072781
Intervention or treatment
DRUG: avutometinib
DRUG: Defactinib
DRUG: Pegylated liposomal doxorubicin
DRUG: Paclitaxel
DRUG: Letrozole
DRUG: Anastrozole
Conditions
- • Low Grade Serous Ovarian Cancer
Find a site
Closest Location:
Prince of Wales Hospital
Research sites nearby
Select from list below to view details:
Prince of Wales Hospital
Randwick, New South Wales, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: avutometinib + defactinib
| DRUG: avutometinib
|
ACTIVE_COMPARATOR: Investigator Choice of Treatment (ICT)
| DRUG: Pegylated liposomal doxorubicin
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Progression Free Survival (PFS) per blinded independent central review (BICR) | Confirmed overall response rate per RECIST 1.1 per blinded independent central review (BICR) | Up to 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall Survival (OS) | From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause | Up to 5 years |
Progression Free Survival (PFS) per investigator assessment | From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause | 24 months |
Objective response rate (ORR) | From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause | 12 months |
Duration of Response (DOR) | From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause | 12 months |
Disease Control Rate (DCR) | CR+PR+Stable disease | 6 months |
Frequency and severity 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 | 25 months |
Area under the plasma concentration-time curve (AUC) of avutometinib, defactinib and relative metabolites | Area under plasma Concentration (AUC) 0 to t | 5 months |
Maximum plasma concentration (Cmax) of avutometinib, defactinib and relative metabolites | maximum plasma concentration | 5 months |
To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30). | The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of ovarian cancer patients. | 24 months |
To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Ovarian Cancer module OV28 (QLQ-OV28). | The EORTC QLQ-OV28 is a validated questionnaire to assess the quality of life of ovarian cancer patients. | 24 months |
To assess the health-related quality of life and disease based on EuroQol-5 Dimension 5-level (EQ-5D-5L) | The EuroQol-5 Dimension 5-level (EQ-5D-5L) is a validated questionnaire used to measure a patient's overall health. | 24 months |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!