Comparing avutometinib with Pegylated liposomal doxorubicin for low grade serous ovarian cancer
Official title: A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)
Interventions
avutometinib
Avutometinib: administered orally
Defactinib
Defactinib: administered orally
Pegylated liposomal doxorubicin
administered intravenously
Paclitaxel
administered intravenously
Letrozole
administered orally
Anastrozole
administered orally
Canadian Sites (4)
British of Columbia
Vancouver, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for29 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients may be eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → in the study if they meet the following criteria:
- +Histologically proven LGSOC (ovarian, fallopian, peritoneal)
- +Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
- +Suitable for treatment with at least one of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
- +Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
- +Measurable disease according to RECIST v1.1.
- +An Eastern Cooperative Group (ECOG) performance status ≤ 1.
- +Adequate organ function.
- +Adequate recovery from toxicities related to prior treatments.
- +Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- +For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
Exclusion
- −History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
- −Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
- −Patients will be excluded from the study if they meet any of the following criteria:
- −Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
- −Co-existing high-grade serous ovarian cancer or mixed histology.
- −Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
- −History of prior malignancy with recurrence \<3 years from the time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- −An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
- −History of medically significant rhabdomyolysis.
- −For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
- −Symptomatic bowel obstruction within 3 months of the first dose of study intervention
- −Concurrent ocular disorders.
- −Concurrent heart disease or severe obstructive pulmonary disease.
- −Subjects with the inability to swallow oral medications.
- −Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.
- −Pregnant or breastfeeding.
- −Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
- −Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, and 2 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 270 people.
The study is currently expected to finish around February 2031.
The main measurement is taken over: Up to 24 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression Free Survival (PFS) per blinded independent central review (BICR) — measured over Up to 24 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06072781 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About avutometinibDrug
Avutometinib: administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DefactinibDrug
Defactinib: administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Pegylated liposomal doxorubicinDrug
administered intravenously
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PaclitaxelDrug
administered intravenously
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LetrozoleDrug
administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AnastrozoleDrug
administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 24 months.
The study as a whole is currently expected to finish around 2031-02-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 270 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: Vancouver, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Buffalo, New York, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (4)
Karmanos Cancer Center
Detroit, Michigan, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.