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MAPK Inhibitor
Avutometinib + Defactinib for Ovarian and Cervical Cancer (DURAFAK Trial)
Phase 2
Recruiting
Led By Christina Washington, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Progression (radiographic or clinical) or recurrence of gynecological cancer after at least one prior systemic therapy for metastatic disease
Histologically proven gynecological cancers with mutated RAS, BRAF (type I, II, and/or III), NF-1 loss of function, and/or RAS activation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
DURAFAK Trial Summary
This trial is testing two drugs to treat endometrioid, mucinous ovarian, high-grade serous ovarian, or cervical cancer.
Who is the study for?
This trial is for women over 18 with certain types of gynecological cancers that have mutated genes and have worsened after at least one treatment. They must be relatively healthy, not pregnant or breastfeeding, able to use birth control, and not have had recent surgeries or certain other treatments.Check my eligibility
What is being tested?
The study tests the combination of two drugs, Avutometinib (VS-6766) and defactinib, on patients with specific ovarian or cervical cancers. It aims to evaluate their effectiveness in controlling cancer growth and assess the safety profile of this drug regimen.See study design
What are the potential side effects?
Possible side effects include typical reactions from cancer medications such as fatigue, digestive issues, skin problems, blood disorders. There may also be risks related to liver function changes due to the medication's interaction with other substances.
DURAFAK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My gynecological cancer has worsened or returned after treatment.
Select...
My gynecological cancer has specific genetic changes.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
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My organ functions are within normal ranges according to recent tests.
DURAFAK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Patients with objective response rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Incidence of Adverse Events
+2 moreDURAFAK Trial Design
1Treatment groups
Experimental Treatment
Group I: Avutometinib (VS-6766) + DefactinibExperimental Treatment1 Intervention
Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week
Defactinib: will be administered at 200 mg orally twice a day (BID).
Find a Location
Who is running the clinical trial?
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,543 Total Patients Enrolled
4 Trials studying Ovarian Cancer
441 Patients Enrolled for Ovarian Cancer
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,555 Total Patients Enrolled
3 Trials studying Ovarian Cancer
129 Patients Enrolled for Ovarian Cancer
Christina Washington, MDPrincipal InvestigatorOU Health, Stephenson Cancer Center
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking warfarin.I haven't taken any P-gp affecting drugs in the last 14 days.I have low grade serous ovarian cancer.I have an eye condition.I do not have severe heart or lung conditions.You have a disease that can be accurately measured using specific medical guidelines.My gynecological cancer has specific genetic changes.There must be enough tissue samples for confirmation before starting treatment.I haven't taken strong CYP2C9 or CYP3A4 inhibitors or inducers in the last 14 days.I have had rhabdomyolysis before.I am not pregnant or breastfeeding.My cancer's genetic changes have been tested.I have a skin condition that needed treatment through pills or injections in the last year.I agree to use effective birth control during and for 3 months after the trial.My gynecological cancer has worsened or returned after treatment.I am a woman aged 18 or older.I have recovered from previous cancer treatment side effects.I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.I am fully active and can carry on all my pre-disease activities without restriction.I have an active hepatitis B, C, or HIV infection needing treatment.I need medication or treatment for brain cancer symptoms.I have had COVID-19 symptoms within the last 28 days.I haven't had any cancer treatments in the last 4 weeks.I have been treated with MEKi or RAFi drugs before.I haven't had major surgery in the last 4 weeks, minor surgery in the last 2 weeks, or palliative radiotherapy in the last week.I have had cancer before, but it did not come back within 3 years.My doctor thinks surgery to remove as much of the tumor as possible is a good option for me.My organ functions are within normal ranges according to recent tests.
Research Study Groups:
This trial has the following groups:- Group 1: Avutometinib (VS-6766) + Defactinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards might arise from the simultaneous administration of VS-6766 and defactinib?
"Our team at Power recognised the safety of VS-6766 + defactinib by giving it a score of two. This is based on this being a Phase 2 trial, which implies that there are some clinical data points supporting its safety but non in favour of efficacy."
Answered by AI
Does this clinical trial have an age restriction, and if so, is it over or under sixty?
"The study is open to any potential participant from the age of 18 and up, with no upper limit on age."
Answered by AI
Are there any criteria for joining this experiment?
"The prerequisites for enrolment into this trial are that patients have mucinous ovarian cancer and be between the ages of 18-99. The maximum number of participants is 55 people."
Answered by AI
Is this test enrolling participants currently?
"The clinical trial log hosted by clinicaltrials.gov indicates that, despite having been posted on December 1st 2022 and updated last August 19th 2022, this study is currently not recruiting patients. Nevertheless, there are still 780 medical trials actively seeking participants at the moment."
Answered by AI
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