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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
Must not have
Treatment with warfarin
Exposure to P-glycoprotein (P-gp) inhibitors or inducers within 14 days prior to the first dose and during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My gynecological cancer has worsened or returned after treatment.
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My gynecological cancer has specific genetic changes.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking warfarin.
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I haven't taken any P-gp affecting drugs in the last 14 days.
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I have low grade serous ovarian cancer.
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I have an eye condition.
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I do not have severe heart or lung conditions.
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I haven't taken strong CYP2C9 or CYP3A4 inhibitors or inducers in the last 14 days.
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I have had rhabdomyolysis before.
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I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.
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I am not pregnant or breastfeeding.
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I have an active hepatitis B, C, or HIV infection needing treatment.
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I need medication or treatment for brain cancer symptoms.
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I have had COVID-19 symptoms within the last 28 days.
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I have been treated with MEKi or RAFi drugs before.
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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.
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I have had cancer before, but it did not come back within 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Patients with objective response rate
Secondary study objectives
Disease Control Rate
Duration of Response
Incidence of Adverse Events
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
41 Previous Clinical Trials
2,780 Total Patients Enrolled
University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,636 Total Patients Enrolled
Christina Washington, MDPrincipal InvestigatorOU Health, Stephenson Cancer Center
2 Previous Clinical Trials
77 Total Patients Enrolled

Media Library

Avutometinib (VS-6766) (MAPK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05512208 — Phase 2
Cervical Cancer Research Study Groups: Avutometinib (VS-6766) + Defactinib
Cervical Cancer Clinical Trial 2023: Avutometinib (VS-6766) Highlights & Side Effects. Trial Name: NCT05512208 — Phase 2
Avutometinib (VS-6766) (MAPK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05512208 — Phase 2
~34 spots leftby Dec 2027
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