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FAK Inhibitor

Defactinib for Cancer with NF2 Mutations

Phase 2

Waitlist Available

Led By David M Jackman

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a tumor that harbors an inactivating mutation in NF2

Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Awards & highlights

Study Summary

This trial is testing defactinib to see if it can shrink or stop the growth of cancer in patients with NF2 mutations.

Who is the study for?

This trial is for cancer patients with a specific genetic change called NF2 mutation. They must have passed previous MATCH Protocol criteria, have no serious heart issues or uncontrolled high blood pressure, and not be allergic to defactinib. People with recent GI bleeding, Gilbert's syndrome, stroke history within 6 months, prior FAK inhibitor treatment like defactinib or certain drug/food interactions are excluded.Check my eligibility

What is being tested?

The trial tests VS-6063 (defactinib hydrochloride), which may block the FAK protein that supports cancer cell growth in patients with NF2 mutations. The goal is to see if it can shrink these cancers or halt their progression.See study design

What are the potential side effects?

Potential side effects of defactinib include but are not limited to: risks associated with heart rhythm changes due to its interaction with cardiac function and possible gastrointestinal complications such as bleeding or ulceration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor has an NF2 mutation.

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My recent ECG showed no significant heart issues.

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My heart's pumping ability is normal according to recent tests.

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My high blood pressure is under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR)

Secondary outcome measures

Overall survival (OS)

Progression free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (defactinib)Experimental Treatment1 Intervention

Patients receive defactinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,632 Total Patients Enrolled

David M JackmanPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Defactinib Hydrochloride (FAK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439331 — Phase 2

Cancer Research Study Groups: Treatment (defactinib)

Cancer Clinical Trial 2023: Defactinib Hydrochloride Highlights & Side Effects. Trial Name: NCT04439331 — Phase 2

Defactinib Hydrochloride (FAK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439331 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently seeking participants?

"Data on clinicaltrials.gov indicates that this research project is no longer recruiting candidates, having initially been posted in August 2015 and last updated September 2022. Nonetheless, there are still 4678 other trials actively looking for volunteers at present."

Answered by AI

Could you expound upon any prior research pertaining to Defactinib Hydrochloride?

"At the moment, Defactinib Hydrochloride is currently being studied in 9 live trials with 0 of them at Phase 3. San Diego, California is home to many of these clinical studies; nevertheless, there are 1557 facilities around the world running research on this compound."

Answered by AI

How hazardous is Defactinib Hydrochloride for patients?

"Although yet to be proven effective, defactinib hydrochloride has generated sufficient safety data during its Phase 2 trial and is assigned a score of 2."

Answered by AI

What is the cap on participation for this medical research?

"This experiment is no longer accepting applicants. It was made available on August 12th of 2015, and the latest update was recorded a few days ago on September 13th 2022. As an alternative to this trial, there are presently 4669 clinical trials actively seeking patients with lymphoma and 9 additional studies searching for participants interested in Defactinib Hydrochloride treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing VS-6063 (Defactinib) as a Potential Targeted Treatment in Cancers With NF2 Genetic Changes (MATCH-Subprotocol U)

2015. "Testing VS-6063 (Defactinib) as a Potential Targeted Treatment in Cancers With NF2 Genetic Changes (MATCH-Subprotocol U)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439331.