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Protein Kinase Inhibitor
Defactinib + VS-6766 for Uveal Melanoma
Phase 2
Waitlist Available
Led By Takami Sato
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Written (signed and dated) informed consent and be capable of cooperating with treatment and follow-up
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 28 days after the last dose of treatment
Awards & highlights
Study Summary
This trial is studying the effect of combining two drugs to treat patients with uveal melanoma that has spread. The drugs may block cell signaling pathways that are important for the growth of the cancer, and may result in shrinkage or stabilization of the cancer and prolonged time to disease progression and survival.
Who is the study for?
Adults with metastatic uveal melanoma, good heart function, and no severe systemic diseases. They must not be pregnant or breastfeeding and agree to use effective contraception. Participants need stable vital signs and blood counts within specific ranges, can't have had recent major surgery or certain treatments, and must not have active infections like hepatitis or HIV.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Defactinib Hydrochloride and Raf/MEK Inhibitor VS-6766 on patients with metastatic uveal melanoma. It aims to see if blocking cell signaling pathways slows down cancer growth or shrinks tumors.See study design
What are the potential side effects?
Potential side effects may include issues affecting the heart, liver, digestive system due to drug interactions; vision problems in the unaffected eye; increased risk of infection; allergic reactions to inactive ingredients in the medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have signed and understand the consent form and can follow the treatment plan.
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I am fully active or can carry out light work.
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I agree to use effective birth control during and for 3 months after the trial.
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My heart pumps well, confirmed by a heart scan.
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My healthy eye does not have retinopathy or retinal vein occlusion.
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My cancer, originating in the eye, has spread to other parts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days after the last dose of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after the last dose of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response
Disease control rate
Secondary outcome measures
Incidence of adverse events
Overall Survival (OS)
Progression-free Survival (PFS)
Other outcome measures
Changes in apoptosis induction (caspase activation)
Changes in cell proliferation (Ki67)
Changes in signaling to the ERK, YAP, FAK, and PI3K TOR pathways
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (defactinib, VS-6766)Experimental Treatment3 Interventions
Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,701 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,585 Total Patients Enrolled
Takami SatoPrincipal InvestigatorThomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My white blood cell count is high enough for the trial.I have signed and understand the consent form and can follow the treatment plan.I am fully active or can carry out light work.I cannot take pills by mouth or have issues absorbing them due to stomach surgery or active bowel inflammation.Your creatine phosphokinase level should be within a certain range when tested before starting the trial.I have recovered from previous treatment side effects, except for hair loss or mild nerve damage.I agree to use effective birth control during and for 3 months after the trial.Your heart's electrical activity, measured by an ECG, should be within a certain range.I haven't had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.I have had issues like a hole in my stomach or intestines or severe gut infections.Your blood clotting test (INR) should be within a certain range, either without medication or at the right level with medication, when tested in the two weeks before starting the trial.I do not have severe heart or lung conditions.I haven't taken corticosteroids as cancer treatment in the last 14 days.Your bilirubin level in your blood is not more than 1.5 times the upper limit of normal.My kidney function, measured by creatinine clearance, is adequate.My blood clotting time is within the normal range without blood thinners, or controlled with them.My heart pumps well, confirmed by a heart scan.I have a serious health condition not related to cancer, like an uncontrolled infection.I have pancreatitis.I don't have severe side effects from past treatments, except for possible hair loss or mild issues.I haven't had cancer treatments like chemotherapy in the last 4-6 weeks.I don't have active brain metastases needing steroids for symptoms.I am a male willing to use contraception during and 6 months after the trial.My healthy eye does not have retinopathy or retinal vein occlusion.You are allergic to certain ingredients in the study drug.My cancer can be measured on scans taken within the last 28 days.I haven't taken strong CYP3A4 or CYP2C9 inhibitors in the last week.I am taking warfarin but can switch to LMWH if needed.You have tested positive for hepatitis B, hepatitis C, or HIV.Your hemoglobin level is at least 9.0 grams per deciliter within two weeks before starting the trial.Your platelet count should be at least 100 x 10^9/L within two weeks before starting the trial.Your albumin level is at least 3.0 mg/dL within two weeks before starting the trial.Your ALT and/or AST levels are not more than 2.5 times the upper limit of normal, unless the increase is due to the presence of a tumor, in which case it can be up to 5 times the upper limit of normal. These tests should be done within two weeks before you start the trial.My cancer, originating in the eye, has spread to other parts.You are expected to live for at least 12 more weeks.I am 18 years old or older.I have Gilbert syndrome with high bilirubin levels but no liver damage.I have eye conditions in the eye not affected by uveal melanoma.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (defactinib, VS-6766)
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.
How many individuals are involved in this experiment?
"That is correct. The information available on clinicaltrials.gov verifies that this study, which was created on 1/26/2021, is looking for new participants. They need to enroll 18 patients from a single site."
Answered by AI
Does the drug VS-6766 have dangerous side effects?
"This drug's safety was given a score of 2 by our team at Power. This is due to the lack of clinical data supporting its efficacy, although there are multiple studies which suggest that it is safe for use."
Answered by AI
Is this experiment currently looking for participants?
"The trial, which was first announced on January 26th 2021 and last updated 28th of the same month, is currently looking for participants."
Answered by AI
Are there any other ongoing research projects that compare the effects of Raf/MEK Inhibitor VS-6766?
"This moment, there are 10 clinical trials underway investigating the efficacy of Raf/MEK Inhibitor VS-6766. However, none of these studies have reached Phase 3 yet. The majority of research surrounding this drug is based in San Diego, California; though, there are 1,561 total locations running related studies."
Answered by AI
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