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Kinase Inhibitor

Selumetinib + Cabozantinib for Plexiform Neurofibroma (NF113 Trial)

Phase 1

Waitlist Available

Research Sponsored by Girish Dhall, MD

Eligibility Criteria Checklist

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

Must have

Participants must be ≥16 years of age at the time of study entry

Participants must have a BSA of 1.0 m2 or greater

Must not have

Concomitant anticoagulation with specific agents

Evidence of optic pathway or other glioma, high-grade glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of combining two drugs, selumetinib and cabozantinib, in patients with NF1 who are 16 years or older and have progressive

Who is the study for?

This trial is for individuals aged 16 or older with a condition called Neurofibromatosis type 1 (NF1) who have progressive and/or symptomatic Plexiform Neurofibromas (PN). Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

What is being tested?

The study tests the combination of two oral drugs, Selumetinib and Cabozantinib, for treating PN in NF1 patients. It's conducted in three phases: dose escalation to find safe levels (Phase 1), expanded testing at these doses (Phase 1b), and then using the established safe dose on more people (Phase 2).

What are the potential side effects?

While specific side effects aren't listed here, both Selumetinib and Cabozantinib as monotherapies may cause various reactions depending on individual tolerance. Common drug-related side effects could include digestive issues, skin changes, high blood pressure, fatigue among others.

Eligibility Criteria

Inclusion Criteria

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

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I am 16 years old or older.

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My body surface area is at least 1.0 square meters.

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My organs are functioning well.

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I have been diagnosed with NF1 according to the latest criteria.

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My nerve problems are getting worse or causing major health issues.

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I am able to care for myself but cannot do normal activities or work.

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I don't expect to have major surgery within 3 months after joining.

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My nerve tumors can be measured using MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking blood thinners.

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I have a brain or nerve tumor that needs treatment.

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I am experiencing side effects from previous radiation therapy.

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I have a GI condition that could lead to holes or abnormal connections.

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I have been treated for a serious brain or nerve tumor in the last year.

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I cannot swallow pills.

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I do not have serious heart conditions like heart failure or severe valve problems.

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I do not have serious eye conditions like CSR, RVO, or uncontrolled glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of participants that experienced a dose limiting toxicity when taking cabozantinib and selumetinib together.

To define and describe the toxicities of the combination therapy with cabozantinib and selumetinib

Secondary study objectives

Evaluating objective response rate

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: Phase 1 cabozantinib and selumetinib combinationExperimental Treatment2 Interventions

The first enrolled participants will start at dose level one with a starting dose of cabozantinib of 20 mg once daily and a starting dose of selumetinib of 15 mg/m2 twice daily. The doses of drug a participant receives will depend on when the participant enrolls on the study. The first group of participants (3 - 6) will receive selumetinib and cabozantinib at half of the typical dose when given separately. If the side effects are tolerable, the second group of 3 to 6 participants will receive a higher dose of selumetinib and cabozantinib. If the drug combination is well-tolerated, there could be up to 5 groups (maximum 6 participants in each group) with each group taking an increased dose from the previous group's dose. If this is tolerated, then this will be the recommended dose of this combination for the Phase 1b of this study. If the side effects are too severe, the participants will receive a lower dose of both drugs.

0 / 16Eligibility criteria met