Study of Cabozantinib With Selumetinib for Plexiform Neurofibromas
This study is looking at a combination of two oral medications, cabozantinib and selumetinib, for people aged 16 and older with Neurofibromatosis 1 (NF1) and plexiform neurofibromas (PNs). PNs are tumors that can cause problems like pain or disfigurement. Researchers want to see if taking these two drugs together is safe and what side effects might occur. The study will also look at how well the combination works to treat PNs. You must have a diagnosis of NF1 to join. The study plans to enroll 30 participants, but its current status is unclear.
- Study design
- This is an open-label, dose escalation study, meaning you and your doctors will know which medications you are receiving. Up to 6 participants will be enrolled at each dose level to evaluate safety.
- What's involved
- You will take cabozantinib once a day and selumetinib twice a day, both on an empty stomach. The specific dose will depend on when you join the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects and safety for 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Cabozantinib With Selumetinib for Plexiform Neurofibromas
At a glance
Conditions
Where it's being run
6 sites across 6 statesStudy leadership
- Girish Dhall, MD · STUDY_DIRECTOR · University of Alabama at Birmingham
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- The number of participants that experienced a dose limiting toxicity when taking cabozantinib and selumetinib together.12 months
The phase 1 uses a modified Rolling 6 design to test up to 5 dose level combinations of selumetinib and cabozantinib. In this design, six participants can be enrolled at a given dose level and then evaluated for dose limiting toxicity (DLT) within the DLT window. The DLT window is defined as 16 weeks in this study based on the long half-life of cabozantinib and the desire to have maximum confidence about long-term tolerability of the combination prior to proceeding to the next dose level. Enrollment will start at dose level one and enrollment to the next dose level will occur when 3/3, 4/4, 5/5, 5/6 or 6/6 participants have completed 16 weeks of therapy without DLT. From 6 to 30 participants, depending on the number enrolled at each dose level, will be enrolled for the Rolling 6 design evaluation of DLT.
- To define and describe the toxicities of the combination therapy with cabozantinib and selumetinib12 months
Adverse events based on the NCI Common Terminology Criteria (CTC) version 5.0