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Early Phase Study Evaluating MEK and MDM2 Inhibition in Patients With NF1 and MPNST (MEKMDM2 Trial)

Phase 1 & 2
Waitlist Available
Led By AeRang Kim, MD, PhD
Research Sponsored by AeRang Kim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* AGE: Part A and C: ≥ 18 years of age AGE: Part B: ≥12 years (minimum BSA ≥0.55m2)
* MEASURABLE DISEASE: Patients must have measurable disease by RECISTv1.1. Baseline radiologic scans must be performed within 4 weeks of starting treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 months
Awards & highlights
No Placebo-Only Group

Summary

This is a phase 0/1/2, multi-site study to evaluate the MEK inhibitor Selumetinib with the MDM2 Inhibitor APG-115 in patients with Neurofibromatosis Type 1 and pre-malignant and malignant peripheral nerve sheath tumors

Eligible Conditions
  • Peripheral Nerve Sheath Tumor
  • Neurofibromatosis
  • Benign Tumors

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 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 treated patients with adverse events as determined by the common criteria for adverse version 5 (CTCAEv5).
Tumor response by imaging using RECISTv1.1
Secondary study objectives
Percent apoptosis and tumor proliferation

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: APG-115 and SelumetinibExperimental Treatment2 Interventions
There is only one arm. It is combination therapy of APG-115 and Selumetinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APG-115
2016
Completed Phase 1
~50
Selumetinib
2010
Completed Phase 2
~2080

Find a Location

Who is running the clinical trial?

Children's National Research InstituteOTHER
223 Previous Clinical Trials
258,370 Total Patients Enrolled
AeRang KimLead Sponsor
2 Previous Clinical Trials
16 Total Patients Enrolled
AeRang Kim, MD, PhDPrincipal InvestigatorChildren's National Research Institute
6 Previous Clinical Trials
76 Total Patients Enrolled
~30 spots leftby Oct 2027
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