CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Selumetinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03433183
NCT03433183Phase 2Completed
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SARC031: A Phase 2 Trial of the MEK Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Combination With the mTOR Inhibitor Sirolimus for Patients With Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors

Sarcoma Alliance for Research through Collaboration·interventional·Posted Feb 14, 2018·Updated May 27, 2026

In Brief

A Phase 2 clinical trial evaluating Selumetinib and Sirolimus for Malignant Peripheral Nerve Sheath Tumors and Neurofibromatosis 1. Completed, enrolled 21 participants across 5 sites.

Detailed Summary

To determine the clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic neurofibromatosis type 1 (NF1) associated or sporadic MPNST.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Peripheral Nerve Sheath Tumors, Neurofibromatosis 1
CountriesUnited States
CollaboratorsUnited States Department of Defense, AstraZeneca

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 14, 2018
Enrollment StartOct 2, 2019
Primary CompletionJun 22, 2022
Study CompletionOct 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.4 years ago

Interventions

Selumetinibdrug

Selumetinib (AZD6244) is an oral selective inhibitor of the mitogen-activated protein kinase (MEK) 1/2 currently in development for adult malignancies, pediatric low-grade gliomas and NF1 plexiform neurofibromas. MEK is a critical kinase in the mitogen activated protein (MAP) kinase signal transduction pathway for many growth factor receptors that provide growth signals to cancer cells.

Sirolimusdrug

Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus and inhibitor of mammalian Target of Rapamycin (mTOR) serine threonine kinase, which plays a critical role in regulating cellular energy sensing, growth and metabolism.