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MEK Inhibitor

Selumetinib and Sirolimus for Peripheral Nerve Sheath Tumor

Phase 2
Waitlist Available
Led By Brigitte Widemann, MD
Research Sponsored by Sarcoma Alliance for Research through Collaboration
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up progression-free survival (pfs) is defined as the duration of time from the start of treatment to the time of objective progression or death. [time frame: up to 4 years]
Awards & highlights

Study Summary

This trial will look at whether selumetinib in combination with sirolimus can help patients with neurofibromatosis type 1 who have a type of tumor called an MPNST.

Eligible Conditions
  • Malignant Peripheral Nerve Sheath Tumor
  • Neurofibromatosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~progression-free survival (pfs) is defined as the duration of time from the start of treatment to the time of objective progression or death. [time frame: up to 4 years]
This trial's timeline: 3 weeks for screening, Varies for treatment, and progression-free survival (pfs) is defined as the duration of time from the start of treatment to the time of objective progression or death. [time frame: up to 4 years] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST.
Secondary outcome measures
Assess the impact on pain interference
Pain
Define and describe the toxicities of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Selumetinib and SirolimusExperimental Treatment2 Interventions
A Simon's two-stage phase 2 trial of MEK inhibitor selumetinib in combination with the mTOR inhibitor sirolimus to determine the safety and clinical benefit in patients with unresectable or metastatic MPNSTs. Both agents will be given orally on an empty stomach. Selumetinib will be given orally at a dose of 50mg twice daily continuously. Sirolimus will be given orally at a dose of 4mg once daily with a cycle 1 day 1 loading dose of 12mg. Each cycle will be considered 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2050
Sirolimus
2013
Completed Phase 4
~2750

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,765 Total Patients Enrolled
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,933 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,173 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors
2019. "SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03433183.
~4 spots leftby Apr 2025
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