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MEK Inhibitor
SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors
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
No Placebo-Only Group
Summary
This trial tests a combination of two oral medications, selumetinib and sirolimus, for patients with severe NF1-related or sporadic tumors that cannot be removed by surgery or have spread. The drugs work together to block cancer growth signals and stop cell multiplication.
Eligible Conditions
- Malignant Peripheral Nerve Sheath Tumor
- Neurofibromatosis
Timeline
Screening ~ 3 weeks3 visits
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]
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]
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST.
Secondary study objectives
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 moreAwards & 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: 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
~2080
Sirolimus
2013
Completed Phase 4
~2750
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,411 Previous Clinical Trials
289,123,572 Total Patients Enrolled
Sarcoma Alliance for Research through CollaborationLead Sponsor
25 Previous Clinical Trials
1,933 Total Patients Enrolled
United States Department of DefenseFED
913 Previous Clinical Trials
334,285 Total Patients Enrolled