Spots Global Cancer Trial Database for SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors
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Trial Identification
Brief Title: SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors
Official Title: 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
Study ID: NCT03433183
Study Description
Brief 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.
Detailed Description: I. Primary Objective • To determine the clinical benefit rate of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST II. Secondary Objective(s) * To define and describe the toxicities of selumetinib in combination with sirolimus in patients with unresectable or metastatic NF1 associated or sporadic MPNST. * To assess the impact on intensity and pain interference and correlate to changes in clinical, imaging response and progression * To assess progression free and overall survival Selumetinib will be given orally 50mg twice daily continuously and sirolimus will be given orally 4mg once daily with a cycle 1 day 1 loading dose of 12mg. One cycle will be 28 days. Patients will be able to remain on treatment as long as they do not experience progressive disease or unacceptable toxicity. Stage 1 will require 7 patients, with no further accrual if 0 of 7 respond. If 1 or greater of the 7 patients respond, accrual will continue until 21 patients have been enrolled.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's National Medical Center, Washington, District of Columbia, United States
Johns Hopkins University, Baltimore, Maryland, United States
National Cancer Institute, Bethesda, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
Contact Details
Name: AeRang Kim, MD, PhD
Affiliation: Children's National Research Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Brigitte Widemann, MD
Affiliation: National Cancer Institute (NCI)
Role: PRINCIPAL_INVESTIGATOR
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