Malignant Peripheral Nerve Sheath TumorsPhase 2NCT03433183
SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors
A Phase 2 study testing Selumetinib and Sirolimus in people with Malignant Peripheral Nerve Sheath Tumors and Neurofibromatosis 1, run by Sarcoma Alliance for Research through Collaboration at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Malignant Peripheral Nerve Sheath Tumors, Neurofibromatosis 1
- What is being tested?
- Selumetinib and Sirolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Oct 2019to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12 years of age
- Patients with unresectable or metastatic histologically confirmed sporadic or NF1 associated MPNST.
- Patients must have measureable disease by RECIST.
- Patients must have experienced progression after one or more prior regimens of cytotoxic chemotherapy. Patients who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic chemotherapy is felt to be in the best interest for the patient by the local investigator will also be eligible.
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study.
- No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study entry.
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- The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks prior to study entry.
- The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 4 weeks prior to study entry.
- The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry.
- The last dose of radiation to more than 25% of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study entry. The last dose of all other local palliative (limited port) radiation must be at least 2 weeks prior to study entry.
- At least 2 months post-autologous stem cell transplant or at least 3 months post-allogeneic transplant and recovered from toxicities without evidence of graft versus host disease and on stable doses of immunosuppressive medications if required.
- The last dose of colony stimulating factors, such as filgrastim, sargramostim, and erythropoietin, must be at least 1 week prior to study entry, the last dose of long-acting colony stimulating factors, such as pegfilgrastim, must be at least 2 weeks prior to study entry.
- No other anti-cancer therapy (chemotherapy, biological therapy, radiation therapy) is permitted.
- Karnofsky performance level ≥ 50%.
- Patients who are unable to walk because of paralysis or motor weakness, but who are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.
- Peripheral absolute neutrophil count (ANC) of ≥1000/μL
- Platelet count ≥75,000/μL (transfusion independent (no transfusion within at least 7 days prior to enrollment)
- Total bilirubin must be ≤ 1.5 times the upper limit of normal (ULN)
- SGPT (ALT) must be ≤ 3.0 times ULN
- Serum creatinine ≤ ULN or creatinine clearance >60 ml/min/1.73 m2
- Serum triglyceride level ≤300 mg/dL and serum cholesterol level ≤ 300 mg/dL (Patient may be on lipid-lowering medicine)
- Normal ejection fraction by ECHO or cardiac MRI >55%
- QTcF ≤ 450ms
- Fertile men and women of childbearing potential must agree to use an effective method of birth control.
- Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression or stable disease at 4 weeks.
Who cannot join
- Patients receiving other anti-cancer agents are not eligible.
- Patients who cannot swallow whole pills.
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (for example cyclosporine). Topical or inhaled corticosteroids are allowed.
- Patients should not receive immunizations with attenuated live vaccines within four weeks of study entry or during study period.
- Any recent major surgery within a minimum of 4 weeks, with the exception of surgical placement for vascular access, or minor surgery (excluding tumor biopsies) within 14 days.
- Patients who any known severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
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- Severely impaired lung function defined as spirometry and DLCO that is 50% of the normal predicted value corrected for hemoglobin and alveolar volume and/or O2 saturation that is 88% or less at rest on room air. For patients who do NOT have respiratory symptoms (e.g. dyspnea at rest, known requirement for supplemental oxygen), pulmonary function test is not required.
- Cardiac conditions as follows:
- Uncontrolled hypertension (blood pressure ≥150/95 mmHg despite medical therapy).
- Acute coronary syndrome within 6 months prior to starting treatment
- Uncontrolled angina despite medical therapy
- Symptomatic heart failure NYHA Class II-IV prior or current cardiomyopathy, or severe valvular disease
- Prior or current cardiomyopathy
- Uncontrolled Type 1 or 2 diabetes as defined by fasting serum glucose >1.5 x ULN
- Uncontrolled infection
- Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or renal tubular acidosis.
- Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of small bowel, symptomatic inflammatory bowel disease, or ulcerative colitis, or partial or complete bowel obstruction.
- Ophthalmological conditions as follows:
- Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy (CSR) or retinal vein occlusion
- Intraocular pressure (IOP) > 21 mmHg or uncontrolled glaucoma
- Supplementation with vitamin E greater than 100% of the daily recommended dose.
- Hypersensitivity to active or inactive excipients of rapamycins (sirolimus, temsirolimus or everolimus) or selumetinib or drugs with similar chemical structures or class to sirolimus or selumetinib.
- Patients unwilling or unable to comply with the protocol.
- Seville orange, star fruit, grapefruit and their juices, and St. John's Wort use are not allowed while on study.
- Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment.
- Exposure to specific substrates of drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate washout periods (a minimum of 5 x reported elimination half-life) before the first dose of study treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21287
National Cancer Institute
Bethesda, Maryland, 20892
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Washington University
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
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
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.
Read the detailed description
- 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.
- Being tested
- Selumetinib, Sirolimus
- Medical subject headings
- Neurofibrosarcoma, Neurofibromatosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelumetinibDrug
Also called AZD6244
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
Also called Rapamycin
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.
| Study group | Role | What they receive |
|---|---|---|
| Selumetinib and Sirolimus | Experimental | 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. Receives: Drug: Selumetinib; Drug: Sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
An evaluable patient will be classified as a responder if the patient achieves a partial response (PR), complete response (CR) or stable disease (SD) ≥ 4 cycles.
Measured: Up to 6 months
Secondary outcomes (4)
Progression Free (PFS) and Overall Survival (OS)
Determined using the Kaplan-Meier method with PFS at important time points reported along with 95% two sided confidence intervals.
Measured: PFS is the duration of time from the start of treatment to the time of objective progression or death whichever happens first up to 4 years. OS is the duration of time from the start of treatment to the time of death; assessed up to 4 years.
Define and Describe the Toxicities of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
Treatment-emergent adverse events occurring after initiation of selumetinib in combination with sirolimus were assessed and graded according to CTCAE v5.0. The safety population included all participants who received at least one dose of study treatment.
Measured: Up to 6 months
Assess the Impact on Pain Interference
Change in Pain Interference (PROMIS) from baseline to pre-cycle 2 (calculated as the score pre-cycle 2 minus the score at baseline). Positive values indicate increasing pain.
Higher scores indicate worse pain The statistical test assesses if there is a significant change in pain interference from baseline to pre-cycle 2
Wilcoxon signed-rank test
T-scores are standardized to the general population with a mean of 50 and standard deviation of 10. Higher scores indicate worse anxiety symptoms. A T-score of 55-60 indicates mild pain interference, 60-70 indicates moderate pain interference, and 70-80 indicates severe pain interference.
Measured: Up to 6 months
Assess the Impact on Pain Severity
Change in Pain Intensity, as assessed on the numerical rating scale 11, from baseline to pre-cycle 2 (calculated as the score pre-cycle 2 minus the score at baseline). Positive values indicate increasing pain.
Higher scores indicate worse pain The statistical test assesses if there is a significant change in pain intensity from baseline to pre-cycle 2 Wilcoxon signed-rank test
The Numerical Rating Scale-11 (NRS-11) is a self-report segmented 11-point numeric scale that assesses pain severity. It consists of a horizontal line with 0 representing "no pain" at the right end of the line and 10 representing "worst pain you can imagine" at the left end.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start2 Oct 2019
- Primary completion22 Jun 2022
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Peripheral Nerve Sheath TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 MPNST
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- AeRang Kim, MD, PhD, Principal investigator, Children's National Research InstituteBrigitte Widemann, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433183
- Sponsor's protocol ID
- SARC031
- Other IDs
- CDMRP-NF150092
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2018
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03433183
- Acronym / sponsor ID
- SARC031
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sarcoma Alliance for Research through CollaborationUniversity, hospital or other
- Collaborators
- United States Department of Defense, AstraZeneca
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 MPNST
| Arm | Type | Receives |
|---|---|---|
| Selumetinib and Sirolimus | Experimental | Drug: Selumetinib, Drug: SirolimusA 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- Age ≥ 12 years of age
- Patients with unresectable or metastatic histologically confirmed sporadic or NF1 associated MPNST.
- Patients must have measureable disease by RECIST.
- Patients must have experienced progression after one or more prior regimens of cytotoxic chemotherapy. Patients who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic chemotherapy is felt to be in the best interest for the patient by the local investigator will also be eligible.
- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study.
Key exclusion criteria (26 listed)
- Patients receiving other anti-cancer agents are not eligible.
- Patients who cannot swallow whole pills.
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (for example cyclosporine). Topical or inhaled corticosteroids are allowed.
- Patients should not receive immunizations with attenuated live vaccines within four weeks of study entry or during study period.
- Any recent major surgery within a minimum of 4 weeks, with the exception of surgical placement for vascular access, or minor surgery (excluding tumor biopsies) within 14 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelumetinibAlso: AZD6244Selumetinib (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. | Drug | Selumetinib and Sirolimus |
| SirolimusAlso: RapamycinSirolimus 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. | Drug | Selumetinib and Sirolimus |
Primary outcome
Clinical Benefit Rate of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
Time frame: Up to 6 months
An evaluable patient will be classified as a responder if the patient achieves a partial response (PR), complete response (CR) or stable disease (SD) ≥ 4 cycles.
4 secondary outcomes
Progression Free (PFS) and Overall Survival (OS)
Time frame: PFS is the duration of time from the start of treatment to the time of objective progression or death whichever happens first up to 4 years. OS is the duration of time from the start of treatment to the time of death; assessed up to 4 years.
Define and Describe the Toxicities of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
Time frame: Up to 6 months
Assess the Impact on Pain Interference
Time frame: Up to 6 months
Assess the Impact on Pain Severity
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AeRang Kim, MD, PhD principal investigator
Children's National Research Institute
Brigitte Widemann, MD principal investigator
National Cancer Institute (NCI)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selumetinib and Sirolimus in people with Malignant Peripheral Nerve Sheath Tumors and Neurofibromatosis 1, run by Sarcoma Alliance for Research through Collaboration at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST. (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.