SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for… (NCT03433183) | Clinical Trial Compass
CompletedPhase 2
SARC031: MEK Inhibitor Selumetinib (AZD6244) in Combination With the mTOR Inhibitor Sirolimus for Patients With Malignant Peripheral Nerve Sheath Tumors
United States21 participantsStarted 2019-10-02
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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 st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined two drugs — selumetinib, a MEK inhibitor, and sirolimus, an mTOR inhibitor — for MPNST patients; based on the completed results, did this combination show meaningful clinical benefit, and is it something worth considering in my situation?
2Since this was a Phase 2 trial, what do the completed results tell us about both the effectiveness and the safety profile of this drug combination, and are there risks I should be aware of before thinking about this approach?
3My tumor may be NF1-associated or sporadic — does the data from this trial suggest the combination worked differently depending on whether the MPNST was linked to neurofibromatosis 1 or not, and which category does my tumor fall into?
4Before exploring this combination, should I first pursue standard treatments like surgery or chemotherapy, or does my situation — particularly if my tumor is unresectable or metastatic — make this kind of targeted approach more relevant to discuss now?
5Since this trial has completed, are the results published or accessible, and are there any ongoing or follow-up studies using selumetinib or sirolimus for MPNST that might be a better fit for where I am in my treatment journey?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Benefit Rate of Selumetinib in Combination With Sirolimus in Patients With Unresectable or Metastatic NF1 Associated or Sporadic MPNST.
Timeframe: Up to 6 months
Trial details
NCT IDNCT03433183
SponsorSarcoma Alliance for Research through Collaboration