You are here

SARC031 IS NOW OPEN FOR ACCRUAL!

FAQS FOR 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.

  1. What is the purpose of this study? The purpose of this study is to learn if the combination of an experimental drug called selumetinib with another drug called sirolimus when given to people with unresectable or metastatic NF1 associated or sporadic MPNST will provide clinical benefit, such as reduce tumor size or improve pain level.
  2. What is RECIST criteria? RECIST (Response Evaluation Criteria in Solid Tumors) is a commonly used standard to determine whether a patient’s tumor(s) is responding to therapy. Based on the change in the size of tumor(s) measured on CT, MRI or other radiology studies, physicians use RECIST to classify tumor response into different categories e.g. tumor is unchanged in size (stable), tumor is shrinking (partial response), tumor has disappeared (complete response), or tumor is growing (progression).
  3. Is biopsies part of this clinical trial? The biopsies are optional. Biopsies may be performed to obtain tumor tissue for research during the trial. Please speak with a study doctor about the timing of biopsies, the type of biopsies and risks from biopsies.
  4. What are the most common side effects related to Selumetinib and Sirolimus? The most common side effects related to selumetinib are diarrhea, nausea, swelling of the body, tiredness, acne, decreased appetite, constipation, high blood pressure, rash, pain or aches in joints, lowered ability to fight infection, swelling/redness in the mouth, anemia, hyperlipidemia and hypercholesterolemia.
  5. How long would I receive treatment on this study? You would continue to receive selumetinib and sirolimus until the progression of your disease, unacceptable side effects caused by study medicines, you choose to stop treatment, your doctor feels you should not continue on the study, you become pregnant or another illness prevents you from continuing on the study.
  6. Can I participate in a trial with my local doctor? In order to be treated in the clinical trial of Selumetinib with Sirolimus, you must enroll and be treated at one of the designated approved oncology centers involved in this clinical trial. Please contact SARC at www.sarctrials.org to find the nearest center to you. For more information you can call or email SARC (sarc@sarctrials.org or 734-930-7600). This trial is also listed at: https://clinicaltrials.gov/ct2/show/NCT03433183
  7. Can patients from outside US participate? Patients from outside the US may participate in the trial but they must be evaluated, enrolled and treated by one of the approved oncology centers for this trial. Currently, only centers in the US are approved to conduct this trial.