Clinical Trial DRUG PLX108-08
- An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination with Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
- Principal Investigator
- Jeffrey Raizer
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG PLX108-08
- The purpose of this research study is to assess the safety and efficacy of PLX3397 (the study drug) in people diagnosed with a type of brain cancer called gliblastoma multiforme (GBM).
- This study is for patients who have been diagnosed with GMB. GBM is the most frequent type of brain tumor, accounting for about 12% to 15% of all brain tumors. In this is a study research are looking at an experimental study drug, PLX3397, for the treatment of GBM. “Experimental” means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA).
Some of the eligibility criteria include:
- Participants must have a diagnosis of GBM or gliosarcoma.
- Participants must have had surgery to remove all or part of the cancer within 5 weeks of starting the study.
- Participants must be 18 or older.
- Description of Treatment
- All study participants will take capsules of the study drug by mouth twice a day. After taking study drug twice a day for the first 7 days, participants will begin radiation therapy on day 8 and continue once a day 5 times per week for 6 weeks. Participants will continue to take study drug twice a day while being given radiation therapy. In addition to study drug and radiation therapy, participants will also receive another drug, Temozolomide. It is a capsule taken by mouth taken once a day for 42 days (6 weeks) beginning on day 8 (same day as beginning radiation therapy). Then, after a 28-day break, it may be taken once a day for 5 days in a row, followed by a 23-day break before repeating the next dosage cycle. The doctor will decide how many times participants should repeat the treatment cycles.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase II Study of the Efficacy of Hypofractionated Radiation Therapy with Bevacizumab and Temozolomide Followed by Maintenance Temozolomide and Bevacizumab for Recurrent High-Grade Gliomas
- A Phase II, open label, clinical trial of pre-surgical and adjuvant treatment of recurrent malignant glioma with Tremelimumab and Durvalumab (MEDI4736) alone and in combination to determine immunologic changes from treatment.
last updated: 28-Sep-16 01:50 AM
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