A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, anOral EGFR Inhibitor, in Combination with Temozolomide in Patients with Newly DiagnosedGlioblastoma with Unmethylated MGMT Promoter and EGFRvIII
Contact:
NCT Number:
Protocol:
ACYY1139
Study Status:
Active/Enrolling
Population:
Adult
Phase:
II
The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat cancer better than using temozolomide alone. Silevertinib has not been approved by the Food and Drug Administration (FDA). Temozolomide is FDA approved but not in combination with silevertinib.
Are you Eligible? (Inclusion Criteria)
- Must be 18 years old or older - Cannot have major surgery within 4 weeks before first dose of study drug or scheduled for surgery during the study - Cannot have poorly controlled gastrointestinal disorders that may interfere with absorption of the study drug
Specialty Area(s)
Brain and Spinal Tumors, Immunotherapy
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032

