What is the Purpose of this Study?
The purpose of this study is to determine whether combining an experimental drug called silevertinib with temozolomide (a standard treatment) after surgery and radiotherapy helps treat cancer better than using temozolomide alone in people with newly diagnosed glioblastoma (GBM, a type of brain cancer). Participants in this study have a tumor with a gene alteration in epidermal growth factor receptor (EGFR); this alteration in EGFR leads to the abnormal growth of cells and tumor development. Silevertinib is designed to block a signal important to the growth of certain tumors. Temozolomide is a drug that fights cancer cells by damaging DNA (the genetic material of cells), which could cause the tumor cell to die. Researchers aim to determine how much of the study drugs (silevertinib combined with temozolomide) should be given to patients. The study will also evaluate the side effects of the drugs. Procedures include physical examination, blood and urine lab sample collection, and imaging scans. The study has 2 parts. In Part 1, participants will receive silevertinib combined with temozolomide to determine the safety and best dose of the drugs. In Part 2, participants will be randomly assigned to 1 of 2 treatment groups. One group will receive silevertinib plus temozolomide, and the other group will receive temozolomide only. The combination of silevertinib with temozolomide is considered investigational.
Eligibility
- * Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).
- * Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).
- * For Part 1 (Safety Lead-in) ONLY: EGFR alterations.
- * For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan
More about this Clinical Trial
What is the full name of this clinical trial?
BDTX-1535-201: A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination with Temozolomide in Patients with Newly Diagnosed Glioblastoma with Unmethylated MGMT Promoter and EGFRvIII *