Silevertinib + Temozolomide for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.
Specifically, this study is being done to find answers to the following questions:
* How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?
* What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?
* Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Silevertinib
- Temozolomide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles
temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles
Find a Clinic Near You
Who Is Running the Clinical Trial?
Black Diamond Therapeutics, Inc.
Lead Sponsor
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