Safusidenib Phase 2 study in IDH1 mutant glioma
What is the Purpose of this Study?
In this study, people will be randomly placed into one of two groups, like flipping a coin. One group will take a new medicine called safusidenib, and the other group will take a fake pill called a placebo. They will take the pills twice a day in 28-day cycles. Doctors will check their health and the size of their brain tumor with regular MRI scans, blood tests, and check-ups. People will also answer questions about how they feel. The study will keep going until the tumor grows or there is another reason to stop.
IDH1-mutant glioma
Who Can Participate in the Study?
People can join this study if they are 18 years or older and have a type of brain tumor called Grade 3 or Grade 4 astrocytoma with an IDH1 mutation. They must have finished radiation and between 6 to 12 rounds of a medicine called temozolomide. Their cancer must not have gotten worse, and they must feel well enough to take part in the study.
What is Involved?
This study is testing a new medicine called safusidenib to see if it can help people with a type of brain tumor called IDH1-mutant glioma. Researchers want to find out if safusidenib can safely keep the tumor from growing or coming back after standard treatment.