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.
Who Can Participate?
Eligibility
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.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, multicenter, open label, two parts clinical study to evaluate the efficacy and safety of safusidenib erbumine in patients with isocitrate dehydrogenase 1 (IDH1) mutant glioma
Principal Investigator
Katherine
Peters
Protocol Number
PRO00113232
NCT ID
NCT05303519
Phase
II
Enrollment Status
Open to Enrollment