Safusidenib Phase 2 study in IDH1 mutant glioma - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

IDH1-mutant glioma

¿Quién puede participar en el Estudio?

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.

Grupo etario
Adultos

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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
Investigador Principal
Katherine B. Peters, MD, PhD
Especialista en neuro-oncología
Número de Protocolo
IRB: PRO00113232
NCT: NCT05303519
Fase
Phase II
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
Apoye la investigación de Duke Health o rinda homenaje a un ser querido con un regalo conmemorativo.
Contribuya a Duke Health