ONC201 in recurrent high-grade glioma
Recruiting
18 years - 99 years
All
Phase
2
5 participants needed
1 Location
Brief description of study
This is a phase II, open-label study of ONC201 in adults with recurrent high- grade glioma. Subjects for this study will be
recruited from the patient population that present to the Penn Brain
tumor center- Department of Neurosurgery or Department of Medicine
division of Hematology/ Oncology for evaluation and treatment of their
brain tumors.
Subjects will be age 18 or older with a histone H3 K27M mutant glioma that has progressed after radiation therapy. The primary objective is to estimate the overall response rate (ORR) of ONC201 in this population.
In addition, secondary objects will be to assess the safety, toxicities and tolerability of ONC201 in adults with recurrent high-grade glioma and estimate the median PFS, PFS at 2 and 6 months (progression-free survival at 6 months), median OS, and median duration of response.
This study is sponsor by Oncoceutics, INC
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: glioma
-
Age: 18 years - 99 years
-
Gender: All
Adults Subjects (age 18 or older) with a histone H3 K27M mutant glioma that has progressed after radiation therapy.
Updated on
04 Aug 2024.
Study ID: 832987