drugset / Trial / NCT04614909
Study of Pamiparib in Newly Diagnosed and rGBM
Phase 0
Completed
50 enrolled
Nader Sanai
Barrow Neurological Institute · collabBeiGene · collabIvy Brain Tumor Center · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, single-center Phase 0/2 study that will enroll up to 30 participants with newly diagnosed (N=12) and recurrent glioblastoma (N=18). The trial will be composed of a Phase 0 component (subdivided into Arm A, Arm B, and Arm C), and an Exploratory Phase 2 component. Participants with tumors demonstrating a PK response in the Phase 0 component of the study will graduate to an exploratory Phase 2 component that combines therapeutic dosing of pamiparib plus fractionated radiotherapy (for unmethylated MGMT promoter newly-diagnosed cases), pamiparib plus fractionated radiotherapy (for recurrent cases) or Olaparib plus fractionated radiotherapy (recurrent cases).
Timeline
- Start
- 2021-01-11
- Primary completion
- 2023-07-21
- Completion
- 2025-05-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 200 mg | Oral |
| Subject | Pamiparib | Small molecule | 60 mg | Oral |
| Background | Temozolomide | Small molecule | — | — |