NCT04614909

Study of Pamiparib in Newly Diagnosed and rGBM

A Phase 0/2 Clinical Trial of Pamiparib in Newly-Diagnosed and Recurrent Glioblastoma Patients

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Nader Sanai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma Multiforme, Adult

Interventions

Type	Name	Description
DRUG	Pamiparib	60mg administered orally BID for 4 days prior to surgical resection
DRUG	Olaparib	200mg administered orally BID for 4 days prior to surgical resection
RADIATION	Radiation therapy	Patients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care
DRUG	Temozolomide	Arm A and Arm B participants after RT is completed, will receive pamiparib in combination with TMZ (newly diagnosed participants). Arm C participants will receive olaparib with TMZ.

Timeline

• Start date: 2021-01-11
• Primary completion: 2024-07-26
• Completion: 2026-07-01
• First posted: 2020-11-04
• Last updated: 2025-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study