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ACTIVE NOT RECRUITING
NCT04614909
EARLY_PHASE1

Study of Pamiparib in Newly Diagnosed and rGBM

Sponsor: Nader Sanai

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2021-01-11

Completion Date

2026-07

Last Updated

2025-02-28

Healthy Volunteers

No

Interventions

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.

Locations (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States