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Study of Pamiparib in Newly Diagnosed and rGBM

NCT04614909 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

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.

RADIATION

Radiation therapy

Patients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care

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

Sponsors & Collaborators

  • Barrow Neurological Institute

    collaborator OTHER

  • Ivy Brain Tumor Center

    collaborator OTHER

  • BeiGene

    collaborator INDUSTRY

  • Nader Sanai

    lead OTHER

Principal Investigators

  • Nader Sanai, MD · Director, Ivy Brain Tumor Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2023-07-21
Completion
2025-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614909 on ClinicalTrials.gov