Study of Pamiparib in Newly Diagnosed and rGBM

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nader Sanai
Study ID
NCT04614909
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Glioblastoma
  • Glioblastoma Multiforme
  • Glioblastoma Multiforme, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pamiparib — DRUG
    60mg administered orally BID for 4 days prior to surgical resection
  • Olaparib — DRUG
    200mg administered orally BID for 4 days prior to surgical resection
  • Radiation therapy — RADIATION
    Patients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care
  • Temozolomide — DRUG
    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.

Study Details

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).

Key Dates

Start date
Jan 11, 2021
Status verified
May 2026
Primary completion
Jul 21, 2023
Completion
May 28, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A Newly-diagnosed Glioblastoma Participant treated with Pamiparib
    Participants undergoing resection for a presumed newly diagnosed glioblastoma (nGBM) will be treated with pamiparib for 4 days prior to surgical resection. Patients who proceed to Phase 2 will receive pamiparib administered orally BID continuously in combination with 6-7 weeks of radiation therapy and pamiparib in combination with TMZ in the maintenance phase.
  • Experimental: Arm B Recurrent Glioblastoma Participant treated with Pamiparib
    Recurrent glioblastoma (rGBM) patients who are scheduled for surgery and expected to receive postoperative fractionated radiotherapy (RT) will be treated with pamiparib for 4 days prior to surgical resection. Patients who proceed to Phase 2 will receive pamiparib administered orally BID continuously in combination with 6-7 weeks of radiation therapy and pamiparib in combination with TMZ in the maintenance phase.
  • Experimental: Arm C Recurrent Glioblastoma Participant treated with Olaparib
    Arm C will be an exploratory arm in recurrent glioblastoma patients (rGBM) treated with Olaparib for 4 days prior to surgical resection. Patients who proceed to Phase 2 will receive olaparib administered orally BID continuously in combination with 6-7 weeks of radiation therapy and pamiparib in combination with TMZ in the maintenance phase.

Primary Outcome Measure

Systemic plasma PK profile parameters [ Time Frame: Day 4 Intra-operative sample ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-

Find similar trials in Phoenix, AZ

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
St. Joseph's Hospital and Medical Center· Phoenix, AZ

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