Clinical trial NCT04614909: Study of Pamiparib in Newly Diagnosed and rGBM
Official title: A Phase 0/2 Clinical Trial of Pamiparib in Newly-Diagnosed and Recurrent Glioblastoma Patients
Conditions: Glioblastoma
Glioblastoma Multiforme
Glioblastoma Multiforme, Adult
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).
Interventions:
description: 60mg administered orally BID for 4 days prior to surgical resection
name: Pamiparib
type: Drug
description: 200mg administered orally BID for 4 days prior to surgical resection
name: Olaparib
type: Drug
description: Patients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care
name: Radiation therapy
type: Radiation
description: 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.
name: Temozolomide
type: Drug
Study arms:
design_group_description: 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.
design_group_title: Arm A Newly-diagnosed Glioblastoma Participant treated with Pamiparib
design_group_type: Experimental
design_group_description: 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.
design_group_title: Arm B Recurrent Glioblastoma Participant treated with Pamiparib
design_group_type: Experimental
design_group_description: 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.
design_group_title: Arm C Recurrent Glioblastoma Participant treated with Olaparib
design_group_type: Experimental
Sponsor: St. Joseph's Medical Center, Inc.
Collaborators: Barrow Neurological Institute
BeOne Medicines Ltd.
Drug name mappings:
name: 奥拉帕利
lang: CN
name: Olaparib
lang: EN
name: オラパリブ
lang: JP
name: 帕米帕利
lang: CN
name: Pamiparib
lang: EN
name: 替莫唑胺
lang: CN
name: Temozolomide
lang: EN
name: テモゾロミド
lang: JP