A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma - Trial NCT03150862
Access comprehensive clinical trial information for NCT03150862 through Pure Global AI's free database. This Early Phase 1 trial is sponsored by BeiGene USA, Inc. and is currently Completed. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 116 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
BeiGene USA, Inc.
BeiGene
Timeline & Enrollment
Early Phase 1
Jul 24, 2017
Mar 17, 2021
Primary Outcome
Phase 1b Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) as Assessed by CTCAE,Phase 1b Escalation Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as Assessed by CTCAE,Phase 1b Escalation Phase Arm C: Number of Participants With Clinically Relevant Changes in Vital Signs and Clinical Laboratory Measurements,Phase 2 Arm A: Modified Disease Control Rate (DCR) as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria,Phase 2 Arm C: Objective Response Rate (ORR) as Assessed Using RANO Criteria,Phase 1b Arm C: Number of Cycles of Treatment Received by Participants,Phase 1b Arm C: Average Dose Intensity of Pamiparib And TMZ Received Per Participant
Summary
The primary objective of this study is to evaluate the safety, efficacy and clinical activity
 of Pamiparib in combination with radiation therapy (RT) and/or temozolomide (TMZ) in
 participants with newly diagnosed or recurrent/refractory glioblastoma.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03150862
Non-Device Trial