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NCT03150862

A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma

A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination With Radiation Therapy (RT) and/or Temozolomide (TMZ) in Subjects With First-line or Recurrent/Refractory Glioblastoma
BeiGene USA, Inc.·Early Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Brain and Central Nervous System Tumors
Drug/Device/Intervention
Pamiparib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
BeiGene USA, Inc.
Funder
BeiGene
Location
Tucson,Los Angeles,San Francisco,Denver,Boston,Boston,Detroit,Kansas City,Saint Louis,New York,Cleveland,Columbus,Oklahoma City,Hershey,Philadelphia,Nashville,Salt Lake City,Charlottesville,Rotterdam,, Netherlands,Switzerland,United States of America
Timeline & enrollment
Phase
Early Phase 1
Start date
Jul 24, 2017
End date
Mar 17, 2021
Enrollment
116 participants
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
Malignant neoplasm: Overlapping lesion of brain and other parts of central nervous systemMalignant neoplasm: Central nervous system, unspecifiedBenign neoplasm of brain and other parts of central nervous systemMalignant neoplasm of brainSecondary malignant neoplasm of other and unspecified parts of nervous system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03150862
Type
Non-Device Trial
About this record

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.