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PARP Inhibitor

PARP Inhibitor BGB-290 for Low Grade Glioma

Phase 1 & 2
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying BGB-290 and temozolomide to treat patients with brain tumors that have come back and have IDH1/2 mutations.

Eligible Conditions
  • Low Grade Glioma
  • Gliomas
  • Isocitrate Dehydrogenase
  • Glioblastoma
  • Isocitrate Dehydrogenase 1

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum tolerated dose (MTD)
Phase I: Percentage of participants with adverse events
Phase II: Tumor radiographic response
Secondary outcome measures
Duration of response
Percentage of participants with serious or life-threatening adverse events
Phase II: Overall survival (OS)
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Surgical ArmExperimental Treatment3 Interventions
Recurrent IDH1/2-mutant glioma (WHO grade II-IV) eligible for re-resection BGB-290: 60mg PO BID for 6 days AND day once day of surgery (day 7)
Group II: Phase 2: Arm B NOT Alkylator-resistantExperimental Treatment2 Interventions
Grade II-III:Recurrent IDH1/2-mutant glioma (WHO grades II/III) Failed TMZ OR another alkylator; >/=12 months since last treatment BGB290 + TMZ at dose combination established in Phase 1
Group III: Phase 2: Arm A Alkylator-resistantExperimental Treatment2 Interventions
Grade II-III: Recurrent IDH1/2-mutant glioma (WHO grades II/III) who have failed TMZ AND another alkylator BGB290 + TMZ at dose combination established in Phase 1
Group IV: Phase 1: Dose FindingExperimental Treatment2 Interventions
Recurrent IDH1/2-mutant grade II-III glioma: BGB290: Days 1-28, 60 mg PO BID TMZ: Days 1-28, 20 QD starting dose TMZ de-escalated treatment schedule if necessary (days 1-21; days 1-14; days 1-7) BGG held constant at 60mg PO BID
Group V: GBM ArmExperimental Treatment2 Interventions
Exploratory grade IV patients only BGB290 at Ph II dose for 7 days pre-surgery Progressed following RT + Chemo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PARP Inhibitor BGB-290
2020
Completed Phase 2
~60
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,754 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,840 Total Patients Enrolled

Media Library

BGB-290 (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03914742 — Phase 1 & 2
Low Grade Glioma Research Study Groups: Surgical Arm, Phase 2: Arm A Alkylator-resistant, Phase 2: Arm B NOT Alkylator-resistant, Phase 1: Dose Finding, GBM Arm
Low Grade Glioma Clinical Trial 2023: BGB-290 Highlights & Side Effects. Trial Name: NCT03914742 — Phase 1 & 2
BGB-290 (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03914742 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently a sign-up process for participants of this research experiment?

"This medical trial is no longer seeking patients. It was initially posted on March 1st 2020 and most recently updated on December 1st 2022. For those looking for alternative studies, there are presently 1611 clinical trials with glioblastoma recruiting participants and 211 trials searching for enrollees to test PARP Inhibitor BGB-290."

Answered by AI

Has research been conducted on the effectiveness of PARP Inhibitor BGB-290?

"Memorial Sloan Kettering Cancer Center was the first to conduct research on PARP Inhibitor BGB-290 back in 2002. That initial investigation has since blossomed into 333 completed trials and 211 ongoing studies, many of which are available at clinical sites around Los Angeles."

Answered by AI

How many individuals have volunteered to participate in this experiment?

"At this time, no new participants are being accepted into the clinical trial that was first posted on March 1st, 2020 and last updated December 1st 2022. However, 1611 trials concerning glioblastoma and 211 studies involving PARP Inhibitor BGB-290 are actively enrolling patients."

Answered by AI

What medical conditions has PARP Inhibitor BGB-290 been utilized to treat?

"Nitrosourea is commonly treated with PARP Inhibitor BGB-290, and this same pharmaceutical has been seen to have advantageous effects when treating advanced directives, refractory mycosis fungoides, and neuroblastoma."

Answered by AI

What core goals has this trial been designed to achieve?

"BeiGene, the study's sponsor, has outlined a two-year timeline for assessing primary and secondary outcomes. The principal measure is Phase I: Percentage of participants with adverse events. Other objectives include evaluating progression-free survival (PFS), overall survival (OS) and Percentage of participants with serious or life-threatening toxicities as defined by CTCAE version 5.0."

Answered by AI

How extensively is this experiment being implemented across various sites?

"The study is enrolling patients from 13 different medical centres, such as the University of California in Los Angeles, UAB Comprehensive Cancer Center in Birmingham and Cleveland Clinic Taussig Cancer Center in Cleveland."

Answered by AI

Is this the inaugural endeavor of its kind?

"The research into PARP Inhibitor BGB-290 commenced back in 2002, with a Phase 1 trial sponsored by Schering-Plough. This initial study involving 60 patients was followed up by the drug receiving its Phase 2 approval one year later. Currently, there are 211 trials being conducted across 40 countries and 986 cities worldwide concerning this medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations
2020. "BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03914742.
~11 spots leftby Apr 2025
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