Veliparib for Glioblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Glioblastoma+2 MoreVeliparib - Drug
Eligibility
3 - 25
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a combination of drugs as a potential treatment for newly diagnosed malignant glioma. The drugs being studied are veliparib, radiation therapy, and temozolomide.

Eligible Conditions
  • Glioblastoma
  • Anaplastic Astrocytoma
  • Malignant Glioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 5.5 years

Up to 5.5 years
Biomarker analysis
Event free survival (EFS)
Objective response
Overall survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (radiation therapy, veliparib, temozolomide)
1 of 1

Experimental Treatment

115 Total Participants · 1 Treatment Group

Primary Treatment: Veliparib · No Placebo Group · Phase 2

Treatment (radiation therapy, veliparib, temozolomide)Experimental Group · 3 Interventions: Veliparib, Temozolomide, Radiation Therapy · Intervention Types: Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Veliparib
Not yet FDA approved
Temozolomide
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5.5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,093 Previous Clinical Trials
41,143,205 Total Patients Enrolled
303 Trials studying Glioblastoma
22,400 Patients Enrolled for Glioblastoma
Matthias A KarajannisPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age 3 - 25 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient must have pre-operative and post-operative brain MRI with and without contrast
Results are negative for H3 K27M by IHC.
You have a negative result for BRAF mutation by NGS.
You are between 3 and 21 years of age.
Stratum 1 was closed to accrual on January 24, 2020.
You have an ANC of 1,000 or more neutrophils per microliter of blood.

Who else is applying?

What state do they live in?
California50.0%
North Carolina50.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
Carolinas Medical Center/Levine Cancer Institute100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%