CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Temozolomide +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01514201
NCT01514201Phase 2Completed

A Phase I/II Study of ABT-888, An Oral Poly(ADP-ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, Followed by ABT-888 and Temozolomide, in Children With Newly Diagnosed Diffuse Pontine Gliomas (DIPG)

National Cancer Institute (NCI)·interventional·Posted Jan 23, 2012·Updated Aug 13, 2019

In Brief

A Phase 2 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, and 4 other interventions for Anaplastic Astrocytoma and 12 related conditions. Completed, enrolled 66 participants across 12 sites.

Detailed Summary

This phase I/II trial studies the side effects and the best dose of veliparib when given together with radiation therapy and temozolomide and to see how well they work in treating younger patients newly diagnosed with diffuse pontine gliomas. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing. Giving veliparib with radiation therapy and temozolomide may kill more tumor cells.

Study Details

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMar 28, 2018
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 14.4 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo 3D-CRT

Intensity-Modulated Radiation Therapyradiation

Undergo IMRT

Laboratory Biomarker Analysisother

Optional correlative studies

Pharmacological Studyother

Correlative studies

Temozolomidedrug

Given PO

Veliparibdrug

Given PO