CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
vorinostat +1 moredrug
Likely dose
vorinostat 400mgfrom 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/NCT01266031
NCT01266031Phase 2Completed
CompareCT.gov

Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma

National Cancer Institute (NCI)·interventional·Posted Dec 24, 2010·Updated Jul 31, 2018

In Brief

A Phase 2 clinical trial evaluating vorinostat and bevacizumab for Malignant Glioma and Recurrent Glioblastoma. Completed, enrolled 96 participants across 1 site.

Detailed Summary

The goal of this Phase I portion of this clinical research study is to find the highest tolerable dose of bevacizumab with or without vorinostat, that can be given to patients with malignant gliomas. The safety of these drug combinations will also be studied. The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Glioma, Recurrent Glioblastoma
CountriesUnited States
CollaboratorsM.D. Anderson Cancer Center, Genentech, Inc., Merck Sharp & Dohme LLC, Brain Tumor Trials Collaborative, Ohio State University, Northwestern University, UF Health Cancer Center at Orlando Health, Baylor Health Care System, MUSC Hollings Cancer Center, University of Utah Health System, University of Washington, Henry Ford Health System, Columbia University, Rush University Medical Center, Endeavor Health, The Cleveland Clinic, University of North Carolina, Chapel Hill, Washington University School of Medicine, Texas Oncology-Austin

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartJul 12, 2011
Primary CompletionJun 30, 2015
Study CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 15.5 years ago

Interventions

vorinostatdrug

Vorinostat 400mg/day will be administered on day 1 to 7 and day 15 to 21 orally on a 28 day cycle in the arm with combination of vorinostat and bevacizumab. Vorinostat will be administered orally. Vorinostat capsules should not be opened or crushed and must be administered whole.

bevacizumabdrug

Bevacizumab 10mg/kg will be administered on day 1 and 15 intravenously on a 28 day cycle in both arms.