CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
PPX (CT2103) +1 moredrug
Likely dose
PPX (CT2103) 50 mg/m2from 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/NCT01402063
NCT01402063Phase 2Completed
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PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study

Brown University·interventional·Posted Jul 26, 2011·Updated Feb 17, 2020

In Brief

A Phase 2 clinical trial evaluating PPX (CT2103) and Temozolomide for Glioblastoma Multiforme. Completed, enrolled 63 participants across 9 sites.

Detailed Summary

To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma Multiforme
CountriesUnited States
CollaboratorsRhode Island Hospital, Milton S. Hershey Medical Center, University of Washington, University of Massachusetts, Worcester, MaineHealth, University of California, San Diego, Thomas Jefferson University

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2011
Enrollment StartSep 1, 2011
Primary CompletionApr 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.9 years ago

Interventions

PPX (CT2103)drug

XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.

Temozolomidedrug

XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum