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NCT01402063 · ClinicalTrials.gov registry record · Phase 2
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
A Phase 2 study of Glioblastoma Multiforme, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 9
- Study locations
NCT01402063: Completed Phase 2 study of Glioblastoma Multiforme, sponsored by Brown University.
NCT01402063 is a Phase 2 study of Glioblastoma Multiforme that has completed, run by Brown University. The registered enrollment target is 63 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (34% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01402063, a Phase 2 study of Glioblastoma Multiforme, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
MRI response evaluated by RANO criteria * Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response. * Partial Response (PR): Decrease of \> 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG PPX (CT2103)
Study Locations (9)
Pennsylvania
- PSU - Hershey
- Thomas Jefferson University Cancer Center - Philadelphia
California
- UCSD Cancer Center - La Jolla
Maine
- Maine Medical Center - Scarborough
Massachusetts
- UMASS Medical Center Cancer Center - Worcester
New York
- SUNY Medical Center - Syracuse
Rhode Island
- Rhode Island Hospital - Providence
Texas
- UT Southwestern Cancer Center - Dallas
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01402063 record still lists
NCT01402063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT01402063 lists 9 locations in 8 states (Pennsylvania, California, Maine).
Frequently Asked Questions
What is clinical trial NCT01402063 about?
NCT01402063 is a clinical study titled "PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation". 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.
What is the current status of trial NCT01402063?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2011-09. Estimated completion is 2015-06.
What conditions does trial NCT01402063 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT01402063?
The interventions under investigation include: Temozolomide (DRUG), PPX (CT2103) (DRUG).
Who is sponsoring clinical trial NCT01402063?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01402063 being conducted?
This trial has 9 study locations across California, Maine, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01402063's enrollment target sits among peer trials
63 27th of 88 higher than 61 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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