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NCT01465347 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma
A Phase 1 study of Glioblastoma and Glioma, sponsored by Diffusion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 18
- Study locations
NCT01465347 is a Phase 1 study of Glioblastoma and Glioma that has completed, run by Diffusion Pharmaceuticals. The registered enrollment target is 59 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (46% lower). The trial reports 18 study locations across 15 states.
The verdict
NCT01465347, a Phase 1 study of Glioblastoma and Glioma, has completed, sponsored by Diffusion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 18
- Study locations
Study Summary
This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. All patients received TSC in the study. The objective of the study was to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.
Conditions Studied
Interventions
- DRUG Trans Sodium Crocetinate (TSC)
Study Locations (18)
California
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
Illinois
- Northwestern University Robert H. Lurie Comprehensive Cancer Center - Chicago
- Rush University Medical Center - Chicago
Texas
- Baylor University Medical Center - Dallas
- University of Texas Health Science Center Memorial Hermann Medical Center - Houston
Arizona
- St. Joseph's Medical Center Barrow Neurology Clinics - Phoenix
Arkansas
- University of Arkansas Winthrop P. Rockefeller Cancer Institute - Little Rock
District of Columbia
- The George Washington University Medical Center - Washington D.C.
Florida
- University of Florida McKnight Brain Institute - Gainesville
Georgia
- Emory University Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01465347
The ClinicalTrials.gov registry entry for NCT01465347 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (46% lower). The listed sponsor is Diffusion Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Trans Sodium Crocetinate (TSC) is the first listed.
NCT01465347 reports 18 study locations spanning 15 distinct geographic areas - top geographies include California, Illinois, Texas.
Frequently Asked Questions
What is clinical trial NCT01465347 about?
NCT01465347 is a clinical study titled "Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma". This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. All patients received TSC in the study. The objective of the study was to evaluate the effect of TSC on s...
What is the current status of trial NCT01465347?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2012-02. Estimated completion is 2016-02.
What conditions does trial NCT01465347 study?
This clinical trial studies the following conditions: Glioblastoma, Glioma, GBM.
What interventions are being tested in trial NCT01465347?
The interventions under investigation include: Trans Sodium Crocetinate (TSC) (DRUG).
Who is sponsoring clinical trial NCT01465347?
This trial is sponsored by Diffusion Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01465347 being conducted?
This trial has 18 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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