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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: Completed Phase 1 study of Glioblastoma and Glioma, sponsored by Diffusion Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)
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 |
What the finished NCT01465347 record still lists
NCT01465347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (46% lower).
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 lists 18 locations in 15 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01465347's enrollment target sits among peer trials
59 79th of 199 higher than 121 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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