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COMPLETED Phase 1

Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma

NCT01465347 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 59 participants
Start Date 2012-02
Est. Completion 2016-02
Phase Phase 1

Sponsor

Diffusion Pharmaceuticals

3 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Diffusion Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01465347 reports 18 study locations spanning 15 distinct geographic areas — top geographies include California, Illinois, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01465347?

The interventions under investigation include: Trans Sodium Crocetinate (TSC) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01465347?

This trial is sponsored by Diffusion Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial