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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01465347

Public ClinicalTrials.gov record NCT01465347. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 5:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-label Phase 1/2 (Safety Lead-in) Study of Trans Sodium Crocetinate (TSC) With Concomitant Treatment of Fractionated Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Patients to Evaluate Safety and Efficacy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01465347
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Diffusion Pharmaceuticals Inc
Industry
Enrollment
59 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2012 (Type not available)
Primary completion
Nov 2015 (Actual)
Completion
Feb 2016 (Actual)
Last update posted
Jul 14, 2017

2012 – 2016

United States locations

U.S. sites
18
U.S. states
15
U.S. cities
16
Facility City State ZIP Site status
St. Joseph's Medical Center Barrow Neurology Clinics Phoenix Arizona 85013 —
University of Arkansas Winthrop P. Rockefeller Cancer Institute Little Rock Arkansas 72205 —
USC/Norris Comprehensive Cancer Center Los Angeles California 90033 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
The George Washington University Medical Center Washington D.C. District of Columbia 20037 —
University of Florida McKnight Brain Institute Gainesville Florida 32611 —
Emory University Winship Cancer Institute Atlanta Georgia 30322 —
Northwestern University Robert H. Lurie Comprehensive Cancer Center Chicago Illinois 60611 —
Rush University Medical Center Chicago Illinois 60612 —
University of Kentucky Markey Cancer Center Lexington Kentucky 40536 —
North Shore University Hospital Manhasset New York 11030 —
Forsyth Regional Cancer Center Winston-Salem North Carolina 27103 —
Penn State University Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
Medical University of South Carolina Charleston South Carolina 29425 —
Baylor University Medical Center Dallas Texas 75246 —
University of Texas Health Science Center Memorial Hermann Medical Center Houston Texas 77030 —
UVA Health Sciences Center Emily Couric Clinical Cancer Center Charlottesville Virginia 22908 —
Froedtert & Medical College of Wisconsin Cancer Center Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01465347, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 14, 2017 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01465347 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →