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

NCT01465347 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-07-14

Study results available
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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

Interventions

DRUG

Trans Sodium Crocetinate (TSC)

TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.

Sponsors & Collaborators

  • Diffusion Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • David R. Jones, M.D. · Diffusion Pharmaceuticals Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-11-30
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01465347 on ClinicalTrials.gov