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Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects

NCT03393000 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-07-22

Study results available
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Summary

Open-label, randomized, controlled, phase 3 safety and efficacy registration trial.

Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care.

The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment.

Conditions

Interventions

DRUG

Trans Sodium Crocetinate plus SOC

Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide

OTHER

Standard of Care (SOC)

Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide

Sponsors & Collaborators

  • Diffusion Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Harry N Cook, RPH/MBA · Diffusion Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2020-11-06
Completion
2020-11-06
FDA Drug
Yes

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 NCT03393000 on ClinicalTrials.gov