CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Trans Sodium Crocetinate (TSC)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01465347
NCT01465347Phase 2Completed
CompareCT.gov

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

Diffusion Pharmaceuticals Inc·interventional·Posted Nov 4, 2011·Updated Jul 14, 2017

In Brief

A Phase 2 clinical trial evaluating Trans Sodium Crocetinate (TSC) for Glioblastoma and 2 related conditions. Completed, enrolled 59 participants across 18 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma, GBM, Glioma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2011
Enrollment StartFeb 1, 2012
Primary CompletionNov 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.7 years ago

Interventions

Trans Sodium Crocetinate (TSC)drug

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