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

Glioblastoma Clinical Trial

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

Clinical Trial Summary

This open-label study will evaluate 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 will receive TSC in the study. The objective of the study is to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.

Clinical Trial Description

The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients are to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease progression, QoL, and overall survival in adults when TSC is added to the standard of care regimen of radiation therapy and temozolomide. All patients will receive TSC in this study. The primary objective of the Phase 1 portion of the study is to evaluate the safety (DLT rate) and to define the dosing regimen of TSC for the larger Phase 2 study. The primary clinical endpoint is overall survival at 24 months and patients will be followed for up to 3 years. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01465347
Study type Interventional
Source Diffusion Pharmaceuticals LLC
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date February 2012
Completion date September 2016
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