Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma
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|ClinicalTrials.gov Identifier: NCT01465347|
Recruitment Status : Completed
First Posted : November 4, 2011
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma GBM Glioma||Drug: Trans Sodium Crocetinate (TSC)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||February 2016|
Experimental: TSC 0.25 mg/kg for 9 or 18 doses
This was an open-label, sequential-cohort, dose-escalation study in two phases. Phase 1 was a safety run-in evaluating Trans Sodium Crocetinate (TSC) in 3 subjects who received 3 doses per week for 3 weeks (9 doses in total). Phase 2 engaged 56 subjects who received 3 doses per week for 6 weeks (18 doses in total). TSC was consistently dosed at 0.25mg/kg in both phases.
Drug: Trans Sodium Crocetinate (TSC)
TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
Other Name: TSC
- Dose Limiting Toxicities (DLTs) [ Time Frame: During phase 1 ]Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)
- Overall Survival [ Time Frame: 6, 12, 18, 24 months ]Participants in phase 2 (18 dose group, 6 weeks treatment with TSC) were monitored for up to 3 years (last follow-up - February 16, 2016). Overall Survival (OS) was defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death. The OS analyses were performed using the Kaplan-Meier estimate method. The OS rates at 6, 12, 18 and 24 months were estimated. Median OS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. The length of OS (in months) was calculated as follows: date of death or censored - date of surgery or definitive biopsy / 30.4375.
- Progression-Free Survival (PFS) [ Time Frame: 6,12,18, 24 months ]The PFS analyses were performed using the Kaplan-Meier estimate method. The PFS rates at 6, 12, 18 and 24 months were estimated. Median PFS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. Time to disease progression (in months) was calculated as follows: date of event* or censoring - date of surgery or definitive biopsy / 30.4375; *event = first tumor progression or death.
- Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction [ Time Frame: From Baseline to Week 110 ]The sum of the product of the diameters of the tumor (using recorded tumor diameter measurements made from brain MRI images) was used to express tumor size. Results were summarized for actual and percentage change from baseline. Individual subjects results were listed, including tumor volume and tumor response from independent reviewers. Investigator data were listed but not used in the analysis. Percent response (according to independent reviewer assessments) by percentage tumor reduction from tumor resection or definitive biopsy to the last MRI were summarized.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465347
|Study Chair:||David R. Jones, M.D.||Diffusion Pharmaceuticals Inc|