Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects (INTACT)
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ClinicalTrials.gov Identifier: NCT03393000 |
Recruitment Status :
Terminated
(Business decision on behalf of the Sponsor.)
First Posted : January 8, 2018
Results First Posted : July 22, 2021
Last Update Posted : July 22, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Glioblastoma |
Interventions |
Drug: Trans Sodium Crocetinate plus SOC Other: Standard of Care (SOC) |
Enrollment | 19 |
Recruitment Details | Based on the request from FDA for a run-in period prior to initiating the randomized portion of the trial, only the run-in was completed; the randomized trial was never initiated. All results reported are specific to the run-in period. |
Pre-assignment Details |
Arm/Group Title | Trans Sodium Crocetinate Plus SOC |
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Trans Sodium Crocetinate 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 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 |
Period Title: Overall Study | |
Started | 19 [1] |
Completed | 5 [2] |
Not Completed | 14 |
Reason Not Completed | |
Death | 11 |
Withdrawal by Subject | 2 |
Physician Decision | 1 |
[1]
23 subjects screened
[2]
19 subjects treated
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Arm/Group Title | Trans Sodium Crocetinate Plus SOC | |
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Trans Sodium Crocetinate 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 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 |
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Overall Number of Baseline Participants | 19 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 19 participants | |
61
(22 to 70)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
Female |
9 47.4%
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Male |
10 52.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
Hispanic or Latino |
5 26.3%
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Not Hispanic or Latino |
14 73.7%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
1 5.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
17 89.5%
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More than one race |
0 0.0%
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Unknown or Not Reported |
1 5.3%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 19 participants |
19 100.0%
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Name/Title: | Vice President of Clinical Operations |
Organization: | Diffusion Pharmaceuticals Inc |
Phone: | 434-220-0718 |
EMail: | clinicaltrials@diffusionpharma.com |
Responsible Party: | Diffusion Pharmaceuticals Inc |
ClinicalTrials.gov Identifier: | NCT03393000 |
Other Study ID Numbers: |
100-206 |
First Submitted: | December 26, 2017 |
First Posted: | January 8, 2018 |
Results First Submitted: | May 18, 2021 |
Results First Posted: | July 22, 2021 |
Last Update Posted: | July 22, 2021 |