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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Diffusion Pharmaceuticals Inc

Study Type Interventional
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
Hide Arm/Group Description

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
Arm/Group Title Trans Sodium Crocetinate Plus SOC
Hide Arm/Group Description

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

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
61
(22 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
9
  47.4%
Male
10
  52.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Hispanic or Latino
5
  26.3%
Not Hispanic or Latino
14
  73.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
17
  89.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
 100.0%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival will be calculated from randomization to the time of death from any cause
Time Frame All subjects will be followed for 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trans Sodium Crocetinate Plus SOC
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: Months
11.3
(5.1 to 19.4)
Time Frame Treatment Emergent Adverse Events (TEAE) were recorded if they started or worsened after the first dose of study treatment and within 30 days of the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trans Sodium Crocetinate Plus SOC
Hide Arm/Group Description

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

All-Cause Mortality
Trans Sodium Crocetinate Plus SOC
Affected / at Risk (%)
Total   14/19 (73.68%)    
Hide Serious Adverse Events
Trans Sodium Crocetinate Plus SOC
Affected / at Risk (%) # Events
Total   11/19 (57.89%)    
Blood and lymphatic system disorders   
Pancytopenia * 1  1/19 (5.26%)  1
Endocrine disorders   
Steroid withdrawal syndrome * 1  1/19 (5.26%)  1
Gastrointestinal disorders   
Diarrhoea * 1  1/19 (5.26%)  1
General disorders   
Gait disturbance * 1  1/19 (5.26%)  1
Asthenia * 1  1/19 (5.26%)  1
Pyrexia * 1  1/19 (5.26%)  1
Infections and infestations   
Pneumonia * 1  1/19 (5.26%)  1
Pyuria * 1  1/19 (5.26%)  1
Respiratory Syncytial virus infection * 1  1/19 (5.26%)  1
Injury, poisoning and procedural complications   
Fall * 1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Lactic Acidosis * 1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Muscular weakness * 1  1/19 (5.26%)  1
Nervous system disorders   
Cognitive disorder * 1  1/19 (5.26%)  1
Aphasia * 1  1/19 (5.26%)  1
Brain oedema * 1  1/19 (5.26%)  1
Cerebral haemorrhage * 1  1/19 (5.26%)  1
Depressed level of consciousness * 1  2/19 (10.53%)  2
Hydrocephalus * 1  1/19 (5.26%)  1
Intellectual disability * 1  1/19 (5.26%)  1
Lethargy * 1  1/19 (5.26%)  1
Paraesthesia * 1  1/19 (5.26%)  1
Seizure * 1  2/19 (10.53%)  2
Vasogenic cerebral oedema * 1  2/19 (10.53%)  2
Psychiatric disorders   
Confusional state * 1  1/19 (5.26%)  1
Mental status changes * 1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/19 (5.26%)  1
Cough * 1  1/19 (5.26%)  1
Pneumonia aspiration * 1  1/19 (5.26%)  1
Pulmonary embolism * 1  4/19 (21.05%)  4
Vascular disorders   
Deep vein thrombosis * 1  3/19 (15.79%)  3
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trans Sodium Crocetinate Plus SOC
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Thrombocytopenia * 1  7/19 (36.84%) 
Gastrointestinal disorders   
Constipation * 1  8/19 (42.11%) 
Diarrhoea * 1  4/19 (21.05%) 
Nausea * 1  5/19 (26.32%) 
Vomiting * 1  5/19 (26.32%) 
General disorders   
Fatigue * 1  10/19 (52.63%) 
Gait disturbance * 1  4/19 (21.05%) 
Oedema peripheral * 1  6/19 (31.58%) 
Injury, poisoning and procedural complications   
Fall * 1  4/19 (21.05%) 
Nervous system disorders   
Aphasia * 1  5/19 (26.32%) 
Headache * 1  7/19 (36.84%) 
Vasogenic cerebral oedema * 1  4/19 (21.05%) 
Psychiatric disorders   
Confusional state * 1  5/19 (26.32%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  4/19 (21.05%) 
Pulmonary embolism * 1  6/19 (31.58%) 
Vascular disorders   
Deep vein thrombosis * 1  5/19 (26.32%) 
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
The 100-206 trial was an open-label, dose-escalation safety run-in for what was originally planned as a larger randomized trial. 19 pts were enrolled to ensure that at least 8 pts completed the FDA-specified 24-mo. exposure period. At its Q3 2019 meeting, the DSMB found no adverse safety signal and recommended the trial continue as planned. However, the Sponsor did not have resources to fully support the randomized phase of the study and enrollment in the randomized phase was suspended.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President of Clinical Operations
Organization: Diffusion Pharmaceuticals Inc
Phone: 434-220-0718
EMail: clinicaltrials@diffusionpharma.com
Layout table for additonal information
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