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

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

Participant Flow

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
Arm/Group Description	Trans Sodium Crocetinate plus the S...
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

Baseline Characteristics

Arm/Group Title		Trans Sodium Crocetinate Plus SOC
Arm/Group Description		Trans Sodium Crocetinate plus the S...
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
Baseline Analysis Population Description		[Not Specified]
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
United States		19 100.0%

Outcome Measures

1.Primary Outcome


Title	Overall Survival (OS)
Description	Overall survival will be calculated from randomization to the time of ...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Trans Sodium Crocetinate Plus SOC
Arm/Group Description:	Trans Sodium Crocetinate plus the S...
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)

Adverse Events

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
Arm/Group Description	Trans Sodium Crocetinate plus the S...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

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.

More Information

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

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