Trial Outcomes & Findings for Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects (NCT NCT03393000)
NCT ID: NCT03393000
Last Updated: 2021-07-22
Results Overview
Overall survival will be calculated from randomization to the time of death from any cause
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
All subjects will be followed for 24 months
Results posted on
2021-07-22
Participant Flow
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.
Participant milestones
| Measure |
Trans Sodium Crocetinate Plus SOC
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 Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Trans Sodium Crocetinate Plus SOC
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 Study
Death
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
Baseline characteristics by cohort
| Measure |
Trans Sodium Crocetinate Plus SOC
n=19 Participants
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
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All subjects will be followed for 24 monthsOverall survival will be calculated from randomization to the time of death from any cause
Outcome measures
| Measure |
Trans Sodium Crocetinate Plus SOC
n=19 Participants
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 Survival (OS)
|
11.3 Months
Interval 5.1 to 19.4
|
Adverse Events
Trans Sodium Crocetinate Plus SOC
Serious events: 11 serious events
Other events: 19 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Trans Sodium Crocetinate Plus SOC
n=19 participants at risk
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
|
|---|---|
|
Nervous system disorders
Cognitive disorder
|
5.3%
1/19 • Number of events 1 • 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.
|
|
General disorders
Gait disturbance
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • 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.
|
|
General disorders
Asthenia
|
5.3%
1/19 • Number of events 1 • 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.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Infections and infestations
Pyuria
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Infections and infestations
Respiratory Syncytial virus infection
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Aphasia
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Brain oedema
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Cerebral haemorrhage
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Depressed level of consciousness
|
10.5%
2/19 • Number of events 2 • 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.
|
|
Nervous system disorders
Hydrocephalus
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Intellectual disability
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Lethargy
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Nervous system disorders
Seizure
|
10.5%
2/19 • Number of events 2 • 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.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
10.5%
2/19 • Number of events 2 • 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.
|
|
Psychiatric disorders
Confusional state
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Psychiatric disorders
Mental status changes
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
5.3%
1/19 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
21.1%
4/19 • Number of events 4 • 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.
|
|
Vascular disorders
Deep vein thrombosis
|
15.8%
3/19 • Number of events 3 • 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.
|
Other adverse events
| Measure |
Trans Sodium Crocetinate Plus SOC
n=19 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.8%
7/19 • 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.
|
|
Gastrointestinal disorders
Constipation
|
42.1%
8/19 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
4/19 • 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.
|
|
Gastrointestinal disorders
Nausea
|
26.3%
5/19 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
26.3%
5/19 • 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.
|
|
General disorders
Fatigue
|
52.6%
10/19 • 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.
|
|
General disorders
Gait disturbance
|
21.1%
4/19 • 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.
|
|
General disorders
Oedema peripheral
|
31.6%
6/19 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
21.1%
4/19 • 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.
|
|
Nervous system disorders
Aphasia
|
26.3%
5/19 • 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.
|
|
Nervous system disorders
Headache
|
36.8%
7/19 • 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.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
21.1%
4/19 • 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.
|
|
Psychiatric disorders
Confusional state
|
26.3%
5/19 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
4/19 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
31.6%
6/19 • 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.
|
|
Vascular disorders
Deep vein thrombosis
|
26.3%
5/19 • 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.
|
Additional Information
Vice President of Clinical Operations
Diffusion Pharmaceuticals Inc
Phone: 434-220-0718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60