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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Open-label, randomized, controlled, phase 3 safety and efficacy registration trial.
Subjects will be randomized at baseline to the standard of care for first-line treatment of glioblastoma plus Trans Sodium Crocetinate (TSC) or the standard of care.
The standard of care for GBM will consist of temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest followed by 6 cycles of post-radiation temozolomide treatment.
Condition or disease | Intervention/treatment | Phase |
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Glioblastoma | Drug: Trans Sodium Crocetinate plus SOC Other: Standard of Care (SOC) | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Open-label, randomized, controlled |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects |
Actual Study Start Date : | January 16, 2018 |
Actual Primary Completion Date : | November 6, 2020 |
Actual Study Completion Date : | November 6, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: 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
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Drug: 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
Other Name: Trans Sodium Crocetinate (TSC) plus Standard of Care |
Active Comparator: Standard of Care (SOC)
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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Other: Standard of Care (SOC)
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
Other Name: Standard of Care |
- Overall Survival (OS) [ Time Frame: All subjects will be followed for 24 months ]Overall survival will be calculated from randomization to the time of death from any cause

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects who are at least 18 to 70 years of age
- Have histologically confirmed GBM
- The only surgical consideration is biopsy. Subjects who had gross total resection, partial resection and/or debulking are excluded.
- Measurable (>10mm x 10mm) contrast enhancing disease.
- Limited disturbance of tumor during biopsy.
- Surgical and pathology reports that document surgery was limited to biopsy and histologic confirmation.
- Life expectancy of at least 3 months.
- Subjects must have a Karnofsky score (KPS) of ≥ 60 at Screening.
- Glucocorticoid therapy allowed.
- Tumor Treatment Field (TT Fields) therapy allowed.
- If female, the subject must have a negative serum or urine pregnancy test at Screening unless meeting non-productive potential criteria.
- Subjects must have hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.0g/dL, creatinine ≤ 1.7mg/dL, total bilirubin ≤ 1.5mg/dL, blood urea nitrogen (BUN) within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm.
- The subject or subject's medical power of attorney has provided written consent to participate in this study.
Exclusion Criteria:
- Subjects who had gross total tumor resection, partial resection, and/or debulking surgery.
- Subjects must not have had prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy.
- Subject who is pregnant or lactating.
- Subject with a serious concurrent infection or medical illness that would jeopardize the ability of the subject to receive study treatment with reasonable safety.
- Subject who cannot undergo MRI.
- Subject receiving concurrent chemotherapeutics or investigational agents within 30 days of study entry, including gliadel wafers or gliasite application.
- Subjects with other uncontrolled medical conditions, e.g. myocardial infarction, cerebrovascular accident, diabetes or hypertension.
- Subjects diagnosed with another malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix.
- CTCAE Version 4, Grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393000
United States, California | |
University of California | |
Irvine, California, United States, 92868 | |
Scott Peak, M.D. | |
Redwood City, California, United States, 94063 | |
John Wayne Cancer Institute @ Providence Saint John's Health Center | |
Santa Monica, California, United States, 90404 | |
United States, Georgia | |
Piedmont Cancer | |
Atlanta, Georgia, United States, 30318 | |
John B. Amos Cancer Center | |
Columbus, Georgia, United States, 31904 | |
United States, Minnesota | |
Abbott Northwestern Hospital | |
Minneapolis, Minnesota, United States, 55407 | |
United States, New Jersey | |
John Theurer Cancer Center | |
Hackensack, New Jersey, United States, 07601 | |
United States, New Mexico | |
UNM Comprehensive Cancer Center | |
Albuquerque, New Mexico, United States, 87102 | |
United States, New York | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
Mount Sinai Hospital | |
New York, New York, United States, 10029 | |
United States, Oregon | |
Providence Portland Medical Center | |
Portland, Oregon, United States, 97213 | |
United States, South Carolina | |
Scott Lindhorst, M.D. | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
Neuro Oncology Associates | |
Dallas, Texas, United States, 75246 |
Study Director: | Harry N Cook, RPH/MBA | Diffusion Pharmaceuticals Inc |
Documents provided by Diffusion Pharmaceuticals Inc:
Responsible Party: | Diffusion Pharmaceuticals Inc |
ClinicalTrials.gov Identifier: | NCT03393000 |
Other Study ID Numbers: |
100-206 |
First Posted: | January 8, 2018 Key Record Dates |
Results First Posted: | July 22, 2021 |
Last Update Posted: | July 22, 2021 |
Last Verified: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Vitamin A Trans-sodium crocetinate Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Anticarcinogenic Agents Antineoplastic Agents Vitamins Micronutrients |