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

NCT03393000 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 100-206
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival will be calculated from randomization to the time of death from any cause

  All subjects will be followed for 24 months

Study Arms (2)

Trans Sodium Crocetinate plus SOC

EXPERIMENTAL

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

Drug: Trans Sodium Crocetinate plus SOC

Standard of Care (SOC)

ACTIVE COMPARATOR

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: Standard of Care (SOC)

Interventions

Trans Sodium Crocetinate plus SOC DRUG

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

Also known as: Trans Sodium Crocetinate (TSC) plus Standard of Care

Trans Sodium Crocetinate plus SOC

Standard of Care (SOC) OTHER

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

Also known as: Standard of Care

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Diffusion Pharmaceuticals Inc: lead

Study Sites (13)

University of California

Irvine, California, 92868, United States

Location

Scott Peak, M.D.

Redwood City, California, 94063, United States

Location

John Wayne Cancer Institute @ Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Piedmont Cancer

Atlanta, Georgia, 30318, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

UNM Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Scott Lindhorst, M.D.

Charleston, South Carolina, 29425, United States

Location

Neuro Oncology Associates

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

trans-sodium crocetinate; Standard of Care

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

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.

Results Point of Contact

• Title: Vice President of Clinical Operations
• Organization: Diffusion Pharmaceuticals Inc

clinicaltrials@diffusionpharma.com

434-220-0718

Study Officials

• Harry N Cook, RPH/MBA

  Diffusion Pharmaceuticals Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, controlled

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 8, 2018
• Study Start: January 16, 2018
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: July 22, 2021
• Results First Posted: July 22, 2021

Record last verified: 2021-07

Locations

US (13)