This trial is active, not recruiting.

Conditions glioblastoma, gbm, glioma, high grade glioma
Treatment trans sodium crocetinate (tsc)
Phase phase 1/phase 2
Sponsor Diffusion Pharmaceuticals LLC
Start date February 2012
End date September 2015
Trial size 59 participants
Trial identifier NCT01465347, DP100-202


This open-label study will evaluate the safety and efficacy of TSC when dosed concomitantly with the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in adults. All patients will receive TSC in the study. The objective of the study is to evaluate the effect of TSC on survival and tumor response in patients with GBM while establishing an acceptable patient risk profile.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
trans sodium crocetinate (tsc)
TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.

Primary Outcomes

Overall Survival
time frame: 24 months

Secondary Outcomes

Quality of Life (QoL)
time frame: Baseline, Week 6, Week 10, Week 18, Week 26, Week 52, Week 74 through Week 110

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Aged at least 18 years of age; male or female. A patient who is 70 years of age or older may be considered for enrollment after review of patient clinical and laboratory data by the Protocol Medical Monitor. - Histologically confirmed diagnosis of GBM. - Contrast enhancing disease on MRI within 21 days prior to Screening. - Karnofsky score (KPS) of ≥ 60 at Screening. - No prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed. - Within 2 weeks of Baseline visit, 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. - Sexually active patients must use an acceptable method of contraception while receiving doses of study medication. - Females of childbearing potential must have a negative serum or urine pregnancy test at Screening and have additional pregnancy tests during study. Exclusion Criteria: - Pt. who cannot undergo MRI. - Pregnant or lactating. - Serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety. - Pt. receiving concurrent chemotherapeutics or investigational agents within 30 days of Baseline assessments, including gliadel wafers or gliasite application.

Additional Information

Official title Open-label Phase 1/2 (Safety Lead-in) Study of Trans Sodium Crocetinate (TSC) With Concomitant Treatment of Fractionated Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Patients to Evaluate Safety and Efficacy
Description The overall objectives of this Phase 1/2 clinical study in newly diagnosed GBM patients are to evaluate the safety and tolerability, efficacy, PK profile, PFS/time to disease progression, QoL, and overall survival in adults when TSC is added to the standard of care regimen of radiation therapy and temozolomide. All patients will receive TSC in this study. The primary objective of the Phase 1 portion of the study is to evaluate the safety (DLT rate) and to define the dosing regimen of TSC for the larger Phase 2 study. The primary clinical endpoint is overall survival at 24 months and patients will be followed for up to 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Diffusion Pharmaceuticals LLC.