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Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) With Concomitant Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Diffusion Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT01465347
First received: November 2, 2011
Last updated: October 6, 2013
Last verified: October 2013

November 2, 2011
October 6, 2013
February 2012
September 2015   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01465347 on ClinicalTrials.gov Archive Site
Quality of Life (QoL) [ Time Frame: Baseline, Week 6, Week 10, Week 18, Week 26, Week 52, Week 74 through Week 110 ] [ Designated as safety issue: No ]
Evaluate QoL and daily functioning using EORTC QLQ-C30/BN20 and Karnofsky Performance Score(KPS)
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) With Concomitant Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM)
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glioblastoma
  • GBM
  • Glioma
  • High Grade Glioma
Drug: Trans Sodium Crocetinate (TSC)
TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
Experimental: TSC 0.25 mg/kg for 9 or 18 doses
Intervention: Drug: Trans Sodium Crocetinate (TSC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
59
September 2016
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01465347
DP100-202
Yes
Diffusion Pharmaceuticals LLC
Diffusion Pharmaceuticals LLC
Not Provided
Not Provided
Diffusion Pharmaceuticals LLC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP