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Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

Phase 1
18 Years
Open (Enrolling)
Recurrent Malignant Glioma

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Trial Information

Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients

Inclusion Criteria:

1. Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary

2. Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to

3. Prior radiotherapy

4. Prior Temozolomide treatment

5. Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more
days before study start (greater than or equal to 42 days if nitrosourea was

6. Karnofsky performance status greater than or equal to 60%

7. Full recovery (< grade 1) from the toxic effects of any earlier intervention and a
minimum of 28 days from the administration of any investigational agent

8. Adequate renal, liver and bone marrow function:

- Leukocytes >3,000/mcL

- Absolute neutrophil count >1,500/mcL

- Platelets >100,000/mcL

- Total bilirubin within normal limits

- AST / ALT (SGPT) <2.5 x ULN

- Creatinine within normal limits

9. Patients must be >_18 years of age

Exclusion Criteria:

1. Second primary malignancy (except adequately treated basal cell carcinoma of the
skin). Patients who had another malignancy in the past, but have been free of active
disease for more than 2 years, are eligible

2. Have received treatment within the last 28 days with a drug that has not received
regulatory approval for any indication at the time of study entry

3. Serious concomitant systemic disorders (for example, active infection or abnormal
electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the
investigator, would compromise the safety of the patient and his/her ability to
complete the study

4. Patients with moderate or severe renal impairment (calculated creatinine clearance of
< 60 mL/min)

5. Patients with sodium, potassium, or creatinine serum electrolytes > grade 2.

6. Patients with PT/PTT above the upper limit of normal

7. Screening ECG abnormality documented by the investigator as medically significant

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Adverse events per patient

Outcome Description:

The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Randy Jensen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

September 2015

Related Keywords:

  • Recurrent Malignant Glioma
  • Glioma



Huntsman Cancer Institute Salt Lake City, Utah  84112