OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma

Inclusion Criteria:

- Patients have newly diagnosed histologically proven WHO grade III or grade IV
Glioblastoma Multiforme (GBM).

- Patients at initial presentation of GBM must undergo an adequate surgical resection of
the primary lesion; patients must be registered within 49 days (7 weeks) of the
surgery.

- Patients must have available and be willing to submit a minimum of five unstained
slides tumor tissue specimens from the GBM surgery or open biopsy for MGMT status
analysis and molecular profile analysis.

- ECOG performance status within 0 - 2

- Full recovery (< grade 1) from the adverse events associated with prior surgery or any
earlier intervention and a minimum of 28 days from the administration of any
investigational agent

- Adequate renal, liver and bone marrow function: Leukocytes >3,000/mcL; Absolute
neutrophil count >1,500/mcL; Platelets >100,000/mcL; AST / ALT (SGPT) <2.5 x ULN;
Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except Gilbert's
Syndrome, who must have a total bilirubin < 3.0 mg/dL); Creatinine within normal
limits

- Patients must be ≥ 18 years of age

- Patients must be willing to have blood draws for PK analysis

- All patients must have a CT or MRI of the brain within 14 days prior to registration.
The brain CT or MRI should be performed with intravenous contrast (unless
contraindicated).

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent for this protocol in accordance with institutional
and federal guidelines.

- Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and
progression-free survival evaluation;

- Female patient, if of childbearing potential, has a negative serum pregnancy test
within 72 hours of taking study medication and agrees to abstain from activities that
could result in pregnancy from enrollment through 120 days after the last dose of
study treatment

- Male patient agrees to use an adequate method of contraception

- Birth control should be used from the signing of the patient consent form and for 120
days following the last dose of study treatment.

- In addition, men must not donate sperm during study therapy and for 120 days after
receiving the last dose of study treatment.

Exclusion Criteria:

- 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

- 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

- 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

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

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

- Screening ECG abnormality documented by the investigator as medically significant

- Inability to comply with protocol or study procedures.

- Women who are pregnant or breastfeeding.