An International, Multi-Center, Randomized, Double Blind Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of Lucanthone Administered as an Adjunct to Radiation and Temozolomide for Primary Therapy of Glioblastoma Multiforme

Main

Inclusion Criteria:

1. 18 and 70 years of age in India, 18 years and above in US

2. Histologically proven GBM who

- May or may not have undergone surgery

- Is scheduled to receive treatment with temozolomide and radiation.

3. Karnofsky score ≥ 70%.

Main Exclusion Criteria:

1. Diagnosis of recurrent brain tumor.

2. Received temozolomide previously.

3. Absolute neutrophil count ≤ 1.5 X 109/L.

4. Screening platelet count < 100 K/uL.

5. Screening bilirubin > 1.6 mg/dL.

6. Screening creatinine > 2.25 mg/dL in men and 1.8 mg/dL in women.

7. Screening ALT or AST > 2.5 times the upper limit of the laboratory reference range.

8. Unstable medical condition or significant comorbid pathophysiology (e.g. active
infection, poorly controlled diabetes, unstable angina, severe heart failure) that
would interfere with his/her participation in the study.

9. Enrolled, or plans to enroll, in a concurrent treatment protocol with another
investigational product.

10. Receiving, or plans to receive, an anti-cancer therapy other than temozolomide during
the study.

11. Received prior chemotherapy or radiation therapy within four weeks of enrollment.