First in Patient Study for PF-06840003 in Malignant Gliomas

A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06840003 IN PATIENTS WITH MALIGNANT GLIOMAS

This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in patients with malignant gliomas.

Inclusion Criteria:

• Diagnosis of WHO Grade IV glioblastoma or WHO Grade III anaplastic gliomas
• For patients with Grade IV GBM, recurrent disease at the time of the first or second recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent disease at the time of at least a first recurrence but no more than a fourth recurrence or progression
• Karnofsky performance score greater than or equal to 70%
• Adequate bone marrow, kidney and liver function

Exclusion Criteria:

• History of CNS bleeding within 6 months of registration
• Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration
• Requires treatment with high dose systemic corticosteroids defined as >2 mg/day
• Radiation therapy within 12 weeks of registration