A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Study Of Cvx-241, A Selective Angiopoietin-2 And Vascular Endothelial Growth Factor Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors

The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.

The study was prematurely discontinued on 14 September 2011 due to no significant pharmacological effects (safety/PD/efficacy) through 25 mg/kg cohort, the T1/2 based on VEGF binding was shorter than expected and the current and/or higher doses were not considered feasible for further development. There were no safety concerns associated with the decision to terminate the program/study.

Inclusion Criteria:

• Confirmed solid tumors unresponsive to current therapy or for which there is no standard therapy.
• Stage 2 only: Histologically or cytologically documented EOC or PPC with < or equal to 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.
• Adequate coagulation, liver, and renal function.
• Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging [DCE-MRI] evaluation
• Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

Exclusion Criteria:

• History of clinically significant toxicity to Vascular Endothelial Growth Factor [VEGF] inhibition.
• Evidence of bleeding problems.
• Uncontrolled hypertension.
• Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell histology