A Multiple-Ascending-Dose Study of the Safety and Tolerability of REGN421(SAR153192) in Patients With Advanced Solid Malignancies

Inclusion criteria

• Male or female 18 years of age or older
• Histologically diagnosis of advanced solid malignancy, with no standard therapeutic options of proven benefit.
• Patients with measurable or non-measurable disease
• At least 6 weeks must have elapsed since the last dose of bevacizumab (AvastinTM)
• At least 4 weeks must have elapsed since the last major surgery
• For women of childbearing potential, a negative urine pregnancy test at the screening visit
• Willingness to use adequate contraception during the full course of the study. Systemic hormonal contraceptive agents are excluded
• Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
• Able to read, understand and willing to sign the informed consent form

Exclusion criteria

• Medical history of myocardial infarction or cardiomyopathy
• Unstable angina
• NYHA class II - IV congestive heart failure
• Patients under treatment with more than 2 antihypertensive medications
• History of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation, or clinically significant GI hemorrhage within 6 months of study drug administration
• Diabetic retinopathy
• Patients requiring anticoagulation
• Hypersensitivity to doxycycline or related compounds