Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)

Key facts

Study ID

NCT01688960

Run by

Regeneron Pharmaceuticals

People needed

48

Starts

2012-10-01

Expected to finish

2014-11-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria include, but are not limited to, the following:
• Confirmed diagnosis of solid tumor malignancy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate hepatic, renal and bone marrow function
• Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1

You may not qualify if…

• Exclusion criteria include, but are not limited to, the following:
• Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
• Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
• Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
• Patients with deep vein thrombosis or pulmonary embolism within last 3 months
• Patients with serious non healing wound or acute ulcer
• Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months
• Patients with history of abdominal or tracheal-esophageal fistula
• Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
• Prior treatment with bevacizumab within last 6 weeks
• Pregnant or breast-feeding women

Where it is running

• Study site — Indianapolis, Indiana, United States
• Study site — New York, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — San Antonio, Texas, United States
• Study site — Toronto, Canada

Full record on ClinicalTrials.gov

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