Status:
COMPLETED
A Multiple-Ascending-Dose Study of the Safety and Tolerability of REGN421(SAR153192) in Patients With Advanced Solid Malignancies
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00871559
Start Date
June 1 2009
End Date
February 1 2014
Last Update
March 26 2014
Active Locations (8)
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1
Aurora, Colorado, United States
2
Indianapolis, Indiana, United States
3
Boston, Massachusetts, United States
4
Detroit, Michigan, United States