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

Phase 1

Completed

• Conditions: Advanced Solid Malignancies
• Interventions: Drug: REGN421(SAR153192)

• Registration Number: NCT00871559
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Start: 2009-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Q2W	REGN421(SAR153192)	REGN421 (SAR153192) taken once every two weeks (Q2W)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	18 months

Secondary Outcome Measures

Name	Time	Method
Preliminary evidence of antitumor activity	18 months