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

A Phase 1, Multiple-Dose Study of the Safety and Tolerability of Single Agent REGN421 Administered Every 2 or 3 Weeks in Patients With Advanced Solid Malignancies

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Malignancies
• Intervention / Treatment: Drug: REGN421(SAR153192)

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Michigan
    • Detroit, Michigan, United States
  • Missouri
    • St. Louis, Missouri, United States
  • New York
    • New York, New York, United States
  • Ohio
    • Columbus, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Q2W; REGN421 (SAR153192) taken once every two weeks (Q2W)	Drug: REGN421(SAR153192)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Preliminary evidence of antitumor activity	18 months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 25, 2009
• First Submitted That Met QC Criteria: March 27, 2009
• First Posted (Estimate): March 30, 2009

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: R421-ST-0804