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
1 other identifier
interventional
83
1 country
8
Brief Summary
The purpose of this study is to assess the safety and tolerability of REGN421 (SAR153192) in patients with advanced solid malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2009
Longer than P75 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 26, 2014
March 1, 2014
4.7 years
March 25, 2009
March 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
18 months
Secondary Outcomes (1)
Preliminary evidence of antitumor activity
18 months
Study Arms (1)
Q2W
EXPERIMENTALREGN421 (SAR153192) taken once every two weeks (Q2W)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (8)
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2009
First Posted
March 30, 2009
Study Start
June 1, 2009
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 26, 2014
Record last verified: 2014-03