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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871559
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Malignancies Drug: REGN421(SAR153192) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Q2W
REGN421 (SAR153192) taken once every two weeks (Q2W)
Drug: REGN421(SAR153192)

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Preliminary evidence of antitumor activity [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00871559

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United States, Colorado
Aurora, Colorado, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00871559    
Other Study ID Numbers: R421-ST-0804
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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