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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00871559
First received: March 25, 2009
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Advanced Solid Malignancies
Drug: REGN421(SAR153192)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary evidence of antitumor activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: June 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Q2W
REGN421 (SAR153192) taken once every two weeks (Q2W)
Drug: REGN421(SAR153192)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871559

Locations
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
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00871559     History of Changes
Other Study ID Numbers: R421-ST-0804
Study First Received: March 25, 2009
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 27, 2014