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

March 25, 2009
March 24, 2014
June 2009
February 2014   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Safety, tolerability, and dose-limiting toxicities [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose and the recommended phase 2 dose [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00871559 on ClinicalTrials.gov Archive Site
Preliminary evidence of antitumor activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Preliminary evidence of antitumor activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics of REGN421 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Relationships between PK, toxicity and pharmacodynamic (PD) measures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Immunogenicity of REGN421 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Malignancies
Drug: REGN421(SAR153192)
Experimental: Q2W
REGN421 (SAR153192) taken once every two weeks (Q2W)
Intervention: Drug: REGN421(SAR153192)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00871559
R421-ST-0804
No
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP