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Study of Nesvacumab (REGN910/ SAR307746)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271972
First Posted: January 7, 2011
Last Update Posted: June 16, 2015
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.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
January 5, 2011
January 7, 2011
June 16, 2015
January 2011
September 2014   (Final data collection date for primary outcome measure)
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies [ Time Frame: 28 days ]
Determine the maximum tolerable dose or recommended phase 2 dose of REGN910 in patients with advanced solid malignancies [ Time Frame: 28 days ]
Complete list of historical versions of study NCT01271972 on ClinicalTrials.gov Archive Site
  • PK/PD profile [ Time Frame: 28 days ]
  • Immunogenicity [ Time Frame: 28 days ]
  • Anti-tumor activity [ Time Frame: 28 days ]
  • Correlative biomarkers [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
 
Study of Nesvacumab (REGN910/ SAR307746)
A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
Drug: nesvacumab (REGN910/ SAR307746)
  • Experimental: Cohort 1
    Dose 1
    Intervention: Drug: nesvacumab (REGN910/ SAR307746)
  • Experimental: Cohort 2
    Dose 2
    Intervention: Drug: nesvacumab (REGN910/ SAR307746)
  • Experimental: Cohort 3
    Dose 3
    Intervention: Drug: nesvacumab (REGN910/ SAR307746)
  • Experimental: Cohort 4
    Dose 4
    Intervention: Drug: nesvacumab (REGN910/ SAR307746)
  • Experimental: Cohort 5
    Dose 5
    Intervention: Drug: nesvacumab (REGN910/ SAR307746)
  • Experimental: Expansion Cohort 1
    Dose 4
    Intervention: Drug: nesvacumab (REGN910/ SAR307746)
  • Experimental: Expansion Cohort 2
    Dose 5
    Intervention: Drug: nesvacumab (REGN910/ SAR307746)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
May 2015
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Confirmed diagnosis of advanced solid malignancy.
  2. ECOG performance status 0 - 1
  3. Adequate hepatic, renal and bone marrow function
  4. At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
  5. At least 6 weeks since last dose of bevacizumab
  6. At least 4 weeks since last surgery
  7. At least 4 weeks since last dose of investigational treatment

Exclusion Criteria:

  1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
  2. Patients with serious non healing wound or acute ulcer
  3. Either systolic blood pressure >150 mm Hg or diastolic blood pressure >95 mm Hg
  4. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
  5. Patients with deep vein thrombosis or pulmonary embolism within last 6 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01271972
R910-ST-1010
Yes
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
June 2015

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