Study of Nesvacumab (REGN910/ SAR307746)

This study is currently recruiting participants.
Verified September 2013 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01271972
First received: January 5, 2011
Last updated: September 13, 2013
Last verified: September 2013

January 5, 2011
September 13, 2013
January 2011
July 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 ] [ Designated as safety issue: Yes ]
Determine the maximum tolerable dose or recommended phase 2 dose of REGN910 in patients with advanced solid malignancies [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01271972 on ClinicalTrials.gov Archive Site
  • PK/PD profile [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Anti-tumor activity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Correlative biomarkers [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
72
July 2014
July 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
Both
18 Years and older
No
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com
United States,   Canada
 
NCT01271972
R910-ST-1010
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
September 2013

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