Study of Nesvacumab (REGN910/ SAR307746)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01271972
First received: January 5, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.


Condition Intervention Phase
Solid Tumors
Drug: nesvacumab (REGN910/ SAR307746)
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 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: January 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose 1
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 2
Dose 2
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 3
Dose 3
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 4
Dose 4
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Cohort 5
Dose 5
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Expansion Cohort 1
Dose 4
Drug: nesvacumab (REGN910/ SAR307746)
Experimental: Expansion Cohort 2
Dose 5
Drug: nesvacumab (REGN910/ SAR307746)

  Eligibility

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

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
  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: NCT01271972

Locations
United States, California
San Francisco, California, United States
United States, Texas
San Antonio, Texas, United States
Canada, Ontario
Toronto, Ontario, Canada
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: NCT01271972     History of Changes
Other Study ID Numbers: R910-ST-1010
Study First Received: January 5, 2011
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

ClinicalTrials.gov processed this record on July 22, 2014