Study of Nesvacumab (REGN910/ SAR307746)

Solid Tumors Clinical Trial

Official title:

A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271972
• Other study ID #: R910-ST-1010
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2011
• Last updated: June 12, 2015
• Start date: January 2011
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• nesvacumab (REGN910/ SAR307746)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies		28 days	Yes
Secondary	PK/PD profile		28 days	No
Secondary	Immunogenicity		28 days	Yes
Secondary	Anti-tumor activity		28 days	No
Secondary	Correlative biomarkers		28 days	No