Study of Nesvacumab (REGN910/ SAR307746)

NCT ID: NCT01271972

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Dose 1

Group Type EXPERIMENTAL

nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Cohort 2

Dose 2

Group Type EXPERIMENTAL

nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Cohort 3

Dose 3

Group Type EXPERIMENTAL

nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Cohort 4

Dose 4

Group Type EXPERIMENTAL

nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Cohort 5

Dose 5

Group Type EXPERIMENTAL

nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Expansion Cohort 1

Dose 4

Group Type EXPERIMENTAL

nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Expansion Cohort 2

Dose 5

Group Type EXPERIMENTAL

nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Interventions

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nesvacumab (REGN910/ SAR307746)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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San Francisco, California, United States

Site Status

San Antonio, Texas, United States

Site Status

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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R910-ST-1010

Identifier Type: -

Identifier Source: org_study_id

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