- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01688960
Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies
March 16, 2015 updated by: Regeneron Pharmaceuticals
A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Toronto, Canada
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Indiana
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Indianapolis, Indiana, United States
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New York
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New York, New York, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Texas
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San Antonio, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion criteria include, but are not limited to, the following:
- Confirmed diagnosis of solid tumor malignancy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hepatic, renal and bone marrow function
- Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1
Exclusion Criteria:
Exclusion criteria include, but are not limited to, the following:
- Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
- Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- Patients with deep vein thrombosis or pulmonary embolism within last 3 months
- Patients with serious non healing wound or acute ulcer
- Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months
- Patients with history of abdominal or tracheal-esophageal fistula
- Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
- Prior treatment with bevacizumab within last 6 weeks
- Pregnant or breast-feeding women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort 1
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Dose level 1
Dose level 2
Dose level 3
Dose level 1
Other Names:
Dose level 2
Other Names:
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Experimental: Cohort 2
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Dose level 1
Dose level 2
Dose level 3
Dose level 1
Other Names:
Dose level 2
Other Names:
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Experimental: Cohort 4
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Dose level 1
Dose level 2
Dose level 3
Dose level 1
Other Names:
Dose level 2
Other Names:
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Experimental: Cohort 3a
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Dose level 1
Dose level 2
Dose level 3
Dose level 1
Other Names:
Dose level 2
Other Names:
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Experimental: Cohort 3b
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Dose level 1
Dose level 2
Dose level 3
Dose level 1
Other Names:
Dose level 2
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)
Time Frame: Day 1 to Day 28
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Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies
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Day 1 to Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK)
Time Frame: Day 1 to Day 170
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To assess PK parameters such as concentration of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept).
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Day 1 to Day 170
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Immunogenicity
Time Frame: Day 1 to Day 170
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To assess the anti-drug antibodies of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept)
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Day 1 to Day 170
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Antitumor activity
Time Frame: Day 1 to Day 170
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Objective tumor response according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1
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Day 1 to Day 170
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Pharmacodynamics (PD)
Time Frame: Day 1 to Day 170
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Target inhibition biomarker changes, serum tumor markers
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Day 1 to Day 170
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 17, 2012
First Submitted That Met QC Criteria
September 17, 2012
First Posted (Estimate)
September 20, 2012
Study Record Updates
Last Update Posted (Estimate)
March 17, 2015
Last Update Submitted That Met QC Criteria
March 16, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R910-ST-1114
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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