A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
NCT ID: NCT02564198
Last Updated: 2021-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2015-12-11
2019-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ramucirumab
(Part A-Non-CNS Solid Tumors) Escalating doses of 8 milligrams per kilogram (mg/kg) or 12 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle.
(Part B-CNS Tumors) Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
Ramucirumab
Administered IV
Interventions
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Ramucirumab
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part B: participants with recurrent or refractory CNS tumors
* Measurable or evaluable disease
* No other therapeutic options
* Performance Status: Karnofsky ≥50% for participants \>16 years and Lansky ≥50 for participants ≤16 years
Exclusion Criteria
* Active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses
* Active or recent history of hypertensive crisis or hypertensive encephalopathy
* Active non-healing wound or bone fracture
* History of solid organ transplant
12 Months
21 Years
ALL
No
Sponsors
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Children's Oncology Group
NETWORK
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Childrens Hospital of Alabama
Birmingham, Alabama, United States
Children's Oncology Group
Monrovia, California, United States
Childrens Hospital of Orange County
Orange, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Mark O Harfield-Warren Grant Magnuson Clinical Center
Bethesda, Maryland, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
University of Minnesota Hospital
Minneapolis, Minnesota, United States
Washington University Medical School
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
St Jude Childrens Research Hospital
Memphis, Tennessee, United States
Texas Childrens Hospital
Houston, Texas, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
Other Identifiers
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I4T-MC-JVDA
Identifier Type: OTHER
Identifier Source: secondary_id
ADVL1416
Identifier Type: OTHER
Identifier Source: secondary_id
15542
Identifier Type: -
Identifier Source: org_study_id
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