A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
A Phase 1 Study Of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children With Refractory Solid Tumors, Including CNS Tumors
3 other identifiers
interventional
29
1 country
21
Brief Summary
The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2015
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedStudy Start
First participant enrolled
December 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2019
CompletedResults Posted
Study results publicly available
August 17, 2021
CompletedAugust 17, 2021
July 1, 2021
3.6 years
September 25, 2015
June 14, 2021
July 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab
A DLT is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0: 1\. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT. 8\. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
Baseline to Study Completion (Up to 42 Months)
Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab.
Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)
Number of Participants With Anti-Ramucirumab Antibodies
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.
Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)
Secondary Outcomes (4)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Baseline to Date of Objective Disease Progression (Up to 42 Months)
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
Baseline to Date of Objective Disease Progression (Up to 42 Months)
Duration of Response (DOR)
Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 42 Months)
Overall Survival
Baseline to Date of Death from Any Cause (Up to 42 Months)
Study Arms (1)
Ramucirumab
EXPERIMENTAL(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.
Interventions
Eligibility Criteria
You may qualify if:
- Part A: participants with recurrent or refractory non-CNS solid tumors
- 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
You may not qualify if:
- Active or recent history of serious bleeding events
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Children's Oncology Groupcollaborator
Study Sites (21)
Childrens Hospital of Alabama
Birmingham, Alabama, 35233, United States
Children's Oncology Group
Monrovia, California, 91016, United States
Childrens Hospital of Orange County
Orange, California, 92868, United States
University of California, San Francisco
San Francisco, California, 94158, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30322, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Mark O Harfield-Warren Grant Magnuson Clinical Center
Bethesda, Maryland, 20892, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
University of Minnesota Hospital
Minneapolis, Minnesota, 55455, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105, United States
Texas Childrens Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2015
First Posted
September 30, 2015
Study Start
December 11, 2015
Primary Completion
July 16, 2019
Study Completion
July 16, 2019
Last Updated
August 17, 2021
Results First Posted
August 17, 2021
Record last verified: 2021-07