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A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors

This study is currently recruiting participants.
Verified May 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02564198
First Posted: September 30, 2015
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Pediatric Solid Tumor Refractory Tumor Recurrent Tumor CNS Malignancies Drug: Ramucirumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Maximum Tolerated Dose of Ramucirumab [ Time Frame: Baseline to Study Completion (Approximately 42 Months) ]
  • Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 6 Months) ]
  • Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 42 Months) ]

Secondary Outcome Measures:
  • Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD): Best Overall Response (BOR) [ Time Frame: Baseline to Date of Objective Disease Progression (Approximately 42 Months) ]

Estimated Enrollment: 36
Study Start Date: December 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab

(Part A-Non-CNS Solid Tumors) Escalating doses of ramucirumab given intravenously (IV) every other week over a 6-week cycle. Participants may continue treatment until discontinuation criteria are met.

(Part B-CNS Tumors) Maximum tolerated dose and/or recommended Phase 2 Dose (RP2D) determined from Part A of ramucirumab given IV every other week over a 6-week cycle. Participants may continue treatment until discontinuation criteria are met.

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564198


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
Locations
United States, Alabama
Childrens Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact    205-638-9285      
Principal Investigator: Alyssa Reddy         
United States, California
SMO Children's Oncology Group Recruiting
Monrovia, California, United States, 91016
Contact    626-241-1630      
Principal Investigator: Children's Oncology Group         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact    714-532-8629      
Principal Investigator: Ivan Kirov         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact    415-476-3831      
Principal Investigator: Katherine Matthay         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact    202-476-4744      
Principal Investigator: AeRang Kim         
United States, Georgia
Children's Healthcare of Atlanta at Scottish Rite Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-727-1180      
Principal Investigator: Cynthia Wetmore         
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact    312-227-4844      
Principal Investigator: Stewart Goldman         
United States, Indiana
Riley Hosptial for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-944-8784      
Principal Investigator: James Croop         
United States, Maryland
Mark O Harfield-Warren Grant Magnuson Clinical Center Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact    301-496-7387      
Principal Investigator: Brigitte Widemann         
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109
Contact    734-764-7126      
Principal Investigator: Rajen Mody         
United States, Minnesota
University of Minnesota Hospital Recruiting
Minneapolis, Minnesota, United States, 55455
Contact    612-626-2378      
Principal Investigator: Emily Greengard         
United States, Missouri
Washington University Medical Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact    314-362-7229      
Principal Investigator: Robert Hayashi         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    212-305-5808      
Principal Investigator: Julia Bender         
United States, Ohio
Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact    513-636-6090      
Principal Investigator: James Geller         
United States, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact    503-494-1543      
Principal Investigator: Suman Malempati         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    267-425-3010      
Principal Investigator: Elizabeth Fox         
Childrens Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact    412-692-5055      
Principal Investigator: Jean Tersak         
United States, Tennessee
St Jude Childrens Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact    901-595-2403      
Principal Investigator: Wayne Furman         
United States, Texas
Texas Childrens Hospital Recruiting
Houston, Texas, United States, 77030
Contact    832-824-4632      
Principal Investigator: Jodi Muscal         
United States, Washington
Seattle Children's Hospital Research Foundation Recruiting
Seattle, Washington, United States, 98105
Contact    206-907-2106      
Principal Investigator: Julie Park         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact    414-456-8131      
Principal Investigator: Paul Harker-Murray         
Sponsors and Collaborators
Eli Lilly and Company
Children's Oncology Group
Investigators
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
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02564198     History of Changes
Other Study ID Numbers: 15542
I4T-MC-JVDA ( Other Identifier: Eli Lilly and Company )
ADVL1416 ( Other Identifier: Children's Oncology Group )
First Submitted: September 25, 2015
First Posted: September 30, 2015
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eli Lilly and Company:
relapsed pediatric solid tumors
unspecified childhood solid tumor
brain and central nervous system tumors

Additional relevant MeSH terms:
Neoplasms
Endothelial Growth Factors
Ramucirumab
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents