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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Months - 21 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02564198
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pediatric Solid Tumor, Refractory Tumor, Recurrent Tumor, CNS Malignancies
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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.

Interventions

Drug: - Ramucirumab

Administered IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Childrens Hospital of Alabama, Birmingham, Alabama

Status

Address

Childrens Hospital of Alabama

Birmingham, Alabama, 35233

Children's Oncology Group, Monrovia, California

Status

Address

Children's Oncology Group

Monrovia, California, 91016

Childrens Hospital of Orange County, Orange, California

Status

Address

Childrens Hospital of Orange County

Orange, California, 92868

University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94158

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010-2970

Atlanta, Georgia

Status

Address

Children's Healthcare of Atlanta at Scottish Rite

Atlanta, Georgia, 30322

Chicago, Illinois

Status

Address

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

Riley Hospital for Children, Indianapolis, Indiana

Status

Address

Riley Hospital for Children

Indianapolis, Indiana, 46202

Bethesda, Maryland

Status

Address

Mark O Harfield-Warren Grant Magnuson Clinical Center

Bethesda, Maryland, 20892

University of Michigan Health Systems, Ann Arbor, Michigan

Status

Address

University of Michigan Health Systems

Ann Arbor, Michigan, 48109

University of Minnesota Hospital, Minneapolis, Minnesota

Status

Address

University of Minnesota Hospital

Minneapolis, Minnesota, 55455

Washington University Medical School, Saint Louis, Missouri

Status

Address

Washington University Medical School

Saint Louis, Missouri, 63110

Columbia University Medical Center, New York, New York

Status

Address

Columbia University Medical Center

New York, New York, 10032

Children's Hospital Medical Center, Cincinnati, Ohio

Status

Address

Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039

Oregon Health and Science University, Portland, Oregon

Status

Address

Oregon Health and Science University

Portland, Oregon, 97239

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Childrens Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Address

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

St Jude Childrens Research Hospital, Memphis, Tennessee

Status

Address

St Jude Childrens Research Hospital

Memphis, Tennessee, 38105

Texas Childrens Hospital, Houston, Texas

Status

Address

Texas Childrens Hospital

Houston, Texas, 77030

Seattle, Washington

Status

Address

Seattle Children's Hospital Research Foundation

Seattle, Washington, 98105

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226