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NCT05999994PHASE2Recruiting

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Eli Lilly and Company

Start Date

1/22/2020

Completion Date

5/1/2027

Summary

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Eligibility Criteria

Age Range: 1 years to 39 years

Inclusion Criteria: Participants must meet all of the inclusion criteria below. Additional criteria are specified in the protocol amendment (individual addenda) to which the participant will enroll. * Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). * The participant has a Lansky (\<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50. * Participants must have discontinued all previous treatments for cancer or investigational agents greater than or equal to (≥)7 days after the last dose and must have recovered from clinically significant side effects. * The participant has adequate hematologic and organ function. * Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to first dose. * Both female and male participants of childbearing potential must agree to use highly effective contraceptive precautions during the trial and for at least 3 months following the last dose of study drug. Participants will be ineligible if they meet any of the exclusion criteria below. Additional criteria are specified in the protocol amendment to which the participant will enroll. * Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that, in the opinion of the investigator, could cause unacceptable safety risks or compromise compliance with the protocol. * Participants who have active infections requiring therapy. * Participants who have had allogeneic bone marrow or solid organ transplant. * Participants who have had, or are planning to have, certain invasive procedures. * Female participants who are pregnant or breastfeeding.

Interventions

DRUG

Ramucirumab

DRUG

Cyclophosphamide

DRUG

Vinorelbine

DRUG

Gemcitabine

DRUG

Docetaxel

DRUG

Abemaciclib

DRUG

Irinotecan

DRUG

Temozolomide

Interested in This Trial?

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Conditions

NeoplasmsChildAdolescent

Locations

Childrens Hospital of Alabama

Birmingham, Alabama 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Childrens Hospital of Los Angeles

Los Angeles, California 90027

United States

UCLA Medical Center

Los Angeles, California 90095

United States

Children's Hospital of Orange County

Orange, California 92868

United States

Children's Hospital of Colorado

Denver, Colorado 80218

United States

Children's National Medical Center

Washington D.C., District of Columbia 20010

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida 33908

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224

United States

Children's Healthcare of Atlanta, Inc. at Egleston

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 46202-5225

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

University of Minnesota Hospital

Minneapolis, Minnesota 55455

United States

Children's Mercy Hospital

Kansas City, Missouri 64108

United States

Washington University Medical School

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Nationwide Children's Hosp

Columbus, Ohio 43205-2664

United States

Oregon Health and Science University

Portland, Oregon 97201

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

Lifespan Cancer Institute

Providence, Rhode Island 02906

United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas 75390-9063

United States

Cook Children's Hospital

Fort Worth, Texas 76104-2724

United States

Texas Childrens Hospital

Houston, Texas 77025

United States

University of Texas MD Anderson Cancer Center

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

Chris O'Brien Lifehouse

Camperdown, 2050

Australia

Peter MacCallum Cancer Centre

Melbourne, 3000

Australia

Royal Children's Hospital

Melbourne, 3052

Australia

The Sydney Children's Hospitals Network

Westmead, 2145

Australia

UCL- Saint Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, 33076

France

Centre Leon Berard

Lyon, 69008

France

Centre Leon Berard

Lyon, 69008

France

Institut Curie

Paris, 75248

France

Universitaetsklinikum Essen

Essen, 45147

Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20251

Germany

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136

Italy

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

Candiolo, 10060

Italy

Istituto Nazionale dei Tumori

Milan, 20133

Italy

Azienda Ospedaliera Di Padova

Padova, 35128

Italy

Ospedale Bambino Gesu

Roma, 00165

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

National Cancer Center Hospital

Chūōku, 104-0045

Japan

Kyushu University Hospital

Fukuoka, 812-8582

Japan

Hyogo Prefectural Kobe Children's Hospital

Kobe, 650-0047

Japan

Leids Universitair Medisch Centrum

Leiden, 2333 ZA

Netherlands

Prinses Maxima Centrum

Utrecht, 3584 CS

Netherlands

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 8035

Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, 8950

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Infantil Universitario Niño Jesús

Madrid, 28009

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

University College Hospital - London

London, NW1 2PG

United Kingdom

Royal Marsden Hospital

London, SW3 6JJ

United Kingdom

Royal Marsden Hospital

London, SW3 6JJ

United Kingdom

Royal Manchester Children's Hospital

Manchester, M13 9WL

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom