A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
NCT ID: NCT05999994
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
105 participants
INTERVENTIONAL
2020-01-22
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
Ramucirumab
Administered IV
Cyclophosphamide
Administered orally
Vinorelbine
Administered IV
Cyclophosphamide + Vinorelbine (DSRCT ISA)
Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
Cyclophosphamide
Administered orally
Vinorelbine
Administered IV
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Ramucirumab
Administered IV
Gemcitabine
Administered IV
Docetaxel
Administered IV
Gemcitabine + Docetaxel (SS ISA)
Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
Gemcitabine
Administered IV
Docetaxel
Administered IV
Abemaciclib + Irinotecan + Temozolomide (ES ISA)
Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Abemaciclib
Administered orally
Irinotecan
Administered IV
Temozolomide
Administered orally
Irinotecan + Temozolomide (ES ISA)
Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
Irinotecan
Administered IV
Temozolomide
Administered orally
Interventions
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Ramucirumab
Administered IV
Cyclophosphamide
Administered orally
Vinorelbine
Administered IV
Gemcitabine
Administered IV
Docetaxel
Administered IV
Abemaciclib
Administered orally
Irinotecan
Administered IV
Temozolomide
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
1 Year
39 Years
ALL
No
Sponsors
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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 8 AM - 8 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
Phoenix Children's Hospital
Phoenix, Arizona, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Childrens Hospital of Los Angeles
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Children's Hospital of Colorado
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Children's Healthcare of Atlanta, Inc. at Egleston
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
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
University of Minnesota Hospital
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University Medical School
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Nationwide Children's Hosp
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Cook Children's Hospital
Fort Worth, Texas, United States
Texas Childrens Hospital
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Chris O'Brien Lifehouse
Camperdown, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Royal Children's Hospital
Melbourne, , Australia
The Sydney Children's Hospitals Network
Westmead, , Australia
UCL- Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, , France
Centre Leon Berard
Lyon, , France
Centre Leon Berard
Lyon, , France
Institut Curie
Paris, , France
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
IRCCS Istituto Ortopedico Rizzoli
Bologna, , Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, , Italy
Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliera Di Padova
Padua, , Italy
Ospedale Bambino Gesu
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
National Cancer Center Hospital
Chūōku, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Hyogo Prefectural Kobe Children's Hospital
Kobe, , Japan
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Prinses Maxima Centrum
Utrecht, , Netherlands
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
University College Hospital - London
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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J1S-MC-JAAA
Identifier Type: OTHER
Identifier Source: secondary_id
17304
Identifier Type: -
Identifier Source: org_study_id
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