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

Registration Number
NCT05999994
Lead Sponsor
Eli Lilly and Company
Brief 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 canc...

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
105
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.
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)VinorelbineRamucirumab 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 + Gemcitabine + Docetaxel (SS ISA)RamucirumabRamucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Cyclophosphamide + Vinorelbine (DSRCT ISA)CyclophosphamideCyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
Abemaciclib + Irinotecan + Temozolomide (ES ISA)IrinotecanAbemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)CyclophosphamideRamucirumab 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 + Cyclophosphamide + Vinorelbine (DSRCT ISA)RamucirumabRamucirumab 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).
Cyclophosphamide + Vinorelbine (DSRCT ISA)VinorelbineCyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
Gemcitabine + Docetaxel (SS ISA)DocetaxelGemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)GemcitabineRamucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Ramucirumab + Gemcitabine + Docetaxel (SS ISA)DocetaxelRamucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Gemcitabine + Docetaxel (SS ISA)GemcitabineGemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
Abemaciclib + Irinotecan + Temozolomide (ES ISA)AbemaciclibAbemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Abemaciclib + Irinotecan + Temozolomide (ES ISA)TemozolomideAbemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Irinotecan + Temozolomide (ES ISA)IrinotecanIrinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
Irinotecan + Temozolomide (ES ISA)TemozolomideIrinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
Primary Outcome Measures
NameTimeMethod
Number of Participants Allocated to Each ISABaseline up to Week 4

Number of Participants Allocated to Each ISA

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (66)

UCL- Saint Luc

🇧🇪

Bruxelles, Belgium

Institut Curie

🇫🇷

Paris, France

Prinses Maxima Centrum

🇳🇱

Utrecht, Netherlands

Childrens Hospital of Alabama

🇺🇸

Birmingham, Alabama, United States

Phoenix Children's Hospital

🇺🇸

Phoenix, Arizona, United States

Childrens Hospital of Los Angeles

🇺🇸

Los Angeles, California, United States

National Cancer Center Hospital

🇯🇵

Chuo-ku, Tokyo, Japan

Kyushu University Hospital

🇯🇵

Fukuoka, Japan

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

Hospital Universitari Vall d'Hebron

🇪🇸

Barcelona, Barcelona [Barcelona], Spain

Leids Universitair Medisch Centrum

🇳🇱

Leiden, Zuid-Holland, Netherlands

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, 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

🇺🇸

Saint 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

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, New South Wales, Australia

The Sydney Children's Hospitals Network

🇦🇺

Westmead, New South Wales, Australia

Peter MacCallum Cancer Centre

🇦🇺

Melbourne, Victoria, Australia

Royal Children's Hospital

🇦🇺

Melbourne, Victoria, Australia

Universitair Ziekenhuis Gent

🇧🇪

Gent, Oost-Vlaanderen, Belgium

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

🇫🇷

Bordeaux, Aquitaine, France

Centre Leon Berard

🇫🇷

Lyon, Rhône-Alpes, France

Universitaetsklinikum Freiburg

🇩🇪

Freiburg, Baden-Württemberg, Germany

Universitaetsklinikum Essen

🇩🇪

Essen, Germany

Universitaetsklinikum Hamburg-Eppendorf

🇩🇪

Hamburg, Germany

Istituto Nazionale dei Tumori

🇮🇹

Milano, Lombardie, Italy

Istituto Clinico Humanitas

🇮🇹

Rozzano, Milano, Italy

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

🇮🇹

Candiolo, Torino, Italy

Hyogo Prefectural Kobe Children's Hospital

🇯🇵

Kobe, Hyogo, Japan

Azienda Ospedaliera Di Padova

🇮🇹

Padova, Veneto, Italy

IRCCS Istituto Ortopedico Rizzoli

🇮🇹

Bologna, Italy

Ospedale Bambino Gesu

🇮🇹

Roma, Italy

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

🇮🇹

Roma, Italy

Hospital Sant Joan de Déu

🇪🇸

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Hospital Infantil Universitario Niño Jesús

🇪🇸

Madrid, Madrid, Comunidad De, Spain

Hospital Universitario de Canarias

🇪🇸

La Laguna, Santa Cruz De Tenerife, Spain

Hospital de la Santa Creu i Sant Pau

🇪🇸

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

🇪🇸

Madrid, Spain

Hospital Universitario La Paz

🇪🇸

Madrid, Spain

Hospital Universitario Virgen Del Rocio

🇪🇸

Sevilla, Spain

Hospital Universitari i Politecnic La Fe

🇪🇸

València, Spain

University College Hospital - London

🇬🇧

London, Greater 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

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