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
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) Vinorelbine 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 + Gemcitabine + Docetaxel (SS ISA) Ramucirumab Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. Cyclophosphamide + Vinorelbine (DSRCT ISA) Cyclophosphamide Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA. Abemaciclib + Irinotecan + Temozolomide (ES ISA) Irinotecan Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA) Cyclophosphamide 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 + Cyclophosphamide + Vinorelbine (DSRCT ISA) Ramucirumab 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). Cyclophosphamide + Vinorelbine (DSRCT ISA) Vinorelbine Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA. Gemcitabine + Docetaxel (SS ISA) Docetaxel Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA. Ramucirumab + Gemcitabine + Docetaxel (SS ISA) Gemcitabine Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. Ramucirumab + Gemcitabine + Docetaxel (SS ISA) Docetaxel Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA. Gemcitabine + Docetaxel (SS ISA) Gemcitabine Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA. Abemaciclib + Irinotecan + Temozolomide (ES ISA) Abemaciclib Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. Abemaciclib + Irinotecan + Temozolomide (ES ISA) Temozolomide Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA. Irinotecan + Temozolomide (ES ISA) Irinotecan Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA. Irinotecan + Temozolomide (ES ISA) Temozolomide Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
- Primary Outcome Measures
Name Time Method Number of Participants Allocated to Each ISA Baseline up to Week 4 Number of Participants Allocated to Each ISA
- Secondary Outcome Measures
Name Time Method
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