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

Recruiting now · Phase 2

Conditions studied: Neoplasms, Child, Adolescent

In brief

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.

Key facts

Study ID

NCT05999994

Run by

Eli Lilly and Company

People needed

105

Starts

2020-01-22

Expected to finish

2027-05-01

Last updated by the study team

2026-08-07

Who can join

Age: 1 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Universitaetsklinikum Freiburg — Freiburg im Breisgau, Germany (enrolling)
• Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo, Italy (enrolling)
• Seattle Children's Hospital Research Foundation — Seattle, Washington, United States (enrolling)
• Universitaetsklinikum Essen — Essen, Germany (enrolling)
• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (enrolling)
• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• UCL- Saint Luc — Brussels, Belgium (enrolling)
• Centre Leon Berard — Lyon, France (enrolling)
• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Children's Hospital of Orange County — Orange, California, United States (enrolling)
• Children's Hospital of Colorado — Denver, Colorado, United States (enrolling)
• Universitaetsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Nationwide Children's Hosp — Columbus, Ohio, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux, France (enrolling)
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Lifespan Cancer Institute — Providence, Rhode Island, United States (enrolling)
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States (enrolling)
• Istituto Nazionale dei Tumori — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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