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

Launched by ELI LILLY AND COMPANY · Aug 14, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on testing new cancer drugs specifically designed for children and young adults. It is part of a larger research effort that allows multiple studies to be conducted under one main protocol. This means that as new treatments become available, they can be tested more efficiently, helping us find better options for young patients battling cancer. Participants in this trial will be monitored to see how well these new drugs work and how long their benefits last.

To join the trial, participants must be between the ages of 1 and 19 years, have measurable cancer that can be evaluated, and have stopped any previous cancer treatments for at least a week. They also need to have good overall health and agree to certain safety measures, especially if they are capable of becoming pregnant. If eligible, participants will receive the new treatment and regular check-ups to assess their progress. It's important to note that individuals with serious health issues, active infections, or those who are pregnant or breastfeeding cannot participate. This trial aims to provide hope for improved treatments for young cancer patients.

Gender

ALL

Eligibility criteria

• 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.