Status:
RECRUITING
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Neoplasms
Child
Eligibility:
All Genders
1-39 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05999994
Start Date
January 22 2020
End Date
May 1 2027
Last Update
December 12 2025
Active Locations (74)
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1
Childrens Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
4
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027