A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research
Eli Lilly and Company
105 participants
Jan 22, 2020
INTERVENTIONAL
Conditions
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 cancers. Participation in the trial will depend on how long the benefit lasts.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Administered IV
Administered orally
Administered IV
Administered IV
Administered IV
Administered orally
Administered IV
Administered orally
Locations(73)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05999994