No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 – 39
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for children and young adults with cancer to participate in various studies testing new drugs. Participants will help researchers find out how well these drugs work and will need to meet specific health requirements.
Are You a Good Fit for This Trial?
You may be able to join if
I have a type of cancer that can be measured or evaluated.
I am under 16 years old and have a Lansky performance score of at least 50 or am 16 years old or older with a Karnofsky performance score of at least 50.
I have stopped all cancer treatments for at least 7 days and have recovered from side effects.
I have adequate blood and organ function.
If I am a girl who can get pregnant, I have had a negative pregnancy test within 7 days before starting the trial.
If I can get pregnant, I will use effective birth control during the trial and for 3 months after.
You may not be able to join if
I have a severe or uncontrolled medical condition or mental health issue that could cause safety risks.
I have an active infection that needs treatment.
I have had a bone marrow or solid organ transplant.
I am planning to have certain invasive medical procedures.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 dep…
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.
Trial Locations
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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 …
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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