A master protocol for testing cancer drugs in children and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This master protocol aims to streamline the execution of multiple clinical trials for children and young adults with cancer by providing a unified research framework. It allows for the testing of various drugs, including Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, and Docetaxel, under specific research goals tailored to different cancer types. New studies can be incorporated as new treatments become available, enhancing the efficiency of cancer research. Participants will be enrolled based on their eligibility and the duration of benefit from the treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• Children's Hospital of Colorado
  Denver, Colorado, United States Recruiting
• Children's National Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Golisano Children's Hospital of Southwest Florida
  Fort Myers, Florida, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.