Master Protocol for Cancer Drugs in Children and Young Adults

This study is a master protocol, which means it's a framework for several clinical trials testing different drugs for children and young adults with cancer. The drugs being tested include ramucirumab, cyclophosphamide, vinorelbine, gemcitabine, and docetaxel. You might be able to join if you are between 1 and 39 years old and have cancer that can be measured or evaluated using standard techniques (RECIST 1.1). The main goal of this master protocol is to see how many participants are assigned to each specific study within the larger framework. The current recruitment status is unclear, but new studies will be added as new drugs become available.

Study design
This is an interventional study with a planned enrollment of 105 participants. It serves as a common protocol for multiple individual clinical trials.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from baseline up to Week 4, but the overall follow-up duration is not specified.

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NCT05999994

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

Recruiting
PHASE2Ages 1–39InterventionalTreatment
Eli Lilly and Company
~105 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:RamucirumabCyclophosphamideVinorelbineGemcitabineDocetaxelAbemaciclib

At a glance

Recruiting sites
52 of 72 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Allocated to Each ISA
Measured over Baseline up to Week 4
Neoplasms
Child
Adolescent
72 sites across 30 states
Spain13
Italy7
United Kingdom5
Texas4
France4
California3
Australia3
Germany3
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Eligibility criteria

Inclusion

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

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.
  • Number of Participants Allocated to Each ISABaseline up to Week 4

    Number of Participants Allocated to Each ISA