CompletedPhase 1

A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors

United States29 participantsStarted 2015-12-11

Plain-language summary

The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.

Who can participate

Age range

12 Months – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Part A: participants with recurrent or refractory non-CNS solid tumors * Part B: participants with recurrent or refractory CNS tumors * Measurable or evaluable disease * No other therapeutic options * Performance Status: Karnofsky ≥50% for participants \>16 years and Lansky ≥50 for participants ≤16 years Exclusion Criteria: * Active or recent history of serious bleeding events * Active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses * Active or recent history of hypertensive crisis or hypertensive encephalopathy * Active non-healing wound or bone fracture * History of solid organ transplant

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab

Timeframe: Baseline to Study Completion (Up to 42 Months)

Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Timeframe: Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)

Number of Participants With Anti-Ramucirumab Antibodies

Timeframe: Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)

Trial details

NCT IDNCT02564198

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-16

Results submitted2021-06-14

View on ClinicalTrials.gov More Pediatric Solid Tumor trials