A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children a… (NCT04238819) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
United States, Australia, Belgium47 participantsStarted 2020-11-09
Plain-language summary
The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years.
Who can participate
Age range
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:
* Parts A and B only:
* Participants must be less than or equal to (≤)18 years of age.
* Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5
* Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies.
* For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS.
* Part C only:
* Participants must be less than (\<) 21 years of age.
* Participants have a BSA ≥0.2 m².
* Participants with first relapse/refractory neuroblastoma.
* All Parts
* Participants must have measurable or evaluable disease by RECIST v1.1 or RANO.
* A Lansky score ≥50 for participants \<16 years of age or Karnofsky score ≥50 for participants ≥16 years of age.
* Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment.
* Able to swallow and/or have a gastric/nasogastric tube.
* Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug.
* Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment).
* Female participants of reproductive potential must agree to use hig…
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
1
Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)
Timeframe: Cycles 1 and 2 (21 Day Cycles)
2
Number or Participants With Dose Limiting Toxicities (DLTs) in Part A
Timeframe: Cycle 1 (21 Day Cycle)
3
Maximum Tolerated Dose (MTD) of Abemaciclib in Part A
Timeframe: Cycle 1 (21 Days)
4
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC0-tlast) of Abemaciclib in Part A
Timeframe: Pre-dose, 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
5
PK: (AUC0-tlast) of Irinotecan in Part A
Timeframe: 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)
6
PK: (AUC0-tlast) of Temozolomide in Part A
Timeframe: 1, 2.5, 4, and 6 hours post Day 1 dose of Cycle 1 and Cycle 2 (21 Day Cycle)