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NCT04238819 · ClinicalTrials.gov registry record · Phase 1
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT04238819: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT04238819 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04238819, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 50 mg/m²/day irinotecan and 100 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
Interventions
- DRUG Temozolomide
- DRUG Abemaciclib
- DRUG Irinotecan
- DRUG GM-CSF
- DRUG Dinutuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2025-08-19 |
| Phase | Phase 1 |
What the finished NCT04238819 record still lists
NCT04238819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 5 interventions - of which Temozolomide is the first listed.
NCT04238819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04238819 about?
NCT04238819 is a clinical study titled "A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma". 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 partici...
What is the current status of trial NCT04238819?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-11-09. Estimated completion is 2025-08-19.
What interventions are being tested in trial NCT04238819?
The interventions under investigation include: Temozolomide (DRUG), Abemaciclib (DRUG), Irinotecan (DRUG), GM-CSF (DRUG), Dinutuximab (DRUG).
Who is sponsoring clinical trial NCT04238819?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04238819's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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