NCT04238819

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 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Solid Tumor
• Refractory Solid Tumor

Interventions

Type	Name	Description
DRUG	Abemaciclib	Administered orally
DRUG	Irinotecan	Administered IV
DRUG	Temozolomide	Administered orally
DRUG	Dinutuximab	Administered IV
DRUG	GM-CSF	Administered SC

Timeline

• Start date: 2020-11-09
• Primary completion: 2024-03-15
• Completion: 2025-08-19
• First posted: 2020-01-23
• Last updated: 2026-03-02
• Results posted: 2025-08-06

Locations

25 sites across 8 countries: United States, Australia, Belgium, France, Germany, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study