drugset / Trial / NCT04238819
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-11-09
- Primary completion
- 2024-03-15
- Completion
- 2025-08-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 55 mg/m2 | Oral |
| Subject | Abemaciclib | Small molecule | 70 mg/m2 | Oral |
| Subject | Abemaciclib | Small molecule | 90 mg/m2 | Oral |
| Subject | Abemaciclib | Small molecule | 115 mg/m2 | Oral |
| Subject | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Subject | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |