NCT02644460

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

Abemaciclib in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma, and in Children With Recurrent and Refractory Solid Tumors Including Malignant Brain Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).

Detailed description

Stratum A- Appropriate dose RT will be administered in 30-33 fractions over approximately 6 weeks for Stratum A patients. Treatment with abemaciclib (LY2835219) will start on the same day as radiation therapy (RT) and continue twice daily during and after RT for a maximum treatment duration of 2 years. Investigators plan to treat a maximum of 4 cohorts of research participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib (LY2835219) starting with dose level 1 (80% of adult dose). A cycle is defined as 28 days and the first 6 weeks of therapy will constitute the dose-limiting toxicity (DLT)-evaluation period. Participants must take abemaciclib by mouth as intact capsules. Stratum B (no longer enrolling) - Abemaciclib (LY2835219) will be administered orally on a twice daily basis continuously for 28 days, which defines one cycle. The maximum treatment duration will be 2 years. Investigators plan to treat a maximum of 4 cohorts of research participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib starting with dose level 1 (80% of adult dose). Dose escalation will be independent of Stratum A escalation. A cycle is defined as 28 days and the first 4 weeks of therapy will constitute the DLT-evaluation period. Participants must take abemaciclib by mouth as intact capsules. Enrollment for Stratum B closed December 27, 2018.

Conditions

• Diffuse Intrinsic Pontine Glioma
• Brain Tumor, Recurrent
• Solid Tumor, Recurrent
• Neuroblastoma, Recurrent, Refractory
• Ewing Sarcoma, Recurrent, Refractory
• Rhabdomyosarcoma, Recurrent, Refractory
• Osteosarcoma, Recurrent, Refractory
• Rhabdoid Tumor, Recurrent, Refractory

Interventions

Type	Name	Description
DRUG	Abemaciclib

Timeline

• Start date: 2016-02-01
• Primary completion: 2023-10-10
• Completion: 2023-10-10
• First posted: 2015-12-31
• Last updated: 2023-10-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study