Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors — AflacST1501  

Diffuse Intrinsic Pontine Glioma Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02644460
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Completion date: October 10, 2023