Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors
Completed · Phase 1
Conditions studied: 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
In brief
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).
Key facts
- Study ID
- NCT02644460
- Run by
- Emory University
- People needed
- 53
- Starts
- 2016-02-01
- Expected to finish
- 2023-10-10
- Last updated by the study team
- 2023-10-26
Who can join
Age: 2 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients with uncontrolled infection
- Patients with any concomitant significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, or that would impair the evaluation of side effects related to this treatment, alter drug metabolism or the tolerance to this treatment
- Patients receiving any other anticancer or investigational drug therapy
- Prior therapy with abemaciclib
- Known mutation of Rb in tumor tissue
- Prior history of QTC prolongation or QTC>450 ms on screening ECG.
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Children's Healthcare of Atlanta, Egleston — Atlanta, Georgia, United States
- Children's Healthcare of Atlanta, Scottish Rite — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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