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Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

NCT02644460 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-10-26

No results posted yet for this study

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).

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

DRUG

Abemaciclib

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Thomas Cash, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2023-10-10
Completion
2023-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644460 on ClinicalTrials.gov