Abemaciclib Treatment for Adults With Advanced Bone and Soft Tissue Sarcoma Showing CDK Pathway Changes

What this Trial Is About

This trial is a phase II, single-group study enrolling 45 participants diagnosed with metastatic or unresectable soft tissue sarcoma or bone sarcoma, excluding dedifferentiated liposarcoma. It focuses on patients whose tumors show activation of the Cyclin D1 - CDK46 - Rb pathway, aiming to identify those who may respond to CDK46 inhibition. The study includes three patient cohorts conventional chondrosarcoma, osteosarcoma with dedifferentiated chondrosarcoma, and soft tissue sarcoma excluding certain subtypes. Participants will receive oral abemaciclib at a dose of 200 mg twice daily until the disease progresses or they meet criteria to stop treatment. The treatment is the same for all participants, and dosing continues throughout the study period. Patients must have intact Rb protein confirmed via tumor testing at the Medical College of Wisconsin laboratory. During the study, participants will be monitored for disease progression using criteria that evaluate tumor size and spread. The primary outcome measure is progression-free survival assessed at 12 weeks. Participants will undergo regular assessments, including tumor measurements and organ function tests, to ensure safety and track treatment effects. The study will continue until completion in 2027, with ongoing evaluation of response and side effects.

Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration