NCT04040205

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

Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, phase II study that will enroll a total of 45 subjects. All subjects will have a confirmed diagnosis of metastatic or unresectable soft tissue sarcoma or bone sarcoma. All subjects must have intact Rb, identified at the time of screening, by immunohistochemistry testing of submitted tumor specimen. Subjects will receive Abemaciclib 200 mg twice daily until progression or discontinuation criteria are met.

Detailed description

Population to be studied: Since abemaciclib is already being studied in dedifferentiated liposarcoma patients, patients with this sarcoma subtype will not be enrolled in the current study. This exploratory study will enroll patients with all other types of soft tissue sarcoma, in addition to patients with several bone sarcomas. We are testing the hypothesis that biomarkers of Cyclin D1 - CDK4/6 - Rb pathway activation will identify patients with a rare, heterogeneous cancer who are most likely to benefit from cyclin-dependent kinase 4/6 (CDK4/6) inhibition with abemaciclib. There will be three cohorts of patients, intended to ensure representation of subjects with rare bone sarcomas - chondrosarcoma and osteosarcoma - that have relatively frequent occurrence of abnormalities in the Cyclin D1 - CDK4/6 - Rb pathway, in addition to soft tissue sarcoma. Cohort 1 - Conventional chondrosarcoma, 9-12 patients; Cohort 2 - Osteosarcoma, Dedifferentiated chondrosarcoma, 9-12 patients; Cohort 3 - Soft tissue sarcoma (except WD/DD Liposarcoma), 22-26 patients

Conditions

• Chondrosarcoma
• Osteosarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Abemaciclib 200 mg will be taken by mouth twice daily.

Timeline

• Start date: 2019-10-07
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2019-07-31
• Last updated: 2025-07-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study