Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-07-29; most recent amendment 2025-07-16.
Status change: Not Yet Recruiting → Recruiting 2019-10-08
Trial Details
NCT Number NCT04040205
Lead Sponsor Medical College of Wisconsin
Conditions Chondrosarcoma, Osteosarcoma, Soft Tissue Sarcoma
Enrollment 44 participants
Start Date 2019-10-07
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-28