Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration
Medical College of Wisconsin
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.
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 thr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma (see exclusion criteria below) 2. Metastatic or locally advanced disease that is unresectable 3. There is no limit to the number of prior therapies a subject may have had, but the following requirements must be met: 1. Conventional chondrosarcoma low-grade osteosarcoma, and chordoma: No requirements regarding prior therapy 2. Osteosarcoma (high-grade), Dedifferentiated chondrosarcoma: at least 1 prior anthracycline chemotherapy, alone or in…
Interventions
- DrugAbemaciclib
Abemaciclib 200 mg will be taken by mouth twice daily.
Locations (4)
- Mayo ClinicJacksonville, Florida
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Washington University in St. LouisSt Louis, Missouri
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin