Actively Recruiting
Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration
Led by Medical College of Wisconsin · Updated on 2025-07-20
44
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of abemaciclib in patients with advanced bone and soft tissue sarcomas who have specific changes in the Cyclin D1 - CDK4/6 - Rb pathway. It focuses on adults with metastatic or unresectable sarcoma types excluding dedifferentiated liposarcoma, to identify those most likely to benefit from CDK4/6 inhibition. The study is a phase II, single-arm trial enrolling 45 subjects divided into three cohorts representing different sarcoma subtypes. Participants will receive abemaciclib, taken orally at a dose of 200 mg twice daily, until the disease progresses or other criteria require stopping treatment. The cohorts include patients with conventional chondrosarcoma, osteosarcoma or dedifferentiated chondrosarcoma, and soft tissue sarcoma (excluding certain liposarcomas). Treatment continues with monitoring of disease status and side effects throughout the study period. During the trial, participants will undergo assessments including tumor measurement by RECIST 1.1 criteria, confirmation of Rb protein status by immunohistochemistry, and evaluation of disease progression over 12 weeks. Eligibility requires adequate organ function, performance status, and compliance ability. The primary outcome measured is progression-free survival at 12 weeks. Safety and response will be closely monitored until progression or discontinuation, with total participation time depending on individual treatment duration.
CONDITIONS
Brief Title
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma
- Metastatic or locally advanced disease that cannot be removed by surgery
- Prior therapies as required by sarcoma subtype, including chemotherapy when applicable
- Age 18 years or older
- Provide informed consent before study entry
- Documented CDK pathway abnormality from tumor testing
- Confirmed Rb protein positive by immunohistochemistry
- Measurable disease by RECIST 1.1 criteria
- Evidence of disease progression within 6 months or newly diagnosed within 6 months
- Required washout periods after chemotherapy, radiotherapy, and surgery
- Stable brain metastasis if previously treated and stable for 3 months
- ECOG performance status 0 or 1
- Adequate organ and marrow function as defined
- Female participants must meet contraception or sterilization requirements
- Male participants must agree to contraception or abstinence
- Ability to comply with study plan and swallow oral medication
You will not qualify if you...
- Diagnosis of well differentiated or dedifferentiated liposarcoma
- Prior treatment with CDK 4 or CDK 6 inhibitors such as abemaciclib, palbociclib, or ribociclib
- Not recovered from acute chemotherapy effects (except specific exceptions) or serious preexisting medical conditions
- Current use of other investigational agents
- Current treatment with strong CYP3A inducers or inhibitors
- Uncontrolled infections or illnesses, including active viral infections or serious heart conditions
- History of significant cardiac arrhythmias or sudden cardiac arrest
- Pregnant or breastfeeding women
- Presence of another malignancy requiring treatment
- Recent treatment with live attenuated vaccines or plans to receive during trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive abemaciclib 200 mg by mouth twice daily to treat their sarcoma.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 4 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
4
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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