Actively Recruiting
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
Led by Medical College of Wisconsin · Updated on 2025-07-20
44
Participants Needed
4
Research Sites
399 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 allowed with specific requirements based on sarcoma subtype
- Age 18 years or older
- Provide informed consent
- Documented CDK pathway abnormality on tumor profiling test
- Confirmed Rb positive by immunohistochemistry testing
- Measurable disease by RECIST 1.1 criteria
- Disease progression within 6 months or newly diagnosed within 6 months
- At least 21 days since last chemotherapy
- At least 14 days since radiotherapy
- At least 14 days after surgery with no significant wound healing issues
- Treated and stable brain metastases for at least 3 months allowed
- ECOG performance status 0 or 1
- Adequate organ and marrow function
- Female subjects must be postmenopausal, surgically sterile, or use contraception
- Male subjects must use barrier contraception or abstinence
- Ability to comply with study plan
- Ability to swallow oral medications
You will not qualify if you...
- Diagnosis of well differentiated or dedifferentiated liposarcoma
- Prior treatment with CDK 4 or CDK 6 inhibitors
- Not recovered from acute effects of chemotherapy except alopecia or Grade 2 neuropathy
- Receiving other investigational agents
- Current treatment with strong CYP3A inducers or inhibitors
- Uncontrolled infections or illnesses including active HIV or hepatitis
- Symptomatic heart failure, unstable angina, arrhythmias, or psychiatric illness limiting compliance
- History of syncope or ventricular arrhythmia of cardiac origin
- Pregnant or breastfeeding women
- Evidence of another malignancy requiring treatment
- Treatment with live attenuated viruses within 30 days prior or during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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