RecruitingChondrosarcomaOsteosarcomaSoft Tissue Sarcoma
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
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About this study
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.
Sponsor: Medical College of Wisconsin
You may qualify if…
- ✓ 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 combination, required either as adjuvant, neoadjuvant or in the metastatic setting. If anthracycline chemotherapy is contraindicated, alternative prior first line chemotherapy is acceptable.
- ✓ 3. Soft tissue sarcoma: at least 1 line of systemic therapy, unless the sarcoma subtype is one that is generally considered unresponsive to standard chemotherapy.
- ✓ 4. Age ≥ 18 years.
- ✓ 5. Provide study specific (step 1) informed consent prior to study entry
You may not qualify if…
- ✕ 1. Diagnosis of well differentiated (WD) or dedifferentiated (DD) liposarcoma
- ✕ 2. Prior treatment with a specific CDK 4 or CDK 6 inhibitor - (such as palbociclib, abemaciclib, or ribociclib).
- ✕ 3. Subjects who have not recovered (Common Terminology Criteria for Adverse Events \[CTCAE v5.0\] Grade ≤1) from the acute effects of chemotherapy (except for residual alopecia or Grade 2 peripheral neuropathy) prior to enrollment, or other toxicity or serious preexisting medical condition(s) (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) that in the opinion of the site PI is expected to preclude participation in this study.
- ✕ 4. Subjects currently receiving any other investigational agents.
- ✕ 5. Current ongoing treatment with strong Cytochrome P450, family 3, subfamily A (CYP3A) inducers or inhibitors.
- ✕ 6. Uncontrolled intercurrent illness including, but not limited to, known ongoing or active bacterial infection (requiring IV antibiotics), fungal infection, detectable viral infection (such as known HIV or active hepatitis B or C) (screening tests is not required for enrollment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial fibrillation or ventricular dysrhythmias except ventricular premature contractions), or psychiatric illness/social situations that would limit compliance with study requirements.
- ✕ 7. The subject has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
- ✕ 8. Pregnant women and women who are breast-feeding.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04040205 · last updated 2025-07-20