Back to search results

Abemaciclib for Sarcoma with CDK Pathway Alteration

This study is testing a drug called abemaciclib for people with certain types of advanced or metastatic (spread to other parts of the body) bone and soft tissue sarcomas. These include chondrosarcoma, osteosarcoma, and other soft tissue sarcomas. Researchers want to see if abemaciclib can help by targeting specific changes in cancer cells related to the CDK pathway. You would take abemaciclib 200 mg by mouth twice daily. The main goal is to see how long people live without their cancer growing or spreading, measured at 12 weeks. To join, you must be 18 or older, have intact Rb (a protein in cells) identified in your tumor, and have a sarcoma that is unresectable (cannot be removed by surgery). The study plans to enroll 44 people.

Study design
This is a single-arm, phase II study, meaning all 44 participants will receive the same treatment. It is not specified if the study is blinded.
What's involved
You would take abemaciclib 200 mg by mouth twice daily until your cancer progresses or you need to stop for other reasons.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival, is measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04040205

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Medical College of Wisconsin
~44 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Abemaciclib

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival
Measured over 12 weeks

Conditions

Chondrosarcoma
Osteosarcoma
Soft Tissue Sarcoma

Explore related trials

ChondrosarcomaChordomaOsteosarcomaSoft Tissue SarcomaCCND1 GeneCCND3 GeneCDK4 GeneCDK6 GeneCDKN2A GeneCyclin-Dependent Kinase 4 Inhibitor BG1/S-Specific Cyclin-D2RB1 wt Allele

Where it's being run

4 sites across 4 states
Florida1
Iowa1
Missouri1
Wisconsin1

Study leadership

  • John Charlson, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Medical College of Wisconsin Cancer Center Clinical Trials Office
[email protected]
866-680-0505 · ext. 8900
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Hemoglobin ≥ 8.0 g/dL
Platelets ≥ 100 x 10\^9/L
Total bilirubin ≤ 1.5 x ULN
Aspartate aminotransferase (AST)(SGOT)/alanine aminotransferase (ALT)(SGPT) ≤ 3 x institutional ULN
Renal function (at least one of the following): Estimated Creatinine Clearance (CrCl) ≥ 30 mL/min (Cockcroft-Gault), estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m\^2 (MDRD or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula), or actual CrCl as determined by 24-hour urine collection 17. Female subjects must meet one of the following:
Postmenopausal for at least one year before enrollment, OR
Surgically sterile (i.e. undergone a hysterectomy or bilateral oophorectomy), OR
If subject is of childbearing potential (defined as not satisfying either of the above two criteria), must have a negative serum pregnancy test within 21 days of step 2 enrollment AND
Agree to practice two acceptable methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom with spermicidal agent added, hormonal contraceptive) from the time of signing of the informed consent form through 90 days after the last dose of study agent, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable contraception methods.) 18. Male subjects, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:
Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post ovulation methods\] and withdrawal are not acceptable methods of contraception.) 19. Subjects must be deemed able to comply with the study plan by the local PI. 20. Ability to swallow oral medications

What this trial measures

  • Progression-free survival12 weeks

    This outcome measure is the number of subjects whose disease has not progressed as defined by RECIST 1.1 criteria.