Abemaciclib for Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Abemaciclib, a cancer medication taken by mouth, in patients with advanced soft tissue and bone sarcomas. The drug works by blocking proteins that help cancer cells grow and divide.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of at least 21 days after the last chemotherapy dose and 14 days after the end of radiotherapy before enrollment. Additionally, you cannot be on strong CYP3A inducers or inhibitors during the trial.
How is the drug Abemaciclib unique for treating sarcoma?
What data supports the effectiveness of the drug Abemaciclib for treating sarcoma?
Who Is on the Research Team?
John Charlson, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Adults with certain types of advanced sarcomas (like osteosarcoma, chondrosarcoma) that can't be surgically removed and have specific CDK pathway changes. They should not have had prior treatment with CDK4/6 inhibitors, must show disease progression recently or be newly diagnosed, and their organs must function well. Women of childbearing potential need to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Abemaciclib 200 mg twice daily until progression or discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
Abemaciclib is already approved in United States, European Union for the following indications:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor