Study on Abemaciclib for Bone and Soft Tissue Sarcoma with CDK Pathway Changes

Inclusion Criteria

• Have a diagnosis of soft tissue sarcoma or specific types of bone sarcoma like chondrosarcoma or osteosarcoma.
• The cancer must be advanced and cannot be removed by surgery.
• No limit on previous treatments, but certain types of sarcoma require specific prior therapies.
• Be 18 years or older.
• Agree to participate and provide informed consent.
• Have a specific genetic change in the CDK pathway, confirmed by a test.
• Have a positive Rb test from a tumor sample.
• Have measurable cancer as defined by specific criteria.
• Show evidence of cancer progression within 6 months or be newly diagnosed within the last 6 months.
• Have a break of at least 21 days after the last chemotherapy and 14 days after radiotherapy before joining the study.
• Be at least 14 days post-surgery with no significant wound healing issues.
• Have stable brain metastases if previously treated.
• Have a performance status of 0 or 1, indicating good overall health.
• Have adequate organ and blood function based on specific tests.
• Women must meet specific criteria regarding pregnancy and contraception.
• Men must agree to use contraception or abstain from intercourse during the study.
• Be able to comply with the study plan and take oral medications.

Exclusion Criteria

• Have a diagnosis of well-differentiated or dedifferentiated liposarcoma.
• Have previously been treated with CDK4 or CDK6 inhibitors like Abemaciclib.
• Have not recovered from previous chemotherapy side effects or have other serious medical conditions.
• Are currently receiving other investigational treatments.
• Are taking certain medications that affect the liver enzyme CYP3A.
• Have uncontrolled illnesses or infections.
• Have a history of certain heart conditions.
• Are pregnant or breastfeeding.
• Have another cancer that requires treatment.
• Have received live vaccines within 30 days before joining the study.