OncoMatch/Clinical Trials/NCT04040205
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
Is NCT04040205 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Abemaciclib for chondrosarcoma.
Treatment: Abemaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Osteosarcoma
Sarcoma
Biomarker criteria
Required: CCND1 amplification
Cyclin D1 (CCND1)...amplification/copy number gain
Required: CCND2 amplification
cyclin D2 (CCND2)...amplification/copy number gain
Required: CCND3 amplification
cyclin D3 (CCND3)...amplification/copy number gain
Required: CDK4 amplification
cyclin dependent kinase 4 (CDK4)...amplification/copy number gain
Required: CDK6 amplification
cyclin dependent kinase 6 (CDK6)...amplification/copy number gain
Required: CDKN2A copy number loss
Cyclin Dependent Kinase Inhibitor 2A (CDKN2A)...copy number loss
Required: CDKN2B copy number loss
CDKN2B copy number loss
Required: RB1 Rb positive (positive)
Rb positive confirmed by immunohistochemistry testing of archived tumor tissue specimen
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline — adjuvant, neoadjuvant, or metastatic
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.
Must have received: systemic therapy
Soft tissue sarcoma: at least 1 line of systemic therapy, unless the sarcoma subtype is one that is generally considered unresponsive to standard chemotherapy.
Cannot have received: CDK4 inhibitor (palbociclib, abemaciclib, ribociclib)
Prior treatment with a specific CDK 4 or CDK 6 inhibitor - (such as palbociclib, abemaciclib, or ribociclib).
Cannot have received: CDK6 inhibitor (palbociclib, abemaciclib, ribociclib)
Prior treatment with a specific CDK 4 or CDK 6 inhibitor - (such as palbociclib, abemaciclib, or ribociclib).
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL (transfusion permitted, treatment not to begin before day after transfusion); Platelets ≥ 100 x 10^9/L
Kidney function
Estimated Creatinine Clearance (CrCl) ≥ 30 mL/min (Cockcroft-Gault), estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 (MDRD or CKD-EPI), or actual CrCl as determined by 24-hour urine collection
Liver function
Total bilirubin ≤ 1.5 x ULN (Gilbert's syndrome ≤2.0 x ULN and direct bilirubin within normal limits permitted); AST/ALT ≤ 3 x ULN
Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal): Hemoglobin ≥ 8.0 g/dL...Platelets ≥ 100 x 10^9/L...Total bilirubin ≤ 1.5 x ULN...AST/ALT ≤ 3 x 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 CKD-EPI), or actual CrCl as determined by 24-hour urine collection
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic · Jacksonville, Florida
- University of Iowa Hospitals and Clinics · Iowa City, Iowa
- Washington University in St. Louis · St Louis, Missouri
- Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, Wisconsin
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