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

NCT04040205 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO34388
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Chondrosarcoma; Osteosarcoma; Soft Tissue Sarcoma

Keywords

Rb; Retinoblastoma; Chondrosarcoma; Osteosarcoma; Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  12 weeks

Study Arms (1)

Abemaciclib

EXPERIMENTAL

Subjects will be treated with abemaciclib 200 mg twice daily by mouth.

Drug: Abemaciclib

Interventions

Abemaciclib DRUG

Abemaciclib 200 mg will be taken by mouth twice daily.

Also known as: Verzenio

Abemaciclib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Metastatic or locally advanced disease that is unresectable
• There is no limit to the number of prior therapies a subject may have had, but the following requirements must be met:
• Conventional chondrosarcoma low-grade osteosarcoma, and chordoma: No requirements regarding prior therapy
• 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.
• Soft tissue sarcoma: at least 1 line of systemic therapy, unless the sarcoma subtype is one that is generally considered unresponsive to standard chemotherapy.
• Age ≥ 18 years.
• Provide study specific (step 1) informed consent prior to study entry
• Documented CDK pathway abnormality on a commercially available mutation profiling test (Foundation, Tempus xT, etc), if performed previously as part of routine/standard care on tumor (metastatic or primary), having at least one of the following (a and/or b)
• Cyclin D1 (CCND1), cyclin D2 (CCND2), cyclin D3 (CCND3), cyclin dependent kinase 4 (CDK4), and/or cyclin dependent kinase 6 (CDK6) amplification/copy number gain
• Cyclin Dependent Kinase Inhibitor 2A (CDKN2A) or CDKN2B copy number loss
• Provide study-specific (step 2) informed consent
• Rb positive confirmed by immunohistochemistry testing of archived tumor tissue specimen (metastatic or primary site) performed centrally at Medical College of Wisconsin Precision Medicine Laboratory.
• All subjects must have measurable disease as defined by RECIST 1.1. (See RECIST 1.1 criteria in Appendix 10.
• Subjects must also have had evidence of disease progression by RECIST 1.1 within 6 months of enrollment, or newly diagnosed within the last 6 months (refer to step 1 criteria regarding previous lines of therapy).
• A washout period of at least 21 days is required between last chemotherapy dose and enrollment.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (4)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Chondrosarcoma; Osteosarcoma; Sarcoma; Retinoblastoma

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• John Charlson, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: October 7, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)