RecruitingPhase 2NCT04040205

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

Abemaciclib for Treatment of Advanced Bone and Soft Tissue Sarcoma Identified as Having CDK Pathway Alteration


Sponsor

Medical College of Wisconsin

Enrollment

44 participants

Start Date

Oct 7, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests abemaciclib — a drug already approved for breast cancer — in patients with bone or soft tissue sarcomas whose tumors have a specific molecular defect (overexpression of CDK4 or amplification of the CDK4 gene). The idea is that the same molecular vulnerability found in breast cancer may exist in some sarcomas. **You may be eligible if...** - You have a bone or soft tissue sarcoma that has spread or cannot be surgically removed - Your tumor shows CDK4 overexpression or CDK4 gene amplification on testing - You have received at least one prior line of therapy - You are 18 or older and in adequate general health **You may NOT be eligible if...** - Your tumor does not have CDK4 amplification or overexpression - You have had too many prior lines of therapy (specific limits apply) - You have serious heart problems or other significant medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

Abemaciclib 200 mg will be taken by mouth twice daily.


Locations(4)

Mayo Clinic

Jacksonville, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Washington University in St. Louis

St Louis, Missouri, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT04040205


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