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

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.

Trial Details

NCT ID

NCT04040205

Phase

PHASE2

Sponsor

Medical College of Wisconsin

Status

RECRUITING

Cancer Type

Sarcoma

Interventions

Abemaciclib

Locations (sample)

Jacksonville, Florida, United States|30.33218,-81.65565
Iowa City, Iowa, United States|41.66113,-91.53017
St Louis, Missouri, United States|38.62727,-90.19789
Milwaukee, Wisconsin, United States|43.0389,-87.90647

Key Eligibility Criteria

Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma (see exclusion criteria…
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

For full eligibility, visit ClinicalTrials.gov.

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