drugset / Trial / NCT04040205

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

NCT04040205

Phase 2 Recruiting 44 enrolled Medical College of Wisconsin
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-10-07
Primary completion
2027-06-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 200 mg Oral