Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of soft tissue sarcoma or conventional chondrosarcoma, dedifferentiated chondrosarcoma, chordoma, or osteosarcoma (see
Disqualifiers
Metastatic or locally advanced disease that is unresectable
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.
Trial design
Design model
Single group
Treatments tested in this trial
Abemaciclib
DrugAbemaciclib 200 mg will be taken by mouth twice daily.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: AbemaciclibExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov