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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Medical College of Wisconsin
Study ID
NCT04040205
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chondrosarcoma
  • Osteosarcoma
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Abemaciclib 200 mg will be taken by mouth twice daily.

Study Details

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.

Key Dates

Start date
Oct 7, 2019
Status verified
Jul 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Abemaciclib
    Subjects will be treated with abemaciclib 200 mg twice daily by mouth.

Primary Outcome Measure

Progression-free survival [ Time Frame: 12 weeks ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
Steven Attia, DO
[email protected]
University of Iowa Hospitals and ClinicsIowa CityIowa52242
John Rieth, MD
[email protected]
319-356-1616
Washington University in St. LouisSt LouisMissouri63130
Michele Landeau, CCRP
[email protected]
314-747-9488
Brian Van Tine, MD (PRINCIPAL_INVESTIGATOR)
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
John Charlson, MD
[email protected]
414-805-4600
John Charlson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic· Jacksonville, FLUniversity of Iowa Hospitals and Clinics· Iowa City, IAWashington University in St. Louis· St Louis, MOFroedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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