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Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
NCT04040205 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Abemaciclib
Study Locations (4)
Florida
- Mayo Clinic — Jacksonville
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
Missouri
- Washington University in St. Louis — St Louis
Wisconsin
- Froedtert Hospital & the Medical College of Wisconsin — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04040205
The ClinicalTrials.gov registry entry for NCT04040205 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 614 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 1 intervention — of which Abemaciclib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04040205 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Florida, Iowa, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04040205 about?
NCT04040205 is a clinical study titled "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 subm...
What is the current status of trial NCT04040205?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2019-10-07. Estimated completion is 2027-06-01.
What conditions does trial NCT04040205 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma, Osteosarcoma, Chondrosarcoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04040205?
The interventions under investigation include: Abemaciclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04040205?
This trial is sponsored by Medical College of Wisconsin, which has 614 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04040205 being conducted?
This trial has 4 study locations across Florida, Iowa, Missouri, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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