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NCT04040205 · ClinicalTrials.gov registry record · Phase 2
Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration
A Phase 2 study of Soft Tissue Sarcoma and Osteosarcoma, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 4
- Study locations
NCT04040205: Recruiting Phase 2 study of Soft Tissue Sarcoma and Osteosarcoma, sponsored by Medical College of Wisconsin.
NCT04040205 is a Phase 2 study of Soft Tissue Sarcoma and Osteosarcoma that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 44 participants, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (44% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04040205, a Phase 2 study of Soft Tissue Sarcoma and Osteosarcoma, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
This outcome measure is the number of subjects whose disease has not progressed as defined by RECIST 1.1 criteria.
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 |
What NCT04040205 shows while recruiting
NCT04040205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (44% lower).
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.
NCT04040205 reports a single indexed study location in Florida, Iowa, Missouri.
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.
What interventions are being tested in trial NCT04040205?
The interventions under investigation include: Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT04040205?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Soft Tissue Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04040205's enrollment target sits among peer trials
44 25th of 55 higher than 31 of 55 other Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Soft Tissue Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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