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NCT04807777 · ClinicalTrials.gov registry record · Phase 2
Study of Ruxolitinib in Solid Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
A Phase 2 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04807777 is a Phase 2 study that was terminated before completion, run by Columbia University. The registered enrollment target is 3 participants.
The verdict
NCT04807777, a Phase 2 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
In this open-label, multicenter, Phase II study, the investigators propose to evaluate the efficacy of ruxolitinib, an orally administered inhibitor of JAK1/2, in solid organ transplant recipients with advanced cSCC. In a safety lead-in of 6 patients, subjects will receive ruxolitinib 15mg twice daily (BID). After 4 weeks, if dose-limiting toxicities (DLT) are observed in 1 or fewer patients, the study will enter stage 1 of the Simon two-stage design where all subsequent patients will receive a starting dose of ruxolitinib 15mg BID. If more than 1 DLTs are observed, another cohort of 6 patients will be treated at a dose of 10mg BID. If less than 2 DLTs are observed at the new dose of 10mg, then the study will proceed to stage I using this dose; otherwise the study will stop.
Interventions
- DRUG Ruxolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-04-07 |
| Est. Completion | 2023-10-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04807777
The ClinicalTrials.gov registry entry for NCT04807777 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT04807777 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04807777 about?
NCT04807777 is a clinical study titled "Study of Ruxolitinib in Solid Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma". In this open-label, multicenter, Phase II study, the investigators propose to evaluate the efficacy of ruxolitinib, an orally administered inhibitor of JAK1/2, in solid organ transplant recipients with advanced cSCC. In a safety lead-in of 6 patients, subjects will receive ruxolitinib 15mg twice dai...
What is the current status of trial NCT04807777?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2022-04-07. Estimated completion is 2023-10-04.
What interventions are being tested in trial NCT04807777?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04807777?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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