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NCT05123040 · ClinicalTrials.gov registry record · Phase 1
Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05123040 is a Phase 1 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 10 participants.
The verdict
NCT05123040, a Phase 1 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This multi-center center phase I/II study to establish the lowest possible recommended phase 2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel combination) for high-risk aGVHD. This is a single arm study designed to determine the lowest dose of corticosteroids required (toxicity endpoint) without impairing GVHD complete response or partial response (CR/PR) at day 28 when given in conjunction with uhCG/EGF and ruxolitinib. After completion of the corticosteroid dose finding, the final dose will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of efficacy of this novel drug combination for high-risk aGVHD.
Interventions
- DRUG Corticosteroids
- DRUG hCG
- DRUG Ruxolitinib 10 MG Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2026-02-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05123040
The ClinicalTrials.gov registry entry for NCT05123040 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Corticosteroids is the first listed.
NCT05123040 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05123040 about?
NCT05123040 is a clinical study titled "Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids". This multi-center center phase I/II study to establish the lowest possible recommended phase 2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel combination) for high-risk aGVHD. This is a single arm study designed to determine the lowest dose of corticosteroids r...
What is the current status of trial NCT05123040?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-06-05. Estimated completion is 2026-02-27.
What interventions are being tested in trial NCT05123040?
The interventions under investigation include: Corticosteroids (DRUG), hCG (DRUG), Ruxolitinib 10 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05123040?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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