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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: Clinical Trial Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Plan report patients proportions and their 95% confidence intervals of paitents who experience dose limiting toxicity. Determine best dose based on DLT criteria by CTCAE v5.0 * Thrombosis requiring anticoagulation * Ascites (grade 3-5) * Ovarian hyperstimulation syndrome
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 |
Why NCT05123040 stopped before completion
NCT05123040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Corticosteroids is the first listed.
NCT05123040 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05123040's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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