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NCT04541225 · ClinicalTrials.gov registry record · Phase 1
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
A Phase 1 study, sponsored by Nuvation Bio.
- Terminated
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT04541225: Clinical Trial Phase 1 study, sponsored by Nuvation Bio.
NCT04541225 is a Phase 1 study that was terminated before completion, run by Nuvation Bio. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04541225, a Phase 1 study, was terminated before completion, sponsored by Nuvation Bio.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422. The study population comprised adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and without brain metastases, and recurrent or refractory metastatic castration-resistant prostate cancer (mCRPC). All patients self-administered NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
Primary Outcome
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Interventions
- DRUG NUV-422
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 1 |
Why NCT04541225 stopped before completion
NCT04541225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 1 intervention - of which NUV-422 is the first listed.
NCT04541225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04541225 about?
NCT04541225 is a clinical study titled "Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors". At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422. The study population comprised adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and...
What is the current status of trial NCT04541225?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2020-12-08. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT04541225?
The interventions under investigation include: NUV-422 (DRUG).
Who is sponsoring clinical trial NCT04541225?
This trial is sponsored by Nuvation Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04541225's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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