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NCT03791398 · ClinicalTrials.gov registry record · Phase 1
BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC
A Phase 1 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT03791398: Clinical Trial Phase 1 study, sponsored by Brown University.
NCT03791398 is a Phase 1 study that was terminated before completion, run by Brown University. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03791398, a Phase 1 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a single arm Phase Ib/II, open label, safety, pharmacokinetic, pharmacodynamics and efficacy study of ONC201 in combination with Opdivo (Nivolumab) in adult patients with metastatic colorectal cancer, for whom no standard therapy is available. This study will enroll adult patients with metastatic colorectal cancer who progressed after at least two lines of therapy.
Interventions
- DRUG Dose level 1 ONC201 625mg
- DRUG Dose level 2 ONC201 500mg
- DRUG Dose level 3 ONC201 375mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2021-08-05 |
| Phase | Phase 1 |
Why NCT03791398 stopped before completion
NCT03791398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Dose level 1 ONC201 625mg is the first listed.
NCT03791398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03791398 about?
NCT03791398 is a clinical study titled "BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC". This is a single arm Phase Ib/II, open label, safety, pharmacokinetic, pharmacodynamics and efficacy study of ONC201 in combination with Opdivo (Nivolumab) in adult patients with metastatic colorectal cancer, for whom no standard therapy is available. This study will enroll adult patients with metas...
What is the current status of trial NCT03791398?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-11-15. Estimated completion is 2021-08-05.
What interventions are being tested in trial NCT03791398?
The interventions under investigation include: Dose level 1 ONC201 625mg (DRUG), Dose level 2 ONC201 500mg (DRUG), Dose level 3 ONC201 375mg (DRUG).
Who is sponsoring clinical trial NCT03791398?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03791398's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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