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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 is a Phase 1 study that was terminated before completion, run by Brown University. The registered enrollment target is 13 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03791398
The ClinicalTrials.gov registry entry for NCT03791398 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dose level 1 ONC201 625mg is the first listed.
NCT03791398 reports 0 study locations.
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.
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