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NCT03733119 · ClinicalTrials.gov registry record · Phase 2
ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03733119: Clinical Trial Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT03733119 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03733119, a Phase 2 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
This phase II trial studies how well Akt/ERK inhibitor ONC201 (ONC201) with a methionine-restricted (MR) diet works in treating participants with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the death of a cell. ONC201 is able to target tumor cells to get rid of them, but does not affect normal cells. MR diet is a methionine-free amino acid modified medical food. The addition of an intermittent MR diet may enhance the activity of ONC201. Giving ONC201 and an MR diet may work better in treating participants with breast cancer.
Primary Outcome
ORR will be estimated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, by dividing the total number of responders (complete plus partial responses plus CR or PR) or (CR or PR), respectively, by number of subjects with measurable disease and the exact 95% confidence interval will be provided. Due to early termination with few participants, only the counts of events have been reported.
Interventions
- DRUG Akt/ERK Inhibitor ONC201
- DIETARY_SUPPLEMENT Methionine-Restricted Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2018-11-13 |
| Est. Completion | 2021-02-13 |
| Phase | Phase 2 |
Why NCT03733119 stopped before completion
NCT03733119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Akt/ERK Inhibitor ONC201 is the first listed.
NCT03733119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03733119 about?
NCT03733119 is a clinical study titled "ONC201 With a Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer". This phase II trial studies how well Akt/ERK inhibitor ONC201 (ONC201) with a methionine-restricted (MR) diet works in treating participants with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the de...
What is the current status of trial NCT03733119?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2018-11-13. Estimated completion is 2021-02-13.
What interventions are being tested in trial NCT03733119?
The interventions under investigation include: Akt/ERK Inhibitor ONC201 (DRUG), Methionine-Restricted Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03733119?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03733119's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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