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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 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 4 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03733119
The ClinicalTrials.gov registry entry for NCT03733119 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Akt/ERK Inhibitor ONC201 is the first listed.
NCT03733119 reports 0 study locations.
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.
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