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NCT03492138 · ClinicalTrials.gov registry record · Phase 1
Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by Ajai Chari.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03492138: Clinical Trial Phase 1 study, sponsored by Ajai Chari.
NCT03492138 is a Phase 1 study that was terminated before completion, run by Ajai Chari. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03492138, a Phase 1 study, was terminated before completion, sponsored by Ajai Chari.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
ONC201 is a novel dopamine receptor D2 antagonist that is able to activate the integrated stress response pathway. It is active against multiple myeloma cells in vitro, both as a single agent and in combination with corticosteroids and proteasome inhibitors. In order to document superiority over the combination compared to the individual agents of ixazomib and ONC201 in a single arm study, there will initially be a run-in period of weekly ONC201 625 mg with dexamethasone 40 mg such that if there is progression of disease (25% increase) after 4 weeks or less than a minimal response (25% reduction) after 8 weeks then ixazomib will be added. Dexamethasone is dose-reduced to 20 mg at the same schedule for subjects ≥ 75 years old. If patients do achieve single-agent responses with ONC201 (minimal response or better), they will continue with weekly ONC201 and dexamethasone until progression, with response assessments after each 28-day cycle. Patients who have previously been treated on another clinical trial with weekly ONC201 625mg with dexamethasone with progression while receiving treatment do not need to complete the run-in phase of the study. At the time of progression, they will proceed to the 3 drug combination phase of the study. It is at the point of 3 drug initiation, that below phase I DLT principles or phase II disease control rate considerations apply.
Interventions
- DRUG Dexamethasone
- DRUG ONC201
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-03-26 |
| Est. Completion | 2020-01-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03492138
The ClinicalTrials.gov registry entry for NCT03492138 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ajai Chari, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT03492138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03492138 about?
NCT03492138 is a clinical study titled "Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma". ONC201 is a novel dopamine receptor D2 antagonist that is able to activate the integrated stress response pathway. It is active against multiple myeloma cells in vitro, both as a single agent and in combination with corticosteroids and proteasome inhibitors. In order to document superiority over the...
What is the current status of trial NCT03492138?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-03-26. Estimated completion is 2020-01-14.
What interventions are being tested in trial NCT03492138?
The interventions under investigation include: Dexamethasone (DRUG), ONC201 (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT03492138?
This trial is sponsored by Ajai Chari, which has 4 total clinical trials registered on ClinicalTrials.gov.
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