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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). 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.
Primary Outcome
of triplet therapy (ixazomib + ONC201+ dexamethasone) following a 3+3 escalation design
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 |
Why NCT03492138 stopped before completion
NCT03492138 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT03492138 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03492138's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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