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NCT02206425 · ClinicalTrials.gov registry record · Phase 1
Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients
A Phase 1 study, sponsored by Oncotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT02206425: Completed Phase 1 study, sponsored by Oncotherapeutics.
NCT02206425 is a Phase 1 study that has completed, run by Oncotherapeutics. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02206425, a Phase 1 study, has completed, sponsored by Oncotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of ixazomib given as part of a combination therapy to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma. More specifically, the study is focused on subjects who were previously treated with bortezomib (Velcade®) or carfilzomib (Kyprolis®) and showed worsening of their myeloma while receiving either one of these drugs in combination therapy. This study is a Phase I/II. Ixazomib is an investigational drug, which means that ixazomib is currently being tested and is not yet approved by the United States Food and Drug Administration (FDA) for subjects with relapsed or refractory multiple myeloma. Ixazomib is a new study drug that belongs to the same class as bortezomib and carfilzomib; however, unlike bortezomib and carfilzomib, ixazomib is taken by mouth. Current studies investigating ixazomib are demonstrating that it is as safe as bortezomib and effective for the treatment of multiple myeloma both on its own and in combination with other multiple myeloma medications, such as lenalidomide and dexamethasone, or prednisone and melphalan.
Primary Outcome
MTD determined via the number of dose-limiting toxicities (DLTs) per cohort for the following ixazomib- containing combinations: bortezomib+ cyclophosphamide + dexamethasone, bortezomib + cyclophosphamide + ascorbic acid, bortezomib + PLD + dexamethasone
Interventions
- DRUG Cyclophosphamide
- DRUG Melphalan
- DRUG Dexamethasone
- DRUG Prednisone
- DIETARY_SUPPLEMENT Ascorbic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-09 |
| Est. Completion | 2018-03-06 |
| Phase | Phase 1 |
What the finished NCT02206425 record still lists
NCT02206425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02206425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02206425 about?
NCT02206425 is a clinical study titled "Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients". The goal of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of ixazomib given as part of a combination therapy to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) m...
What is the current status of trial NCT02206425?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-09. Estimated completion is 2018-03-06.
What interventions are being tested in trial NCT02206425?
The interventions under investigation include: Cyclophosphamide (DRUG), Melphalan (DRUG), Dexamethasone (DRUG), Prednisone (DRUG), Ascorbic acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02206425?
This trial is sponsored by Oncotherapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02206425's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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