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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 is a Phase 1 study that has completed, run by Oncotherapeutics. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02206425
The ClinicalTrials.gov registry entry for NCT02206425 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oncotherapeutics, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02206425 reports 0 study locations.
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.
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