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NCT01881789 · ClinicalTrials.gov registry record · Phase 1
Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01881789 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 22 participants.
The verdict
NCT01881789, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary objectives of this study included the following: Phase 1b: * To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or with cyclophosphamide and dexamethasone (OCyd) * To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide Phase 2: * To estimate the antitumor activity of each combination regimen, as measured by overall response rate (ORR) and complete response rate (CRR) * To evaluate the safety and tolerability of each combination regimens, as assessed by the type, incidence, severity and seriousness of adverse events, and abnormalities in selected laboratory analytes
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Oprozomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-10-28 |
| Est. Completion | 2019-09-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01881789
The ClinicalTrials.gov registry entry for NCT01881789 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01881789 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01881789 about?
NCT01881789 is a clinical study titled "Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma". The primary objectives of this study included the following: Phase 1b: * To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or with cyclophosphamide and dexamethasone (OCyd) * To evaluate the safety and tolerability of oprozomi...
What is the current status of trial NCT01881789?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2013-10-28. Estimated completion is 2019-09-23.
What interventions are being tested in trial NCT01881789?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Oprozomib (DRUG).
Who is sponsoring clinical trial NCT01881789?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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