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NCT02281084 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
A Phase 2 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT02281084 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 65 participants.
The verdict
NCT02281084, a Phase 2 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment. Extension: An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.
Interventions
- DRUG Durvalumab
- DRUG Oral Azacitidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2015-07-06 |
| Est. Completion | 2023-09-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02281084
The ClinicalTrials.gov registry entry for NCT02281084 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT02281084 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02281084 about?
NCT02281084 is a clinical study titled "Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes". Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding...
What is the current status of trial NCT02281084?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2015-07-06. Estimated completion is 2023-09-14.
What interventions are being tested in trial NCT02281084?
The interventions under investigation include: Durvalumab (DRUG), Oral Azacitidine (DRUG).
Who is sponsoring clinical trial NCT02281084?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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