Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Celgene.
NCT02281084 is a Phase 2 study that has completed, run by Celgene. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The overall response rate (ORR) was defined as the percentage of participants who achieved an objective response including: hematologic improvement (HI), partial remission (PR), complete remission (CR), or marrow complete remission (mCR). Hematologic response was defined as: • CR: ≤ 5% myeloblasts with normal maturation of all cell lines; peripheral blood (PB) shows: hemoglobin ≥11 g/dL, neutrophils ≥1.0x10\^9/L, platelets ≥100x10\^9/dL, blasts (0%) • PR: same as CR bone marrow (BM) shows blasts
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 |
What the finished NCT02281084 record still lists
NCT02281084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT02281084 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02281084's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03366116 · 65 participants · Phase 1
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
- NCT03603730 · 65 participants · NA
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
- NCT03796559 · 65 participants · NA
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
- NCT03993106 · 65 participants · Phase 2
A Study of sEphB4-HSA in Kaposi Sarcoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI