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NCT02223052 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT02223052: Completed Phase 1 study, sponsored by Celgene.
NCT02223052 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02223052, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.
Primary Outcome
The observed maximum concentration
Interventions
- DRUG CC-486
- DRUG Vidaza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2014-10-27 |
| Est. Completion | 2018-12-18 |
| Phase | Phase 1 |
What the finished NCT02223052 record still lists
NCT02223052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 2 interventions - of which CC-486 is the first listed.
NCT02223052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02223052 about?
NCT02223052 is a clinical study titled "Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies". This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subj...
What is the current status of trial NCT02223052?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2014-10-27. Estimated completion is 2018-12-18.
What interventions are being tested in trial NCT02223052?
The interventions under investigation include: CC-486 (DRUG), Vidaza (DRUG).
Who is sponsoring clinical trial NCT02223052?
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 NCT02223052's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 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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