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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 89 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02223052
The ClinicalTrials.gov registry entry for NCT02223052 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 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 CC-486 is the first listed.
NCT02223052 reports 0 study locations.
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.
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