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NCT02117219 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT02117219: Completed Phase 1 study, sponsored by MedImmune.
NCT02117219 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117219, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents
Primary Outcome
DLT (MEDI4736 monotherapy only) assessment will be done by reviewing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. For monotherapy or combo w/aza AEs, SAEs, lab evaluations, vital signs, physical exams, ECGs will be done.
Interventions
- BIOLOGICAL tremelimumab
- BIOLOGICAL MEDI4736 Evaluate MEDI4736 in MDS
- DRUG VIDAZA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2014-05-20 |
| Est. Completion | 2019-04-30 |
| Phase | Phase 1 |
What the finished NCT02117219 record still lists
NCT02117219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 3 interventions - of which tremelimumab is the first listed.
NCT02117219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02117219 about?
NCT02117219 is a clinical study titled "Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome". This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents
What is the current status of trial NCT02117219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2014-05-20. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT02117219?
The interventions under investigation include: tremelimumab (BIOLOGICAL), MEDI4736 Evaluate MEDI4736 in MDS (BIOLOGICAL), VIDAZA (DRUG).
Who is sponsoring clinical trial NCT02117219?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02117219's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 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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