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NCT02078960 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)
A Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02078960: Clinical Trial Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02078960 is a Phase 1 study that was terminated before completion, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02078960, a Phase 1 study, was terminated before completion, sponsored by Teva Branded Pharmaceutical Products R&D.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase 1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary safety and efficacy of omacetaxine following a fixed-dose administration to patients with CP or AP CML who have failed 2 or more tyrosine kinase inhibitor (TKI) therapies.
Primary Outcome
The Independent Data Monitoring Committee assessments are summarized. Major response for participants with chronic phase CML was a major cytogenetic response (MCyR) defined as a complete cytogenetic response with no Ph+ metaphases, or a partial cytogenetic response with up to 35% Ph+ metaphases. Note that a complete hematologic response was not considered a major response. Major response for participants with accelerated phase CML was a major hematologic response (MaHR) defined as a complete he
Interventions
- DRUG Omacetaxine mepesuccinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-10-09 |
| Est. Completion | 2017-11-27 |
| Phase | Phase 1 |
Why NCT02078960 stopped before completion
NCT02078960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Omacetaxine mepesuccinate is the first listed.
NCT02078960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02078960 about?
NCT02078960 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)". To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase 1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary safety and efficacy of omacetaxine following a fixed-dose administration to patients with CP or AP CML who have failed 2...
What is the current status of trial NCT02078960?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-10-09. Estimated completion is 2017-11-27.
What interventions are being tested in trial NCT02078960?
The interventions under investigation include: Omacetaxine mepesuccinate (DRUG).
Who is sponsoring clinical trial NCT02078960?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02078960's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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