Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02078960
The ClinicalTrials.gov registry entry for NCT02078960 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omacetaxine mepesuccinate is the first listed.
NCT02078960 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.