Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01423058 · ClinicalTrials.gov registry record · Phase 1
Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
A Phase 1 study, sponsored by Sierra Oncology LLC - a GSK company.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01423058 is a Phase 1 study that has completed, run by Sierra Oncology LLC - a GSK company. The registered enrollment target is 61 participants.
The verdict
NCT01423058, a Phase 1 study, has completed, sponsored by Sierra Oncology LLC - a GSK company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN share a range of biological, pathological, and clinical features including the relative overproduction of one or more cells of myeloid origin, growth factor independent colony formation in vitro, marrow hypercellularity, extramedullary hematopoiesis, spleno- and hepatomegaly, and thrombotic and/or hemorrhagic diatheses (Tefferi et al., 2005). This is a multi-centre, open-label, non-randomized, dose-escalation study, to be conducted in two phases: a dose-escalation phase (Part 1), to determine the safety and tolerability of momelotinib (CYT387), and to identify a therapeutic dose for the expanded cohort; and a dose-confirmation phase (Part 2), which will be a cohort expansion at or below the MTD of momelotinib. In the Part I dose-escalation phase of the study, subjects will be assigned to dose levels in successive cohorts starting with a dose in the first cohort of 200 mg BID (twice daily with doses taken approximately 12 hours apart). Doses will be escalated by 50 mg BID per cohort until dose-limiting toxicities are observed. The dose level at which ≥2 of 6 subjects develop a first cycle dose-limiting toxicity (DLT) is defined as the DLT level. The maximum tolerated dose (MTD) is defined as the dose level below the DLT level. New dose levels may begin accrual only if all subjects at the current dose level have been observed for a minimum of 28 days from the first day of treatment. The dose level chosen for study in the dose confirmation phase of the study will be the MTD or a lower dose shown to have significant clinical activity (efficacy) as determined by the safety review committee. Subjects will be evaluated weekly for the first cycle, every 2 weeks during cycle 2, then monthly for 4 cycles for
Interventions
- DRUG Momelotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01423058
The ClinicalTrials.gov registry entry for NCT01423058 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sierra Oncology LLC - a GSK company, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Momelotinib is the first listed.
NCT01423058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01423058 about?
NCT01423058 is a clinical study titled "Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis". The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN share a range of biological, ...
What is the current status of trial NCT01423058?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2011-08. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01423058?
The interventions under investigation include: Momelotinib (DRUG).
Who is sponsoring clinical trial NCT01423058?
This trial is sponsored by Sierra Oncology LLC - a GSK company, which has 17 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.