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NCT02177812 · ClinicalTrials.gov registry record · Phase 1
A Phase I Dose Escalation Study of GSK2879552 in Subjects With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT02177812 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 41 participants.
The verdict
NCT02177812, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) and regimen for the orally administered lysine specific demethylase 1 (LSD1) inhibitor GSK2879552, alone or in combination with All-Trans Retinoic Acid (ATRA). The recommended dose and regimen will be selected based on the safety, pharmacokinetic (PK), and pharmacodynamic (PD) profiles observed after the treatment of subjects with relapsed/refractory AML. The study consists of two parts. Part 1 will identify the maximum tolerated dose (MTD) and/or RP2D using a dose-escalation procedure. Dose escalations will be guided by the Neuenschwander-continual reassessment method (N-CRM). PK/PD expansion cohorts will also be included in Part 1 to characterize the range of biologically effective doses by assessing PD markers and obtain additional PK data. Part 2 will explore further the safety, tolerability, and clinical activity of GSK2879552, alone or in combination with ATRA, at the RP2D in subjects with AML.
Interventions
- DRUG ATRA
- DRUG GSK2879552
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2014-08-27 |
| Est. Completion | 2017-12-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02177812
The ClinicalTrials.gov registry entry for NCT02177812 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ATRA is the first listed.
NCT02177812 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02177812 about?
NCT02177812 is a clinical study titled "A Phase I Dose Escalation Study of GSK2879552 in Subjects With Acute Myeloid Leukemia (AML)". This study is a phase I, open-label study to determine recommended phase 2 dose (RP2D) and regimen for the orally administered lysine specific demethylase 1 (LSD1) inhibitor GSK2879552, alone or in combination with All-Trans Retinoic Acid (ATRA). The recommended dose and regimen will be selected bas...
What is the current status of trial NCT02177812?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2014-08-27. Estimated completion is 2017-12-08.
What interventions are being tested in trial NCT02177812?
The interventions under investigation include: ATRA (DRUG), GSK2879552 (DRUG).
Who is sponsoring clinical trial NCT02177812?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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