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NCT00920140 · ClinicalTrials.gov registry record · Phase 2

Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
97
Enrollment target

NCT00920140: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT00920140 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00920140, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
97 participants
Enrollment target

Study Summary

MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles. This study will identify the maximum tolerated and recommended Phase II doses using a dose-escalation procedure. Dose escalations will continue based on predefined parameters until a maximum tolerated dose is established. In Phase II, the clinical efficacy of GSK1120212 in subjects with relapsed or refractory leukaemias (AML, MDS or CMML) will be determined.

Primary Outcome

An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possib

Interventions

  • DRUG GSK1120212

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2011-05
Est. Completion 2013-04
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT00920140 record still lists

NCT00920140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).

The record links to 0 conditions, and to 1 intervention - of which GSK1120212 is the first listed.

NCT00920140 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00920140 about?

NCT00920140 is a clinical study titled "Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias". MEK111759 is a dose-escalation, Phase I/II, open-label study to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 in subjects with relapsed or refractory leukemias. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, a...

What is the current status of trial NCT00920140?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2011-05. Estimated completion is 2013-04.

What interventions are being tested in trial NCT00920140?

The interventions under investigation include: GSK1120212 (DRUG).

Who is sponsoring clinical trial NCT00920140?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00920140's enrollment target sits among peer trials

97 746th of 2000 higher than 1,254 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00920140, the US trial registry maintained by the National Library of Medicine. NCT00920140 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.