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NCT01248858 · ClinicalTrials.gov registry record · Phase 1

Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.

A Phase 1 study, sponsored by GlaxoSmithKline.

Terminated
Registry status
Phase 1
Development phase
69
Enrollment target

NCT01248858 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 69 participants.

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The verdict

NCT01248858, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.

TERMINATED
Registry status
Phase 1
Development phase
69 participants
Enrollment target

Study Summary

This is a Phase I, open-label, dose-escalation study to characterize the safety, tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in subjects with advanced solid tumors. The study will be conducted in 2 parts, a dose escalation phase and a tumor specific cohort expansion.

Interventions

  • DRUG GSK2126458 and GSK1120212

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2010-12-03
Est. Completion 2015-04-23
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01248858

The ClinicalTrials.gov registry entry for NCT01248858 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 69 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 1 intervention - of which GSK2126458 and GSK1120212 is the first listed.

NCT01248858 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01248858 about?

NCT01248858 is a clinical study titled "Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK2126458 and GSK1120212 Combination Therapy in Subjects With Advanced Solid Tumors.". This is a Phase I, open-label, dose-escalation study to characterize the safety, tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in subjects with advanced solid tumo...

What is the current status of trial NCT01248858?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2010-12-03. Estimated completion is 2015-04-23.

What interventions are being tested in trial NCT01248858?

The interventions under investigation include: GSK2126458 and GSK1120212 (DRUG).

Who is sponsoring clinical trial NCT01248858?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.