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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: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.

NCT01248858 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
GlaxoSmithKline

1,345 total trials

Why NCT01248858 stopped before completion

NCT01248858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).

The record links to 0 conditions, and to 1 intervention - of which GSK2126458 and GSK1120212 is the first listed.

NCT01248858 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01248858's enrollment target sits among peer trials

69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01248858, the US trial registry maintained by the National Library of Medicine. NCT01248858 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.