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NCT01340833 · ClinicalTrials.gov registry record · Phase 1

Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microtracer of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

A Phase 1 study of Cancer, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target
1
Study location

NCT01340833 is a Phase 1 study of Cancer that has completed, run by GlaxoSmithKline. The registered enrollment target is 6 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01340833, a Phase 1 study of Cancer, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is currently being developed for the treatment of BRAF mutation-positive tumors. This is an open-label, non-randomized study designed to determine the absolute bioavailability of an oral dose of 150 mg of GSK2118436 co-administered with an intravenous 50 microgram dose of \[14C\]GSK2118436 in subjects with BRAF mutant solid tumors. Pharmacokinetic samples will be obtained up to 72 hours post-dose. Safety assessments will be performed throughout the study. After completing all assessments, eligible subjects may transition to BRF114144, an open-label, rollover study of GSK2118436 to continue treatment.

Conditions Studied

Interventions

  • DRUG GSK2118436

Study Locations (1)

Washington

  • GSK Investigational Site - Tacoma

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2011-06-08
Est. Completion 2011-09-12
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01340833

The ClinicalTrials.gov registry entry for NCT01340833 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which GSK2118436 is the first listed.

NCT01340833 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT01340833 about?

NCT01340833 is a clinical study titled "Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microtracer of GSK2118436 in Subjects With BRAF Mutant Solid Tumors". GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is currently being developed for the treatment of BRAF mutation-positive tumors. This is an open-label, non-randomized study designed to determine the absolute bioavailability of an oral dose of 150 mg of G...

What is the current status of trial NCT01340833?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-06-08. Estimated completion is 2011-09-12.

What conditions does trial NCT01340833 study?

This clinical trial studies the following conditions: Cancer.

What interventions are being tested in trial NCT01340833?

The interventions under investigation include: GSK2118436 (DRUG).

Who is sponsoring clinical trial NCT01340833?

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

Where is trial NCT01340833 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.