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NCT00880321 · ClinicalTrials.gov registry record · Phase 1

A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors

A Phase 1 study of Cancer, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
170
Enrollment target
8
Study locations

NCT00880321 is a Phase 1 study of Cancer that has completed, run by GlaxoSmithKline. The registered enrollment target is 170 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (95% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT00880321, a Phase 1 study of Cancer, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
170 participants
Enrollment target
8
Study locations

Study Summary

BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of the orally administered GSK2118436. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of subjects with solid tumors. This is a two-part study. Part 1 will identify the recommended Part 2 dose using a dose-escalation procedure. Escalation may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached. The recommended Part 2 dose will be expanded to up to 12 patients. Part 2 will explore further the safety, tolerability, and clinical activity of GSK2118436 in subjects with BRAF mutation-positive tumors. In addition, the effect of GSK2118436 on midazolam will be assessed in a subset of patients in Part 2. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2.

Conditions Studied

Cancer

Interventions

  • DRUG Midazolam
  • DRUG GSK2118436

Study Locations (8)

New South Wales

  • GSK Investigational Site - Randwick
  • GSK Investigational Site - Westmead

California

  • GSK Investigational Site - Los Angeles

New York

  • GSK Investigational Site - New York

Tennessee

  • GSK Investigational Site - Nashville

Texas

  • GSK Investigational Site - Houston

South Australia

  • GSK Investigational Site - Adelaide

Western Australia

  • GSK Investigational Site - Nedlands

Trial Details

FieldValue
Enrollment Target 170 participants
Start Date 2009-06-04
Est. Completion 2012-03-20
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00880321

The ClinicalTrials.gov registry entry for NCT00880321 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 170 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 (95% 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 2 interventions - of which Midazolam is the first listed.

NCT00880321 reports 8 study locations spanning 7 distinct geographic areas - top geographies include New South Wales, California, New York.

Frequently Asked Questions

What is clinical trial NCT00880321 about?

NCT00880321 is a clinical study titled "A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors". BRF112680 is a first-time-in-human study to establish the recommended dose and schedule of the orally administered GSK2118436. The recommended dose and regimen will be selected based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after the treatment of subjects with solid tumo...

What is the current status of trial NCT00880321?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2009-06-04. Estimated completion is 2012-03-20.

What conditions does trial NCT00880321 study?

This clinical trial studies the following conditions: Cancer.

What interventions are being tested in trial NCT00880321?

The interventions under investigation include: Midazolam (DRUG), GSK2118436 (DRUG).

Who is sponsoring clinical trial NCT00880321?

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

Where is trial NCT00880321 being conducted?

This trial has 8 study locations across California, New York, Tennessee, Texas, New South Wales. 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.