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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: Completed Phase 1 study of Cancer, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2009-06-04 |
| Est. Completion | 2012-03-20 |
| Phase | Phase 1 |
What the finished NCT00880321 record still lists
NCT00880321 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (95% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT00880321's enrollment target sits among peer trials
170 252nd of 615 higher than 362 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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.
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