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NCT01072175 · ClinicalTrials.gov registry record · Phase 2
Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 430
- Enrollment target
NCT01072175: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01072175 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 430 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (223% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01072175, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 430 participants
- Enrollment target
Study Summary
This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436 was investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose combinations was identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 were evaluated, based on results from the dose escalation cohorts. In Part D, the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in combination with GSK1120212 was evaluated.
Primary Outcome
Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.
Interventions
- DRUG GSK2118436
- DRUG GSK1120212
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2010-03-26 |
| Est. Completion | 2018-02-27 |
| Phase | Phase 2 |
What the finished NCT01072175 record still lists
NCT01072175 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (223% higher).
The record links to 0 conditions, and to 2 interventions - of which GSK2118436 is the first listed.
NCT01072175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01072175 about?
NCT01072175 is a clinical study titled "Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212". This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single ...
What is the current status of trial NCT01072175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 430 participants. The study started on 2010-03-26. Estimated completion is 2018-02-27.
What interventions are being tested in trial NCT01072175?
The interventions under investigation include: GSK2118436 (DRUG), GSK1120212 (DRUG).
Who is sponsoring clinical trial NCT01072175?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01072175's enrollment target sits among peer trials
430 90th of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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