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NCT01138085 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics (PK) of AKT and MEK Combination
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 240
- Enrollment target
NCT01138085 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 240 participants.
The verdict
NCT01138085, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 240 participants
- Enrollment target
Study Summary
This study is a Phase 1 dose-escalation open-label study to determine the recommended Phase II dose (RP2D) and regimen for the combination of the orally administered MEK inhibitor GSK1120212 and the orally administered AKT kinase inhibitor GSK2141795. The study consists of two parts. Part 1A will identify the maximum tolerated dose (MTD) using a Zone-Based, modified 3 plus 3 dose escalation procedure. The starting dose (Zone 1, Cohort 1) will be 0.5mg GSK1120212 combined with 25mg GSK2141795. Dose escalation will continue based on predefined parameters until a MTD is established. The initial regimen for dose escalation in Part 1A will be continuous oral daily dosing. Once the continuous daily dosing MTD or RP2D has been established in Part 1A, Part 1B will explore alternate dosing schedule(s) in which the dosing schedule may be adjusted for either GSK1120212 or GSK2141795. Dose escalation will proceed using a 3 plus 3 dose escalation procedure until an MTD or RP2D of that alternate schedule is defined. Part 2 will explore further in specific tumor types the safety, tolerability, clinical activity, pharmacokinetic (PK) and pharmacodynamic (PD) properties of the combination of GSK1120212 and GSK2141795 at the recommended dose(s) and regimen(s) identified in Part 1.
Interventions
- DRUG GSK1120212
- DRUG GSK2141795
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2010-05-04 |
| Est. Completion | 2014-11-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01138085
The ClinicalTrials.gov registry entry for NCT01138085 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK1120212 is the first listed.
NCT01138085 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01138085 about?
NCT01138085 is a clinical study titled "Safety, Pharmacokinetics (PK) of AKT and MEK Combination". This study is a Phase 1 dose-escalation open-label study to determine the recommended Phase II dose (RP2D) and regimen for the combination of the orally administered MEK inhibitor GSK1120212 and the orally administered AKT kinase inhibitor GSK2141795. The study consists of two parts. Part 1A will id...
What is the current status of trial NCT01138085?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2010-05-04. Estimated completion is 2014-11-19.
What interventions are being tested in trial NCT01138085?
The interventions under investigation include: GSK1120212 (DRUG), GSK2141795 (DRUG).
Who is sponsoring clinical trial NCT01138085?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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