Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212
Completed · Phase 2
Conditions studied: Cancer
In brief
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.
Key facts
- Study ID
- NCT01072175
- Run by
- Novartis Pharmaceuticals
- People needed
- 430
- Starts
- 2010-03-26
- Expected to finish
- 2018-02-27
- Last updated by the study team
- 2019-07-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Los Angeles, California, United States
- Novartis Investigative Site — San Francisco, California, United States
- Novartis Investigative Site — Aurora, Colorado, United States
- Novartis Investigative Site — New Haven, Connecticut, United States
- Novartis Investigative Site — Tampa, Florida, United States
- Novartis Investigative Site — Lutherville-Timonium, Maryland, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Rochester, Minnesota, United States
- Novartis Investigative Site — Philadelphia, Pennsylvania, United States
- Novartis Investigative Site — Nashville, Tennessee, United States
- Novartis Investigative Site — Nashville, Tennessee, United States
- Novartis Investigative Site — Houston, Texas, United States
- Novartis Investigative Site — Westmead, New South Wales, Australia
- Novartis Investigative Site — Heidelberg, Victoria, Australia
Full record on ClinicalTrials.gov
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