Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693

Stopped early · Phase 1

Conditions studied: Cancer

In brief

This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.

Key facts

Study ID

NCT00493818

Run by

GlaxoSmithKline

People needed

70

Starts

2007-04-01

Expected to finish

2008-06-01

Last updated by the study team

2017-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved therapy
• Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

You may not qualify if…

• Prior anti-cancer therapy within the prior 28 days.
• History of diabetes.
• Coronary artery disease/myocardial infarction, acute coronary syndromes within the past 6 months.
• Use of theophylline and warfarin within 14 days prior to the first dose of study drug.
• Current use of oral corticosteroids (note: Inhaled corticosteroids are permitted.)
• Participation in an investigational study within the prior 28 days.
• Pregnant or breast-feeding.

Where it is running

• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Detroit, Michigan, United States
• GSK Investigational Site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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