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

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 1

Conditions

Cancer

Treatments

Drug: GSK690693

Study type

Interventional

Funder types

Industry

Identifiers

NCT00493818

AKT106757

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.