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

Phase 1

Terminated

• Conditions: Cancer

• Registration Number: NCT00493818
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-28
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.	given weekly or twice weekly over 1 - 4 hours

Secondary Outcome Measures

Name	Time	Method
12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs	4, 8, 10, 12, 14, 24hrs
Urinalysis samples while the patient is hospitalized	while the patient is hospitalized
Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.	draws before, during, and after the infusion
Blood pressure and heart rate every 8 hours.	every 8 hours.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Durham, North Carolina, United States