An Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the AKT Inhibitor GSK690693 Given on Various Schedules in Subjects With Solid Tumors or Lymphoma

GlaxoSmithKline1 site in 1 country70 target enrollmentApril 2007

ConditionsCancer

DrugsGSK690693

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cancer
Sponsor: GlaxoSmithKline
Enrollment: 70
Locations: 1
Primary Endpoint: To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

June 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: given weekly or twice weekly over 1 - 4 hours

Secondary Outcomes

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.)