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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00493818

Enrollment

Registered

2007-06-28

Start date

2007-04-30

Completion date

2008-06-30

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

GSK690693,, Solid Tumors,, Lymphoma,, AKT

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.

Interventions

DRUGGSK690693

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026