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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumor, Lymphoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

given weekly or twice weekly over 1 - 4 hours

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

AKT106757

NCT ID:

NCT00493818

Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

  • Tumor
  • Lymphoma
  • Solid Tumors,
  • Lymphoma,
  • GSK690693,
  • AKT
  • Lymphoma

Name

Location

GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteRoyal Oak, Michigan  48073