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

This study has been terminated.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00493818
First received: June 27, 2007
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Tumor
Lymphoma
Drug: GSK690693
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 70
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK690693
    Other Name: GSK690693
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493818

Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00493818     History of Changes
Other Study ID Numbers: AKT106757
Study First Received: June 27, 2007
Last Updated: October 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Solid Tumors,
Lymphoma,
GSK690693,
AKT

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014