Last updated: 11/04/2018 04:40:26

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

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GSK study ID
AKT106757
See study documents
Clinicaltrials.gov ID
NCT00493818
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: given weekly or twice weekly over 1 - 4 hours

Secondary outcomes:

Blood pressure and heart rate every 8 hours.

Timeframe: every 8 hours.

12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs

Timeframe: 4, 8, 10, 12, 14, 24hrs

Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.

Timeframe: draws before, during, and after the infusion

Urinalysis samples while the patient is hospitalized

Timeframe: while the patient is hospitalized

Interventions:
  • Drug: GSK690693
    • Enrollment:
    70
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cancer
    Product
    GSK690693
    Collaborators
    Not applicable
    Study date(s)
    April 2007 to June 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • Prior anti-cancer therapy within the prior 28 days.
    • History of diabetes.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27710
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48201
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46202
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-08-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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