Last updated: 11/04/2018 04:40:33

Study to Investigate AKT Inhibitor GSK690693 in Subjects With Relapsed or Refractory Hematologic Malignancies

GSK study ID
AKT108169
Clinicaltrials.gov ID
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: A Phase I Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Potential Anti-cancer Activity of the AKT Inhibitor GSK690693 in Subjects with Relapsed or Refractory Hematologic Malignancies
Trial description: This is a two-part study in subjects with hematologic malignancies designed to find the maximum tolerated dose (MTD) of GSK690693 (Part 1). Part 2 is designed to determine the efficacy of GSK690693 in a subset of subjects with hematologic malignancies.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

To characterize a range of doses and to identify the MTD of GSK690693 when dosed daily for 5 consecutive days every 21 days as an IV infusion over 4 h.

Timeframe: 21 days

Secondary outcomes:

Plasma pharmacokinetic parameters of GSK690693. To evaluate the response of refractory hematologic malignancies to treatment with GSK690693.

Timeframe: 21 days

Blood levels of GSK690693 to derive pharmacokinetic parameters

Timeframe: 21 days

Tumor responses

Timeframe: 21 days

Interventions:
  • Drug: GSK690693
  • Enrollment:
    0
    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)
    November 2008 to March 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Histologically- or cytologically-confirmed diagnosis of a hematologic malignancy that has relapsed or is refractory after standard therapy, AND that is not associated with human immunodeficiency virus (HIV) infection or solid organ transplant.
    • Signed written consent provided.
    • Previously diagnosed diabetes mellitus (type 1 or 2), or gestational diabetes.
    • Symptomatic or untreated central nervous system (CNS) involvement by the hematologic malignancy (including primary CNS lymphoma). Subjects who were previously treated for CNS involvement, and are asymptomatic without anti-epileptic medications or steroids for at least 2 months are eligible.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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

    Additional information
    Not applicable
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