Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC).

Official Title

A Phase II Study of GW786034 Using a Randomised Discontinuation Design in Subjects With Locally Recurrent or Metastatic Clear-Cell Renal Cell Carcinoma

Conditions

Renal Cell Carcinoma

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • Characterize relationship between the response to GW786034 and the genetic and methylation status of Von Hippel-Lindau (VHL) and other genes related to the growth and progression of renal cell cancer.

Secondary Outcome Measures:

  • Progression-Free Survival
  • Objective Response rate
  • Safety and Tolerability
  • Pharmacokinetics

Study Start

October 2005

Eligibility & Criteria

  • Ages Eligible for Study: 21 Years and above
  • Genders Eligible for Study: Both

Inclusion criteria:

  • Renal Cell Carcinoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Adequate bone marrow function.
  • Adequate renal function.

Exclusion criteria:

  • Have had any major surgery, radiotherapy, or immunotherapy within the last 28 days and/or not recovered from prior therapy.
  • Patients who are pregnant or lactating.
  • Poorly controlled hypertension.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety or obtaining informed consent.

Total Enrolment

230

Contact Details

Australian Locations:

  • GSK Clinical Trials Call Center, South Brisbane, 4101, Australia
  • GSK Clinical Trials Call Center, Camperdown, 2050, Australia
  • GSK Clinical Trials Call Center, Wentworthville, 2145, Australia
  • GSK Clinical Trials Call Center, Footscray, 3011, Australia
  • GSK Clinical Trials Call Center, Heidelberg, 3084, Australia
  • GSK Clinical Trials Call Center, Sydney, 2031, Australia
  • GSK Clinical Trials Call Center, Nedlands, 6009, Australia
  • GSK Clinical Trials Call Center, Kogarah, 2217, Australia
  • GSK Clinical Trials Call Center, Garran Act, 2605, Australia
  • GSK Clinical Trials Call Center, Melbourne, Victoria, 3050, Australia
  • GSK Clinical Trials Call Center, East Melbourne, Victoria, 3002, Australia

For more information, contact Glaxo Smith Kline