GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma

This study is ongoing, but not recruiting participants.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00244764

Purpose

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).

Condition	Intervention	Phase
Renal Cell Carcinoma Solid Tumor Cancer	Drug: GW786034	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Pazopanib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment:	230
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244764

Show 44 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	VEG102616
Study First Received:	October 25, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00244764
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; United Kingdom: National Health Service

Keywords provided by GlaxoSmithKline:

Renal Cell Carcinoma
Angiogenesis
Solid tumors
Pazopanib(GW786034)

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases

Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Clear cell renal cell carcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009