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GW786034 In Patients With Relapsed Or Refractory Soft Tissue Sarcoma
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00297258
  Purpose

The purpose of this study is to evaluate the activity and tolerability of GW786034 in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of GW786034 in this subject population.


Condition Intervention Phase
Sarcoma
Leiomyosarcoma
Adipocytic Tumors
Synovial Sarcoma
Drug: GW786034
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Pazopanib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Progressive free survival [ Time Frame: at 3 months ]

Secondary Outcome Measures:
  • Overall progression free survival, response to treatment, duration of response, overall survival and safety profile [ Time Frame: throughout study ]
  • Response to therapy as defined by the "RECIST" criteria
  • Adverse events recording (graded according to the "Common Terminology Criteria)

Estimated Enrollment: 148
Study Start Date: November 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Histological evidence of high or intermediate grade malignant soft tissue sarcoma, or cytological evidence in case of presence of multiple metastases. List of eligible and ineligible tumours are included in the protocol.
  • Formalin fixed paraffin embedded tumour blocks and representative H/E (haematoxylin/eosin) slides must be available for histological central review. Histological central review is not required before treatment start but is mandatory within 3 months of registration. Local histopathological diagnosis will be accepted for entry into the study.
  • Presence of measurable disease (according to RECIST criteria).
  • Relapsed or refractory disease incurable by surgery or radiotherapy.
  • Evidence of objective progression within the last 6 months (RECIST) documented by measurements of disease,
  • Patients must either not be eligible for chemotherapy (for instance because of age, or because of a biological condition, or because of patient-refusal) or must have received no more than one combination or two single agents chemotherapy regimen for advanced disease; (neo) adjuvant therapy is not counted towards this requirement.
  • At least 18 years of age
  • WHO performance status 0 or 1
  • Adequate bone marrow function
  • Adequate hepatic function
  • Adequate renal function
  • PT / PTT less than 1.2 x UNL.
  • LVEF above the lower limit of normal for the institution, based on ECHO or MUGA
  • Able to swallow and retain oral medication
  • Women should not be of childbearing potential and agree to use contraceptive methods (Oral contraceptives are not allowed).
  • Absence of any serious and/or unstable pre-existing medical, psychiatric or other condition (including lab abnormality) that could interfere with patient safety or obtaining informed consent.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
  • Written informed consent is given according to ICH/GCP, and national/local regulations before patient registration/randomization.

Exclusion Criteria:

  • history of leptomeningeal or brain metastases
  • history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or the patient has been free of any other malignancies for greater than 3 years).
  • Class II, III or IV heart failure (NYHA classification). A patient who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible.
  • Arterial or venous thrombosis, myocardial infarction, unstable angina, cardiac angioplasty or stenting within the last 3 months
  • Uncontrolled or poorly controlled hypertension. Initiation or adjustment of BP medications is permitted prior to study entry, provided that patient has 3 consecutive BP readings less than 150 / 90 mm Hg each separated by a minimum of 24 hrs. These readings need to be collected prior to registration in the study.
  • Women of childbearing potential, who are pregnant (negative serum pregnancy test at entry) or lactating.
  • Therapeutic dose warfarin. Low molecular weight heparin and prophylactic low dose warfarin are permitted. PT/INR and PPT must meet the above inclusion criteria.
  • Concurrent therapy with any specifically prohibited medication or requirement for using any of these medications during treatment with GW786034
  • Major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy, immunotherapy or other investigational agent within the last 28 days and/or not recovered from prior therapy within the last 28 days. Use of erythropoietin is considered supportive care and is permitted. The patient should have recovered from prior surgery and have no open wounds.
  • History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of study drugs. No unresolved bowel obstruction or diarrhea.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297258

Locations
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Leuven, Belgium, 3000
France
GSK Investigational Site
Lyon cedex 03, France, 69437
GSK Investigational Site
Paris Cedex 05, France, 75248
GSK Investigational Site
Villejuif, France, 94805
GSK Investigational Site
Marseille, France, 13385
Hungary
GSK Investigational Site
Budapest, Hungary, 01135
Netherlands
GSK Investigational Site
Rotterdam, Netherlands, 3075 EA
GSK Investigational Site
GRONINGEN, Netherlands, 9713 GZ
GSK Investigational Site
Leiden, Netherlands, 2300 RC
United Kingdom
GSK Investigational Site
Glasgow, United Kingdom, G11 6NT
GSK Investigational Site
London, United Kingdom, SW3 6JJ
GSK Investigational Site
Sheffield, United Kingdom, S10 2SJ
United Kingdom, Lancashire
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M20 4BX
United Kingdom, Northumberland
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: VEG20002, EORTC-62043, EUDRACT-2004-004
Study First Received: February 24, 2006
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00297258  
Health Authority: European Union: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Pazopanib(GW786034)
Sarcoma
Phase II

Study placed in the following topic categories:
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Leiomyosarcoma
Synovial sarcoma
Malignant mesenchymal tumor
Sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 15, 2009