Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

NCT ID: NCT00297258

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of this study is to evaluate the activity and tolerability of pazopanib 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 pazopanib in this subject population.

Conditions

Sarcoma, Soft Tissue

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pazopanib

oral tablet

Intervention Type: DRUG

Other Intervention Names

GW786034

Eligibility 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.

• Concurrent therapy with any specifically prohibited medication or requirement for using any of these medications during treatment with pazopanib
• 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.

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Lyon, , France

GSK Investigational Site

Marseille, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Villejuif, , France

GSK Investigational Site

Budapest, , Hungary

GSK Investigational Site

Groningen, , Netherlands

GSK Investigational Site

Leiden, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Manchester, Lancashire, United Kingdom

GSK Investigational Site

Glasgow, , United Kingdom

GSK Investigational Site

Leeds, , United Kingdom

GSK Investigational Site

London, , United Kingdom

GSK Investigational Site

Newcastle upon Tyne, , United Kingdom

GSK Investigational Site

Sheffield, , United Kingdom

Countries

Belgium; France; Hungary; Netherlands; United Kingdom

References

Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schoffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

Reference Type: BACKGROUND

PMID: 19451427 (View on PubMed)

Sleijfer S, Gorlia T, Lamers C, Burger H, Blay JY, Le Cesne A, Scurr M, Collin F, Pandite L, Marreaud S, Hohenberger P. Cytokine and angiogenic factors associated with efficacy and toxicity of pazopanib in advanced soft-tissue sarcoma: an EORTC-STBSG study. Br J Cancer. 2012 Aug 7;107(4):639-45. doi: 10.1038/bjc.2012.328. Epub 2012 Jul 17.

Reference Type: BACKGROUND

PMID: 22805326 (View on PubMed)

Kasper B, Sleijfer S, Litiere S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.

Reference Type: DERIVED

PMID: 24504442 (View on PubMed)

Other Identifiers

VEG20002

Identifier Type: -

Identifier Source: org_study_id

NCT00293449

Identifier Type: -

Identifier Source: nct_alias