Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
NCT ID: NCT00753688
Last Updated: 2013-08-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
369 participants
INTERVENTIONAL
2008-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PLACEBO
matching placebo 800 mg once daily orally
Placebo
matching placebo 800 mg once daily orally
PAZOPANIB
800 mg once daily orally
PAZOPANIB
800 mg once daily orally
Interventions
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PAZOPANIB
800 mg once daily orally
Placebo
matching placebo 800 mg once daily orally
Eligibility Criteria
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Exclusion Criteria
* Metastatic and measurable disease (RECIST);
* Subjects can have received maximum of 4 prior lines of systemic therapies (including up to 2 combination regimens) for advanced disease. (Neo) adjuvant/maintenance treatments are not counted for this criterion;
* Last dose of prior therapy can be given upto 14 days prior to start of study if all ongoing toxicity from prior anticancer therapy are grade 1 or resolved (except alopecia).
* Must have failed anthracycline-based therapy and available standard chemotherapies at the treating institution except if medically contraindicated or refused by patient;
* No treatment with anti-angiogenesis inhibitors;
* Age \> 18 years
* WHO PS 0-1;
* No leptomeningeal or brain metastases, normal bone marrow, liver, renal and cardiac functions;
* No prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix or breast or the patient has been free of any other malignancies for \> 3 years)
* Adequate bone marrow function; adequate blood clotting results; adequate hepatic and renal function;
* No poorly controlled hypertension;
* Clinically normal cardiac function;
* No clinically significant gastrointestinal abnormalities including malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
* No cerebrovascular accidents 1
* No transient ischemic attack, deep vein thrombosis or pulmonary embolism within past six months;
* No active bleeding or bleeding diathesis;
* No hemoptysis within six weeks of study drug;
* No major surgery or trauma within 28 days of therapy treatment;
* Concomitant medication restriction;
* No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
* Ability to swallow \& retain oral medication
* Adequate contraception must be used;
* No 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 randomization in the trial.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Los Angeles, California, United States
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Orange, California, United States
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Santa Monica, California, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Clevand, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Randwick, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Kurralta Park, South Australia, Australia
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Hobart, Tasmania, Australia
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Box Hill, Victoria, Australia
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Nedlands, Western Australia, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Herlev, , Denmark
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Bordeaux, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Paris, , France
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Saint-Priest-en-Jarez, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Heidelberg, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Bad Saarow, Brandenburg, Germany
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Frankfurt am Main, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Napoli, Campania, Italy
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Rome, Lazio, Italy
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Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Rozzano (MI), Lombardy, Italy
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Candiolo (TO), Piedmont, Italy
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Turin, Piedmont, Italy
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Terni, Umbria, Italy
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Aichi, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Hokkaido, , Japan
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Mie, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Tokyo, , Japan
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Daegu, , South Korea
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Goyang-si, Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Madrid, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Manchester, Lancashire, United Kingdom
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Glasgow, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
Countries
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References
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van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16.
Cesne AL, Bauer S, Demetri GD, Han G, Dezzani L, Ahmad Q, Blay JY, Judson I, Schoffski P, Aglietta M, Hohenberger P, Gelderblom H. Safety and efficacy of Pazopanib in advanced soft tissue sarcoma: PALETTE (EORTC 62072) subgroup analyses. BMC Cancer. 2019 Aug 13;19(1):794. doi: 10.1186/s12885-019-5988-3.
Kawai A, Araki N, Hiraga H, Sugiura H, Matsumine A, Ozaki T, Ueda T, Ishii T, Esaki T, Machida M, Fukasawa N. A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup. Jpn J Clin Oncol. 2016 Mar;46(3):248-53. doi: 10.1093/jjco/hyv184. Epub 2016 Feb 10.
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.
Other Identifiers
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VEG110727
Identifier Type: -
Identifier Source: org_study_id
NCT00794521
Identifier Type: -
Identifier Source: nct_alias