Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy

NCT00753688 | Completed Phase 3 Results DMC

• 1 other identifier: VEG110727
• Study Type: interventional
• Target: 369
• Locations: 13 countries
• Sites: 81

Brief Summary

A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy

Conditions

Sarcoma, Soft Tissue

Keywords

metastatic soft-tissue sarcoma; pazopanib; Soft Tissue Sarcoma; placebo

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.

  From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)

Secondary Outcomes (10)

• Overall Survival (OS)

  From the date of randomization until 215 deaths (assessed for an average of 12 months)

• Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator

  From the start of treatment until disease progression (assessed for an average of 10 months)

• Time to Response Assessed by an Independent Radiologist and the Investigator

  From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)

• Duration of Response Assessed by the Independent Radiologist and the Investigator

  From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)

• PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)

  From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

matching placebo 800 mg once daily orally

Drug: Placebo

PAZOPANIB

EXPERIMENTAL

800 mg once daily orally

Drug: PAZOPANIB

Interventions

PAZOPANIB DRUG

800 mg once daily orally

PAZOPANIB

Placebo DRUG

matching placebo 800 mg once daily orally

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• High or intermediate grade of soft tissue sarcoma; Low grade tumours allowed provided there is disease progression.
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (81)

GSK Investigational Site

Birmingham, Alabama, 35243, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Orange, California, 92868, United States

Location

GSK Investigational Site

Santa Monica, California, 90403, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

GSK Investigational Site

Clevand, Ohio, 44106, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19106, United States

Location

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

GSK Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

GSK Investigational Site

Kurralta Park, South Australia, 5037, Australia

Location

GSK Investigational Site

Hobart, Tasmania, 7000, Australia

Location

GSK Investigational Site

Box Hill, Victoria, 3128, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Herlev, DK-2730, Denmark

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

GSK Investigational Site

Lille, 59020, France

Location

GSK Investigational Site

Lyon, 69373, France

Location

GSK Investigational Site

Marseille, 13385, France

Location

GSK Investigational Site

Paris, 75248, France

Location

GSK Investigational Site

Saint-Priest-en-Jarez, 42271, France

Location

GSK Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

GSK Investigational Site

Villejuif, 94805, France

Location

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

GSK Investigational Site

Bad Saarow, Brandenburg, 15526, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45122, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Napoli, Campania, 80131, Italy

Location

GSK Investigational Site

Rome, Lazio, 00144, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20133, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20162, Italy

Location

GSK Investigational Site

Rozzano (MI), Lombardy, 20089, Italy

Location

GSK Investigational Site

Candiolo (TO), Piedmont, 10060, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10153, Italy

Location

GSK Investigational Site

Terni, Umbria, 05100, Italy

Location

GSK Investigational Site

Aichi, 464-8681, Japan

Location

GSK Investigational Site

Chiba, 260-8717, Japan

Location

GSK Investigational Site

Fukuoka, 811-1395, Japan

Location

GSK Investigational Site

Hokkaido, 003-0804, Japan

Location

GSK Investigational Site

Mie, 514-8507, Japan

Location

GSK Investigational Site

Okayama, 700-8558, Japan

Location

GSK Investigational Site

Osaka, 537-8511, Japan

Location

GSK Investigational Site

Osaka, 540-0006, Japan

Location

GSK Investigational Site

Tokyo, 104-0045, Japan

Location

GSK Investigational Site

Amsterdam, 1066 CX, Netherlands

Location

GSK Investigational Site

Groningen, 9713 GZ, Netherlands

Location

GSK Investigational Site

Leiden, 2300 RC, Netherlands

Location

GSK Investigational Site

Nijmegen, 6525 GA, Netherlands

Location

GSK Investigational Site

Rotterdam, 3075 EA, Netherlands

Location

GSK Investigational Site

Daegu, 705-717, South Korea

Location

GSK Investigational Site

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 135-710, South Korea

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GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Palma de Mallorca, 07010, Spain

Location

GSK Investigational Site

Valencia, 46009, Spain

Location

GSK Investigational Site

Gothenburg, SE413 45, Sweden

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GSK Investigational Site

Linköping, SE-581 85, Sweden

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GSK Investigational Site

Lund, SE-221 85, Sweden

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GSK Investigational Site

Umeå, SE-901 85, Sweden

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

Location

GSK Investigational Site

Manchester, Lancashire, M20 4BX, United Kingdom

Location

GSK Investigational Site

Glasgow, G12 0YN, United Kingdom

Location

GSK Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

GSK Investigational Site

London, SW3 6JJ, United Kingdom

Location

GSK Investigational Site

Nottingham, NG5 1PB, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 22595799 BACKGROUND

• 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.

  PMID: 31409302 DERIVED

• 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.

  PMID: 26864131 DERIVED

• 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.

  PMID: 24504442 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 16, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2012
• Last Updated: August 22, 2013
• Results First Posted: December 21, 2011

Record last verified: 2013-08

Locations

AU (6); DE (8); KR (6); GB (6); NL (5); US (10); IT (8); DK (1); SE (5); JP (9); BE (5); FR (8); ES (4)