NCT00297258

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_2

Geographic Reach
5 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 6, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 3, 2016

Status Verified

December 1, 2015

Enrollment Period

8.3 years

First QC Date

February 24, 2006

Results QC Date

December 2, 2009

Last Update Submit

January 4, 2016

Conditions

Sarcoma, Soft Tissue

Keywords

SarcomaSynovial sarcomaPazopanib(GW786034)Adipocytic tumorsLeiomyosarcomaPhase II

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival at Week 12

    Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a \>=20% increase in target lesions.

    Week 12

Secondary Outcomes (3)

  • Overall Survival

    Start of therapy until death (up to approximately 5 years)

  • Progression Free Survival

    Start of therapy until progression (up to approximately 5 years)

  • Overall Response

    Baseline until either response or progression (up to approximately 5 years)

Interventions

pazopanibDRUG

oral tablet

Also known as: GW786034

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • +3 more criteria

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Lyon, 69437, France

Location

GSK Investigational Site

Marseille, 13385, France

Location

GSK Investigational Site

Paris, 75248, France

Location

GSK Investigational Site

Villejuif, 94805, France

Location

GSK Investigational Site

Budapest, 01135, Hungary

Location

GSK Investigational Site

Groningen, 9713 GZ, Netherlands

Location

GSK Investigational Site

Leiden, 2300 RC, Netherlands

Location

GSK Investigational Site

Rotterdam, 3075 EA, Netherlands

Location

GSK Investigational Site

Manchester, Lancashire, M20 4BX, United Kingdom

Location

GSK Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

GSK Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

GSK Investigational Site

London, SW3 6JJ, United Kingdom

Location

GSK Investigational Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 19451427BACKGROUND

  • 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.

    PMID: 22805326BACKGROUND

  • 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: 24504442DERIVED

MeSH Terms

Conditions

SarcomaSarcoma, SynovialLeiomyosarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueNeoplasms, Muscle Tissue

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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 28, 2006

Study Start

November 1, 2005

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 3, 2016

Results First Posted

January 6, 2010

Record last verified: 2015-12

Locations

BE(2)FR(4)HU(1)NL(3)GB(6)