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Sarcoma, Soft TissuePhase 2NCT00297258

Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

A Phase 2 study testing pazopanib in people with Sarcoma, Soft Tissue, run by GlaxoSmithKline at 16 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Sarcoma, Soft Tissue
What is being tested?
pazopanib
Type of treatment
Pill or oral medicine
How many people
148 participants
Where
16 sitesin 5 countries
Study dates
Nov 2005to Feb 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 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.

Trial locations and contacts

16 sites in 5 countries.

16 sites in 5 countries

United Kingdom6 sites

  • GSK Investigational Site

    Glasgow, G11 6NT

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    Manchester, Lancashire, M20 4BX

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    Sheffield, S10 2SJ

Other trials in United Kingdom

France4 sites

  • GSK Investigational Site

    Lyon, 69437

  • GSK Investigational Site

    Marseille, 13385

  • GSK Investigational Site

    Paris, 75248

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Netherlands3 sites

  • GSK Investigational Site

    Groningen, 9713 GZ

  • GSK Investigational Site

    Leiden, 2300 RC

  • GSK Investigational Site

    Rotterdam, 3075 EA

Other trials in Netherlands

Belgium2 sites

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Leuven, 3000

Other trials in Belgium

Hungary1 site

  • GSK Investigational Site

    Budapest, 01135

Other trials in Hungary

About this study

Official title: Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma

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.

Being tested
pazopanib
Keywords
Sarcoma, Synovial sarcoma, Pazopanib(GW786034), Adipocytic tumors, Leiomyosarcoma, Phase II
Medical subject headings
Sarcoma, Sarcoma, Synovial, Leiomyosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pazopanibDrug

    Also called GW786034

    oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (3)

  1. Overall Survival

    Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.

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

  2. Progression Free Survival

    Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.

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

  3. Overall Response

    Overall response is the number of participants who had a best outcome of 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) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a >=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297258
Sponsor's protocol ID
VEG20002
Status last verified
Dec 2015
First submitted
24 Feb 2006
Last updated
3 Feb 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 19451427

  • 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.

    PubMed 22805326

  • 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.

    PubMed 24504442

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib in people with Sarcoma, Soft Tissue, run by GlaxoSmithKline at 16 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom, France, Netherlands, Belgium, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00297258, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.

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