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Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

4. januar 2016 opdateret af: GlaxoSmithKline

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.

Studieoversigt

Status

Afsluttet

Betingelser

Sarkom, blødt væv

Intervention / Behandling

Medicin: pazopanib

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

148

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Belgien
- - Bruxelles, Belgien, 1000
    - GSK Investigational Site
  - Leuven, Belgien, 3000
    - GSK Investigational Site
Det Forenede Kongerige
- - Glasgow, Det Forenede Kongerige, G11 6NT
    - GSK Investigational Site
  - Leeds, Det Forenede Kongerige, LS9 7TF
    - GSK Investigational Site
  - London, Det Forenede Kongerige, SW3 6JJ
    - GSK Investigational Site
  - Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
    - GSK Investigational Site
  - Sheffield, Det Forenede Kongerige, S10 2SJ
    - GSK Investigational Site
- Lancashire
  - Manchester, Lancashire, Det Forenede Kongerige, M20 4BX
    - GSK Investigational Site
Frankrig
- - Lyon cedex 03, Frankrig, 69437
    - GSK Investigational Site
  - Marseille, Frankrig, 13385
    - GSK Investigational Site
  - Paris Cedex 05, Frankrig, 75248
    - GSK Investigational Site
  - Villejuif, Frankrig, 94805
    - GSK Investigational Site
Holland
- - Groningen, Holland, 9713 GZ
    - GSK Investigational Site
  - Leiden, Holland, 2300 RC
    - GSK Investigational Site
  - Rotterdam, Holland, 3075 EA
    - GSK Investigational Site
Ungarn
- - Budapest, Ungarn, 01135
    - GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

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.
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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Progression Free Survival at Week 12 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Overall Survival Tidsramme: Start of therapy until death (up to approximately 5 years)	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.	Start of therapy until death (up to approximately 5 years)
Progression Free Survival Tidsramme: Start of therapy until progression (up to approximately 5 years)	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.	Start of therapy until progression (up to approximately 5 years)
Overall Response Tidsramme: Baseline until either response or progression (up to approximately 5 years)	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.	Baseline until either response or progression (up to approximately 5 years)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2005

Primær færdiggørelse (Faktiske)

1. februar 2014

Studieafslutning (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først indsendt

24. februar 2006

Først indsendt, der opfyldte QC-kriterier