- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00297258
Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma
4 januari 2016 uppdaterad av: 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
148
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bruxelles, Belgien, 1000
- GSK Investigational Site
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Leuven, Belgien, 3000
- GSK Investigational Site
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Lyon cedex 03, Frankrike, 69437
- GSK Investigational Site
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Marseille, Frankrike, 13385
- GSK Investigational Site
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Paris Cedex 05, Frankrike, 75248
- GSK Investigational Site
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Villejuif, Frankrike, 94805
- GSK Investigational Site
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Groningen, Nederländerna, 9713 GZ
- GSK Investigational Site
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Leiden, Nederländerna, 2300 RC
- GSK Investigational Site
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Rotterdam, Nederländerna, 3075 EA
- GSK Investigational Site
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Glasgow, Storbritannien, G11 6NT
- GSK Investigational Site
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Leeds, Storbritannien, LS9 7TF
- GSK Investigational Site
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London, Storbritannien, SW3 6JJ
- GSK Investigational Site
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Newcastle upon Tyne, Storbritannien, NE7 7DN
- GSK Investigational Site
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Sheffield, Storbritannien, S10 2SJ
- GSK Investigational Site
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Lancashire
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Manchester, Lancashire, Storbritannien, M20 4BX
- GSK Investigational Site
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Budapest, Ungern, 01135
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Progression Free Survival at Week 12
Tidsram: Week 12
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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.
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Week 12
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Overall Survival
Tidsram: Start of therapy until death (up to approximately 5 years)
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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.
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Start of therapy until death (up to approximately 5 years)
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Progression Free Survival
Tidsram: Start of therapy until progression (up to approximately 5 years)
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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.
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Start of therapy until progression (up to approximately 5 years)
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Overall Response
Tidsram: Baseline until either response or progression (up to approximately 5 years)
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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.
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Baseline until either response or progression (up to approximately 5 years)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2005
Primärt slutförande (Faktisk)
1 februari 2014
Avslutad studie (Faktisk)
1 februari 2014
Studieregistreringsdatum
Först inskickad
24 februari 2006
Först inskickad som uppfyllde QC-kriterierna
24 februari 2006
Första postat (Uppskatta)
28 februari 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
3 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 januari 2016
Senast verifierad
1 december 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VEG20002
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Sarkom, mjuk vävnad
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University GhentOsteology FoundationAktiv, inte rekryterande
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OnxeoSpectrum Pharmaceuticals, IncAvslutadDoseskalering: Fasta tumörer | MTD: Soft Tissue SarkomDanmark, Storbritannien
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The Netherlands Cancer InstituteOkändMyxoid Liposarcoma of Soft TissueNederländerna, Storbritannien, Norge, Förenta staterna, Danmark
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National Cancer Institute (NCI)RekryteringMetastaserande alveolär mjukdel sarkom | Ooperabelt alveolärt mjukdelssarkom | Avancerat mjukdelssarkom | Advanced Alveolar Soft Part SarkomFörenta staterna
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Eastern Cooperative Oncology GroupRekryteringMelanom | Bröstcancer, NOS | CNS primär tumör, NOS | Livmoderhalscancer, NOS | Kolorektal cancer, NOS | Leukemi, NOS | Lymfom, NOS | Diverse Neoplasm, NOS | Non-Rhabdomyosarcoma Soft Tissue Sarkom, NOS | Testikulär icke-seminomatös könscellstumör, NOS | Sköldkörtelcancer, NOS | Bencancer, NOSFörenta staterna
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Dana-Farber Cancer InstituteAvslutadSarkom | Mjukvävnadssarkom | Clear Cell Renal Cell Carcinom | Osteosarkom | Sarkom, Ewing | Ewing Sarkom | Rhabdoid tumör | Njurtumör | Rabdomyosarkom | Wilms tumör | Non-Rhabdomyosarcoma Soft Tissue Sarcoma, NosFörenta staterna
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National Cancer Institute (NCI)AvslutadRabdomyosarkom | Återkommande osteosarkom | Återkommande barndomsrabdomyosarkom | Tidigare behandlad rabdomyosarkom i barndomen | Återkommande mjukdelssarkom från barndomen | Återkommande Ewing-sarkom/perifer primitiv neuroektodermal tumör | Angiosarkom i barndomen | Epiteloid sarkom från barndomen | Fibrosarkom... och andra villkorFörenta staterna, Kanada
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National Cancer Institute (NCI)Aktiv, inte rekryterandeMjukvävnadssarkom | Njurcellscancer | Hepatocellulärt karcinom | Osteosarkom | Ewing Sarkom | Återkommande njurcellscancer | Eldfast malignt fast neoplasma | Rabdomyosarkom | Återkommande Ewing Sarkom | Återkommande hepatoblastom | Återkommande malignt fast neoplasma | Återkommande osteosarkom | Återkommande rabdomyosarkom och andra villkorFörenta staterna
Kliniska prövningar på pazopanib
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Cure HHTUniversity of North CarolinaHar inte rekryterat ännuEpistaxis | Ärftlig hemorragisk telangiektasi
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Illinois CancerCare, P.C.AvslutadIcke småcellig lungcancerFörenta staterna
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Fondazione IRCCS Istituto Nazionale dei Tumori,...Avslutad
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Gynecologic Oncology GroupGlaxoSmithKlineIndragenUterin leiomyosarkom
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Novartis PharmaceuticalsAvslutadMetastaserande njurcellscancer | Avancerat njurcellscancerSpanien, Tyskland, Förenta staterna, Österrike, Tjeckien, Storbritannien, Argentina, Ungern, Frankrike, Kanada, Chile
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Samsung Medical CenterAvslutadRefraktära fasta tumörerKorea, Republiken av
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Grupo Espanol de Investigacion en SarcomasGlaxoSmithKlineAvslutadAvancerat och/eller metastaserande liposarkomSpanien, Tyskland
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Grupo Espanol de Tumores NeuroendocrinosAvslutad
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Seoul National University HospitalSamsung Medical Center; Asan Medical Center; Seoul National University Bundang... och andra samarbetspartnersAvslutadMetastaserande alveolär mjukdel sarkomKorea, Republiken av
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Interessenverband zur Qualitätssicherung der Arbeit...OnkoDataMed GmbHAvslutadMetastaserande njurcellscancer | Lokalt avancerad njurcellscancerTyskland