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Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

4 gennaio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Sarcoma, tessuto molle

Intervento / Trattamento

Droga: pazopanib

Tipo di studio

Interventistico

Iscrizione (Effettivo)

148

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Non randomizzato
Modello interventistico: Assegnazione di gruppo singolo
Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Progression Free Survival at Week 12 Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Overall Survival Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2005

Completamento primario (Effettivo)

1 febbraio 2014

Completamento dello studio (Effettivo)

1 febbraio 2014

Date di iscrizione allo studio

Primo inviato

24 febbraio 2006

Primo inviato che soddisfa i criteri di controllo qualità