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Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma

4. Januar 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Sarkom, Weichgewebe

Intervention / Behandlung

Arzneimittel: pazopanib

Studientyp

Interventionell

Einschreibung (Tatsächlich)

148

Phase

Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: Nicht randomisiert
Interventionsmodell: Einzelgruppenzuweisung
Maskierung: Keine (Offenes Etikett)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Progression Free Survival at Week 12 Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Overall Survival Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2005

Primärer Abschluss (Tatsächlich)

1. Februar 2014

Studienabschluss (Tatsächlich)

1. Februar 2014

Studienanmeldedaten

Zuerst eingereicht

24. Februar 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat