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Study Of Eribulin (E7389) In Patients With Advanced Solid Tumors And Normal Or Reduced Hepatic Function As Per Child-Pugh System
21 maart 2012 bijgewerkt door: Eisai Inc.
An Open-label, Parallel Group Study to Explore the Pharmacokinetics of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors and Normal or Reduced Hepatic Function According to the Child-Pugh System
This is an open-label, three-parallel group pharmacokinetic study.
Patients with advanced solid tumors will be assigned to one of three groups to receive I.V. doses of eribulin (E7389).
The three groups are: normal hepatic function, mild hepatic impairment (Child-Pugh A) and moderate hepatic impairment (Child-Pugh B) according to the Child-Pugh System for classifying hepatic impairment.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
18
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Amsterdam, Nederland, 1066 CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Utrecht, Nederland
- Utrecht Medical Centre
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Patients must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy)
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Life expectancy of ≥ 3 months
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 40 mL/minute (min) per the Cockcroft and Gault formula.
- Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, hemoglobin ≥ 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count ≥ 100 x 10^9/L
- Patients willing and able to comply with the study protocol for the duration of the study
- Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
Additional Inclusion Criteria for the Group of Patients with No Hepatic Impairment:
- All the general inclusion criteria listed above plus: Normal hepatic function as evidenced by bilirubin ≤ 34 μmol/l (≤2.0 mg/dL) and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) ≤3 times the upper limits of normal (ULN) (in the case of liver metastases ≤5 x ULN), or in the case of bone metastases, the liver specific alkaline phosphatase ≤3 times the upper limits of normal (ULN), and in the case of concomitant liver metastases, ≤5 x ULN.
Additional Inclusion Criteria for the Group of Patients with Hepatic Impairment:
All the general inclusion criteria listed above plus:
- Mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic dysfunction according to the Child-Pugh scoring system criteria, where patients with laboratory values within normal ranges will not be included in the Child-Pugh A category
- Or, Moderate hepatic dysfunction (Child-Pugh B) according to the Child-Pugh scoring system criteria
Exclusion Criteria:
Patients who have received any of the following treatments within the specified period before E7389 treatment start:
- Chemotherapy, radiation, biological therapy within 3 weeks.
- Hormonal therapy within 1 week.
- Any investigational drug within 4 weeks.
- Patients with any clinically significant laboratory abnormality except for those parameters influenced by hepatic impairment.
- Patients with severe (Child-Pugh C) hepatic dysfunction according to the Child-Pugh scoring system.
- Patients with encephalopathy ≥ Grade 1.
- Patients receiving any drug known to induce or inhibit CYP3A4 activity. Clinically significant drugs are listed in a comprehensive list that can be found at http://medicine/iupui.edu/flockhart/table.htm.
- Patients, who require therapeutic anti-coagulant therapy other than for line patency with warfarin or related compounds and cannot be changed to heparin-based therapy, are not eligible.
- Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Fertile men who are not willing to use contraception or fertile men with a female partner who are not willing to use contraception
- Severe/uncontrolled intercurrent illness/infection.
- Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association [NYHA] Grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).
- Patients with organ allografts requiring immunosuppression (not including blood and blood components transfusions).
- Patients with known positive HIV status.
- Patients with brain or subdural metastases are not eligible, unless they are stable and have completed local therapy and have discontinued the use of corticosteroids for this indication for at least four weeks before starting treatment with E7389.
- Patients with meningeal carcinomatosis.
- Patients with a hypersensitivity to halichondrin B and/or halichondrin B-like compounds.
- Patients who participated in a prior E7389 clinical trial.
- Patients with preexisting neuropathy > Grade 2.
- Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: E7389 1.4 mg/m^2
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E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
Andere namen:
E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
Andere namen:
E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
Andere namen:
|
Experimenteel: E7389 1.1 mg/m^2
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E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
Andere namen:
E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
Andere namen:
E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
Andere namen:
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Experimenteel: E7839 0.7 mg/m^2
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E7389 Intravenous injection starting dose on Day 1 is 1.4 mg/m^2 for normal hepatic function.
Andere namen:
E7389 Intravenous injection starting dose on Day 1 is 1.1 mg/m^2 for mild hepatic impairment (Child-Pugh A)
Andere namen:
E7389 Intravenous injection starting dose on Day 1 is 0.7 mg/m^2 for moderate hepatic impairment (Child-Pugh B)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)
Tijdsspanne: Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.
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Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.
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Mean (SD) Pharmacokinetic (PK) Parameter Maximum Observed Plasma Concentration (Cmax)
Tijdsspanne: Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.
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Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.
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Best Overall Response Per Response Evaluation Criteria in Solid Tumors (RECIST)
Tijdsspanne: throughout the study and up to 30 days after the last dose of study drug
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Defined as the best response from the start of treatment until disease progression or recurrence.
Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI).
Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
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throughout the study and up to 30 days after the last dose of study drug
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Prof. JHM Schellens, National Cancer Institute-Antoni van Leuwenhoek Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2008
Primaire voltooiing (Werkelijk)
1 september 2009
Studie voltooiing (Werkelijk)
1 april 2010
Studieregistratiedata
Eerst ingediend
4 februari 2008
Eerst ingediend dat voldeed aan de QC-criteria
26 juni 2008
Eerst geplaatst (Schatting)
27 juni 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
27 maart 2012
Laatste update ingediend die voldeed aan QC-criteria
21 maart 2012
Laatst geverifieerd
1 maart 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- E7389-E044-108
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Klinische onderzoeken op E7389
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Eisai Inc.VoltooidWekedelensarcoomFrankrijk, Duitsland, België, Denemarken, Polen
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Eisai Inc.VoltooidNiet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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Eisai Co., Ltd.Actief, niet wervend
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Eisai Inc.VoltooidKankerVerenigde Staten, Oostenrijk, Indië
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Eisai LimitedVoltooid
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National Cancer Institute (NCI)VoltooidHoofd-halskankerVerenigde Staten
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Eisai Inc.Children's Oncology GroupVoltooidVaste tumoren | KindergeneeskundeVerenigde Staten
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Eisai Inc.Voltooid