- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00121680
A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma
The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas.
Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.
In the current phase of this study, To determine the MTD and the pharmacokinetic profile of E7080 when given as continuous daily (qd) dosing in combination with temozolomide.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Texas
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Dallas, Texas, Verenigde Staten
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Houston, Texas, Verenigde Staten
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Patients with a histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no curative therapies are available All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved Aged 18 years. Because of the potential additional risk to children suggested by preclinical models of dysplasia in growing epiphyseal growth plates, enrollment will be limited to adult patients ECOG performance status score of 0 or 1 Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice Willing and able to comply with the protocol guidelines for the duration of the study For patients in the Schedule 2 Expanded Melanoma Cohort only: histologically and/or cytologically confirmed advanced and/or metastatic melanoma who are resistant/refractory to approved therapies or for whom no curative therapies are available. In addition, patients must have melanoma lesions amenable to tissue biopsy and must agree to undergo biopsies of malignant and adjacent non-malignant tissue pretreatment and at the end of Cycle 1 of treatment For patients in the Melanoma Combination Cohort only: histologically and/or cytologically confirmed melanoma that is advanced and/or metastatic
Exclusion Criteria:
Untreated or unstable metastases to the central nervous system (CNS) tumors. Patients who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and in whom stability has been proven by at least 2 CT or MRI scans obtained at least 4 weeks apart are permitted Any of the following laboratory parameters: hemoglobin < 9 g/dL (5.6 mmol/L); neutrophils <1.5 x 109/L; platelets <100 x 109/L; serum bilirubin >25 mol/L (1.5 mg/dL); liver function tests with values >3 x upper limit of normal (ULN); renal function with serum creatinine >1.5 ULN or creatinine clearance < 60 mL/min Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection Patients with centrally located non-small cell lung cancers and squamous cell lung cancers Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start Patients with marked Baseline prolongation of QT/QTc interval (QTc interval > 450 msec for males or > 470 msec for females) using the Fridericia method for QTc analysis Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin. Occasional use of NSAIDs and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken <7 days per 28 days. However, if the patient requires chronic use (>/=7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excluded. Concomitant antiplatelet agents and NSAIDs should be used with caution Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) Poorly controlled hypertension (defined as requiring changes in any hypertensive regimen within 1 week three months of study entry) or patients diagnosed with hypertension based on repeat blood pressure measurements of >160/90 mmHg at Screening >1+ proteinuria on urine dipstick testing or 30 mg/dL A history of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within four weeks of starting therapy or who have not recovered from major surgery within three weeks of starting therapy History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance Any treatment with investigational drugs within 30 days before the start of the study Previous treatment with E7080 Known intolerance to temozolomide (or any of the excipients) Women who are pregnant or breast-feeding; women of childbearing potential with 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 (including two forms of contraception, one of which must be a barrier method) in the opinion of the Investigator (revised per Amendment 04). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contraceptive protection Legal incapacity
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
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Oral.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To determine the maximum tolerated dose (MTD) of E7080 for two different schedules incorporating dose interruptions.
Tijdsspanne: Every two cycles.
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Every two cycles.
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Identify the dose limiting toxicities (DLT); explore safety and tolerability; determine pharmacokinetic profile; explore anti-tumor efficacy.
Tijdsspanne: Every two cycles.
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Every two cycles.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Eisai Inc., Eisai Limited
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-endocriene tumoren
- Nevi en melanomen
- Melanoma
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Lenvatinib
Andere studie-ID-nummers
- E7080-A001-102
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 .
Klinische onderzoeken op Gemetastaseerd melanoom
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National Taiwan University HospitalOnbekend
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The Netherlands Cancer InstituteOnbekendStadium IV huidmelanoom | Oog; MelanomaNederland
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University of AarhusDanish Cancer Society; AmbuFlexVoltooidMelanoma | Kwaliteit van het levenDenemarken
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Herlev HospitalVoltooidMelanoma | HuidkankerDenemarken
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Herlev HospitalVoltooidGeïntegreerde basiswetenschap binnen het instructieontwerp van patroonherkenningstraining (AISC-ISF)Melanoma | HuidkankerDenemarken
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University Medical Center GroningenWervingMelanoma | Hoofd- en nekneoplasmata | MSI-H-kankerNederland
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Vanderbilt-Ingram Cancer CenterWren Laboratories LLCVoltooidMelanomaVerenigde Staten
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Mayo ClinicActief, niet wervendMelanoma | Borstkanker | LymfoedeemVerenigde Staten
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University of UtahVoltooidMelanoma | JongvolwasseneVerenigde Staten
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WervingGlioom | Hematopoietisch en lymfoïde celneoplasma | Kwaadaardig solide neoplasma | Melanoma | SarcoomVerenigde Staten
Klinische onderzoeken op E7080
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Emory UniversityNational Cancer Institute (NCI); Eisai Co., Ltd.WervingInoperabel hepatocellulair carcinoom | Recidiverend hepatocellulair carcinoom | Stadium III hepatocellulair carcinoom AJCC v8 | Stadium IIIA Hepatocellulair carcinoom AJCC v8 | Stadium IV hepatocellulair carcinoom AJCC v8 | Stadium IVA Hepatocellulair carcinoom AJCC v8 | Stadium IVB Hepatocellulair... en andere voorwaardenVerenigde Staten
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Emory UniversityEisai Inc.BeëindigdGedifferentieerd schildkliercarcinoom | Folliculair carcinoom van de schildklier | Schildklier papillair carcinoomVerenigde Staten
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Mayo ClinicNational Cancer Institute (NCI)VoltooidGemetastaseerd bijnierfeochromocytoom | Kwaadaardig bijnierfeochromocytoom | Kwaadaardig paraganglioomVerenigde Staten
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M.D. Anderson Cancer CenterWervingRecidiverend primair peritoneaal hooggradig sereus adenocarcinoom | Hoogwaardig ovarium sereus adenocarcinoom | Terugkerend hooggradig sereus adenocarcinoom van de eileider | Terugkerend hooggradig ovarium sereus adenocarcinoom | Hoogwaardig sereus adenocarcinoom van de eileider | Peritoneaal...Verenigde Staten
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Eisai Co., Ltd.VoltooidHepatocellulair carcinoomJapan, Korea, republiek van
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Eisai Inc.VoltooidLeverfunctiestoornis | LeverfunctieVerenigde Staten
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WervingSlecht gedifferentieerd schildkliercarcinoom | Schildklier plaveiselcelcarcinoom | Inoperabel schildkliercarcinoom | Gemetastaseerd schildkliercarcinoom | Stadium IVB Anaplastisch carcinoom van de schildklier AJCC v8 | Stadium IVC Schildklier Anaplastisch Carcinoom AJCC v8Verenigde Staten
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Humanity & Health Medical Group LimitedBeijing 302 Hospital; Kindai University Faculty of MedicineBeëindigdHepatocellulair carcinoomHongkong
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Eisai Inc.Voltooid
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Eisai Inc.VoltooidStadium IV melanoom | Inoperabele fase IIIVerenigde Staten, Verenigd Koninkrijk, Australië, Duitsland