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Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)

maanantai 27. elokuuta 2018 päivittänyt: Eisai Co., Ltd.

Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

66

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Japani
    • Chiba
      • Kashiwa-shi, Chiba, Japani
    • Fukuoka
      • Kurume-shi, Fukuoka, Japani
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japani
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japani
    • Osaka
      • Osaka-shi, Osaka, Japani
      • Osakasayama-shi, Osaka, Japani
    • Saga
      • Saga-shi, Saga, Japani
    • Tokyo
      • Chuo-ku, Tokyo, Japani
      • Minato-ku, Tokyo, Japani
      • Musashino-shi, Tokyo, Japani
  • Korean tasavalta
    • Seoul
      • Gangnam-gu, Seoul, Korean tasavalta
      • Songpa-gu, Seoul, Korean tasavalta

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

20 vuotta - 80 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion criteria:

  1. Histologically or clinically confirmed diagnosis of advanced HCC.
  2. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
  3. Adequate laboratory values/organ function tests.

Exclusion criteria:

  1. Simultaneous or metachronous cancers.
  2. Pericardial, ascites, or pleural effusion requiring drainage.
  3. Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
  4. Malabsorption syndrome.
  5. Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
  6. Use of drugs known to inhibit cytochrome P3A4.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Lenvatinibi
Lääke: Lenvatinib
In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.
Muut nimet:
  • E7080

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib
Aikaikkuna: Up to 28 days (Cycle1)
The MTD was defined as the highest dose level at which no more than 1 of 6 participants had a dose limiting toxicities (DLT). DLT was defined as any of the following events: grade 4 or higher hematologic toxicity or grade 3 thrombocytopenia that required blood transfusion, grade 3 or higher nonhematologic toxicity, grade 4 hypertension uncontrolled by antihypertensive drug(s), aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than (>) 10.0*upper limit of normal (ULN), proteinuria 4+ by urine dipstick, proteinuria 3+ by urine dipstick was to be monitored by 24-hour urine collection, proteinuria >3.5 gram (g) for 24 hours, diarrhea/vomiting/nausea of grade 3 or higher that was uncontrollable despite maximal supportive therapies and abnormal clinical laboratory values that required no treatment, grade 3 proteinuria by dipstick, diarrhea/vomiting/nausea that was managed with supportive therapies were not considered as DLT.
Up to 28 days (Cycle1)
Phase 2: Time to Progression (TTP) by Independent Review Assessment
Aikaikkuna: From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)
TTP was defined as the time from the date of registration to the date when progressive disease (PD) was first confirmed. PD was evaluated according to modified response evaluation criteria in solid tumors (mRECIST) by an independent imaging review. PD was defined as at least a 20 percent (%) increase in the sum of long diameter (LD) of target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 millimeter (mm) (including new lesions).
From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Phase 1: Best Overall Response (BOR) of Lenvatinib by Investigator Assessment
Aikaikkuna: Every 8 weeks (approximately up to 18.4 months)
BOR was performed using RECIST1.1 and was measured as complete response (CR) defined as when an overall response of CR was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of CR was confirmed and the BOR established as CR was regarded as the "CR confirmed date), partial response (PR) defined as when the overall response of PR or better (CR or PR) was obtained 2 or more consecutive times at intervals of at least 28 days (the date when the second overall response of PR was confirmed and the BOR established as PR will be regarded as the "PR confirmed date), PD defined as when the BOR was neither CR, PR, or stable disease (SD), and the overall response was PD, SD defined as when the BOR obtained was neither CR nor PR, but no PD from the initial administration to the end of Cycle 2 and the overall response of SD or better occurred at least once and not evaluable (NE) was when the overall response was NE in all cases.
Every 8 weeks (approximately up to 18.4 months)
Phase 1: Objective Response Rate (ORR) by Investigator Assessment
Aikaikkuna: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
ORR was defined as the percentage of participants who achieved a tumor response measured by RECIST 1.1 of CR defined as disappearance of all target lesions (a short diameter is less than (<)10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
Phase 1: Disease Control Rate (DCR) by Investigator Assessment
Aikaikkuna: Up to Week 16
DCR was measured by RECIST 1.1 and defined as CR which was defined as disappearance of all target lesions (a short diameter was <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.
Up to Week 16
Phase 2: Progression-free Survival (PFS) by Independent Review Assessment
Aikaikkuna: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
PFS was defined as the time from the date of registration until the date when PD was first confirmed or death (whichever occurred first) as determined by mRECIST and PD was defined as at least a 20% increase in the sum of long diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
Phase 2: Objective Response Rate (ORR) by Independent Review Assessment
Aikaikkuna: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
ORR was defined as the percentage of participants who achieved a tumor response measured by mRECIST of CR defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR defined as at least 30% decrease in the sum of the long diameter LD (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.
From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
Phase 2: Disease Control Rate (DCR) by Independent Review Assessment
Aikaikkuna: Weeks 8 and 16
DCR was measured by mRECIST and defined as CR which was defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node) plus PR which was defined as at least 30% decrease in the sum of the long diameter (hereafter referred to as sum of LD) of all target lesions, as compared with baseline summed LD plus SD which was reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to PD.
Weeks 8 and 16
Phase 2: Overall Survival (OS)
Aikaikkuna: From day of registration to the day of death (approximately 6.1 years)
OS was defined as the time from the date of registration until the date of death.
From day of registration to the day of death (approximately 6.1 years)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Eisai Co., Ltd.

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 24. heinäkuuta 2009

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 15. kesäkuuta 2014

Opintojen valmistuminen (Todellinen)

Torstai 13. elokuuta 2015

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 23. heinäkuuta 2009

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 23. heinäkuuta 2009

Ensimmäinen Lähetetty (Arvio)

Perjantai 24. heinäkuuta 2009

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 1. helmikuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 27. elokuuta 2018

Viimeksi vahvistettu

Sunnuntai 1. heinäkuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • E7080-J081-202

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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