Clinical trial NCT00946153: Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)
Official title: Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Carcinoma
Hepatocellular
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib
timeFrame: Up to 28 days (Cycle1)
measure: Phase 2: Time to Progression (TTP) by Independent Review Assessment
timeFrame: From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)
Secondary outcomes:
measure: Phase 1: Best Overall Response (BOR) of Lenvatinib by Investigator Assessment
timeFrame: Every 8 weeks (approximately up to 18.4 months)
measure: Phase 1: Objective Response Rate (ORR) by Investigator Assessment
timeFrame: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
measure: Phase 1: Disease Control Rate (DCR) by Investigator Assessment
timeFrame: Up to Week 16
measure: Phase 2: Progression-free Survival (PFS) by Independent Review Assessment
timeFrame: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
measure: Phase 2: Objective Response Rate (ORR) by Independent Review Assessment
timeFrame: From day of registration to the day when PD was first confirmed or death (approximately 6.1 years)
measure: Phase 2: Disease Control Rate (DCR) by Independent Review Assessment
timeFrame: Weeks 8 and 16
measure: Phase 2: Overall Survival (OS)
timeFrame: From day of registration to the day of death (approximately 6.1 years)
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
state: Chiba
city: Kurume-shi
country: Japan
state: Fukuoka
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kawasaki-shi
country: Japan
state: Kanagawa
city: Osaka-shi
country: Japan
state: Osaka
city: Osakasayama-shi
country: Japan
state: Osaka
city: Saga-shi
country: Japan
state: Saga
city: Chuo-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Musashino-shi
country: Japan
state: Tokyo
city: Gangnam-gu
country: Korea, Republic of
state: Seoul
city: Songpa-gu
country: Korea, Republic of
state: Seoul
Study officials:
References:
citation: Ikeda K, Kudo M, Kawazoe S, Osaki Y, Ikeda M, Okusaka T, Tamai T, Suzuki T, Hisai T, Hayato S, Okita K, Kumada H. Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma. J Gastroenterol. 2017 Apr;52(4):512-519. doi: 10.1007/s00535-016-1263-4. Epub 2016 Oct 4.