Phase 2
Completed N=20
Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)
Source: ClinicalTrials.gov NCT00946153 ↗Enrolled (actual)
20
Serious AEs
48.5%
Results posted
Feb 2019
Primary outcomePrimary: Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib — 12; 8 milligram (mg)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib |
12; 8 | — |
| PRIMARY Phase 2: Time to Progression (TTP) by Independent Review Assessment |
7.40 | — |
| SECONDARY Phase 1: Best Overall Response (BOR) of Lenvatinib by Investigator Assessment |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Phase 1: Objective Response Rate (ORR) by Investigator Assessment |
16.7; 33.3; 16.7; 0 | — |
| SECONDARY Phase 1: Disease Control Rate (DCR) by Investigator Assessment |
50; 100; 83.3; 40.0 | — |
| SECONDARY Phase 2: Progression-free Survival (PFS) by Independent Review Assessment |
7.40 | — |
| SECONDARY Phase 2: Objective Response Rate (ORR) by Independent Review Assessment |
41.5 | — |
| SECONDARY Phase 2: Disease Control Rate (DCR) by Independent Review Assessment |
87.8; 78.0 | — |
| SECONDARY Phase 2: Overall Survival (OS) |
18.30 | — |
Eligibility Criteria
Inclusion criteria
- Histologically or clinically confirmed diagnosis of advanced HCC.
- Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
- Adequate laboratory values/organ function tests.
Exclusion criteria
- Simultaneous or metachronous cancers.
- Pericardial, ascites, or pleural effusion requiring drainage.
- Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
- Malabsorption syndrome.
- Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
- Use of drugs known to inhibit cytochrome P3A4.
Data sourced from ClinicalTrials.gov (NCT00946153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.