Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive lenvatinib 12 or 8 milligrams (mg) once daily in continuous 28-day cycles until disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. Upon completion of lenvatinib treatment, eligible participants will receive commercially available systemic TPC for hepatocellular carcinoma in the subsequent treatment period.

Lenvatinib capsules will be administered orally, once daily in continuous 28-day cycles.

Body weight (BW) ≥60 kilograms (kg) - Lenvatinib 12 mg (taken as three 4-mg capsules); BW \<60 kg - Lenvatinib 8 mg (taken as two 4-mg capsules)

The primary objective of this study is to assess the safety and tolerability of subsequent systemic treatment of physician's choice (TPC) following the first-line lenvatinib treatment in unresectable hepatocellular carcinoma (uHCC) participants.

Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)

A Single-Arm, Multicenter, Phase 2 Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)

OS is defined as the time from the date of first dose of study treatment to the date of death from any cause. Participants who are lost to follow-up are censored at the last date the participant was known to be alive, and participants who remain alive are censored at the time of data cutoff. OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.

PFS based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) (and including the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of PD, or the date of death during the subsequent systemic TPC, whichever occurs first. PD is defined at least 20% increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.

TTP based on mRECIST (and including the RECIST 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of disease progression during subsequent systemic TPC. PD is defined at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. TTP was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.

Eisai Inc.

Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW \>=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW \<60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The Safety Analysis Set (Full Analysis Set) included all participants who received at least 1 dose of the lenvatinib treatment.

The study was terminated due to difficulty in enrolling the targeted number of participants. Secondary endpoints could not be analyzed because of very low sample size. No safety concerns involved in decision to stop enrollment.

Eisai Medical Information

The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Overall Survival (OS)

Progression-free Survival (PFS)

Time to Progression (TTP)

Participants received lenvatinib 8 or 12 milligram (mg), capsule, orally, once daily in 28 day continuous cycles until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. Body weight (BW) greater than or equal to (\>=) 60 kilograms (kg) - lenvatinib 12 mg (taken as three 4 mg capsules); BW less than (\<) 60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).

Spots Global Cancer Trial Database for Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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