NCT03433703

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Lenvatinib	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)

Timeline

• Start date: 2018-04-26
• Primary completion: 2019-01-07
• Completion: 2019-01-07
• First posted: 2018-02-14
• Last updated: 2019-12-06
• Results posted: 2019-12-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study