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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03433703|
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Drug: Lenvatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||April 26, 2018|
|Estimated Primary Completion Date :||June 9, 2020|
|Estimated Study Completion Date :||June 9, 2020|
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, participants may continue to receive commercially available treatment 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)
- Number of Participants with Treatment-emergent Adverse Events [ Time Frame: Up to 30 months ]
- Number of Participants with Treatment-emergent Serious Adverse Events [ Time Frame: Up to 30 months ]
- Overall Survival (OS) [ Time Frame: Up to 30 months ]OS will be measured from the date of the first dose of study treatment until the date of death from any cause.
- Progression-free Survival (PFS) [ Time Frame: Up to 30 months ]PFS 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, or the date of death during the subsequent treatment of physician choice (TPC), whichever occurs first.
- Time to Progression (TTP) [ Time Frame: Up to 30 months ]TTP 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 TPC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433703
|Contact: Eisai Medical Information, EJfirstname.lastname@example.org|
|United States, California|
|California Liver Research Institute||Recruiting|
|Pasadena, California, United States, 91105|
|Contact: Edward, MD|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|United States, Louisiana|
|Ochsner Clinic Foundation||Recruiting|
|New Orleans, Louisiana, United States, 70121|