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The primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events [SAEs], grade 3 to 5 adverse events [AEs], dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib | Participants with advanced or unresectable HCC will initiate treatment with lenvatinib capsules based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first. |
| |
| Sorafenib | Participants with advanced or unresectable HCC will initiate treatment with sorafenib tablets based on physicians decision and will be observed until withdrawal of consent, loss to follow-up, death or until the end of the study (up to 7 years) whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | Oral capsules. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib | Up to 7 years | |
| Number of Participants With SAEs With Lenvatinib | Up to 7 years | |
| Number of Participants With Grade 3 to 5 AEs With Lenvatinib | AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with lenvatinib. AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs. | Up to 7 years |
| Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib | Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib will be collected at the discretion of the treating physician and in accordance with the prescribing information. | Up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Lenvatinib and Sorafenib Treatment | Up to 7 years | |
| Number of Participants With Dose Interruption and Dose Reduction for Lenvatinib | Up to 7 years | |
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Inclusion Criteria:
Exclusion Criteria:
None
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Participant with advanced or unresectable hepatocellular carcinoma.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Liver Research Institute | Pasadena | California | 91105 | United States | ||
| Montefiore Medical Center |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| Sorafenib | Drug | Oral tablets. |
|
| Relative Dose Intensity of Lenvatinib and Sorafenib |
Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen. |
| Up to 7 years |
| Overall Survival (OS) For Lenvatinib and Sorafenib | OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause. | Up to 7 years |
| Number of Participants With Dose Interruption and Dose Reduction for Sorafenib | Up to 7 years |
| Number of Participants With Hepatotoxicity TEAEs With Sorafenib | Up to 7 years |
| Number of Participants With SAEs With Sorafenib | Up to 7 years |
| Number of Participants With Grade 3 to 5 AEs With Sorafenib | AEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment with sorafenib. AEs will be graded using NCI CTCAE. Here Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activity of daily living, Grade 4: life-threatening consequences; urgent intervention indicated and Grade 5: death related to AEs. | Up to 7 years |
| Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib | Number of participants with one or more TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib will be collected at the discretion of the treating physician and in accordance with the prescribing information. | Up to 7 years |
| The Bronx |
| New York |
| 10467 |
| United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-0001 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 1871 | Australia |
| Monash Health, Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Universitätsklinikum Innsbruck | Innsbruck | Tyrol | Austria |
| Klinikum Klagenfurt Am Woerthersee | Klagenfurt | 9020 | Austria |
| Universitätsklinikum St. Pölten | Sankt Pölten | 3100 | Austria |
| Medizinische Universitat Wien (Medical University of Vienna) | Vienna | 1090 | Austria |
| Eisai Trial Site #3 | Cologne | North Rhine-Westphalia | Germany |
| Eisai Trial Site #5 | Mainz | Rhineland-Palatinate | Germany |
| Eisai Trial Site #2 | Berlin | Germany |
| Eisai Trial Site #6 | Munich | Germany |
| Eisai Trial Site #1 | Ulm | Germany |
| Ospedale del Mare | Naples | Campania | 80147 | Italy |
| Fondazione PTV Policlinico Tor Vergata | Rome | Lazio | 00133 | Italy |
| Azienda Ospedaliera San Camillo Forlanini | Rome | Lazio | 00152 | Italy |
| Fondazione Policlinico Universitario A Gemelli | Rome | Lazio | 00168 | Italy |
| Azienda Ospedaliero Universitaria Di Cagliari | Monserrato Cagliari | Sardinia | 09042 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | 40138 | Italy |
| Hospital Garcia de Orta | Almada | Setúbal District | 2805-267 | Portugal |
| Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE | Coimbra | Portugal |
| Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar Trás Os Montes E Alto Douro EPE | Vila Real | 5000-508 | Portugal |
| Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar | Cheboksary | Chuvashskaya Respublika | 428020 | Russia |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Virgen de La Arrixaca | El Palmar | Murcia | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| C.H. Regional Reina Sofia - PPDS | Córdoba | 14004 | Spain |
| Hospital Universitario de Getafe | Getafe | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Regional Universitario de Malaga - Hospital General | Málaga | Spain |
| CHUS - H. Clinico U. de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Seville | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Spain |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | 141 86 | Sweden |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2PR | United Kingdom |
| Barts Health NHS Trust - Charterhouse Square | London | EC1A 7BE | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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