STELLAR: A Study to Evaluate the Safety and Tolerability of Lenvatinib in Participants With Advanced or Unresectable Hepatocellular Carcinoma

Sponsor

Eisai Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04763408

Collaborator

(none)

1,000

Enrollment

Locations

83.7

Anticipated Duration (Months)

20.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Drug: Lenvatinib Drug: Sorafenib

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients With Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)

Actual Study Start Date :

Apr 9, 2021

Anticipated Primary Completion Date :

Mar 31, 2028

Anticipated Study Completion Date :

Mar 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Lenvatinib Oral capsules. Other Names: Lenvima E7080
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.	Drug: Sorafenib Oral tablets.

Arm

Intervention/Treatment

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.

Drug: Lenvatinib

Oral capsules.

Other Names:

Lenvima

E7080

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.

Drug: Sorafenib

Oral tablets.

Outcome Measures

Primary Outcome Measures

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 [Up to 7 years]
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.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib [Up to 7 years]
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.

Secondary Outcome Measures

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]
Relative Dose Intensity of Lenvatinib and Sorafenib [Up to 7 years]
Relative Dose Intensity is defined as the amount of drug administered divided by the total dose specified by the corresponding standard regimen.
Overall Survival (OS) For Lenvatinib and Sorafenib [Up to 7 years]
OS is defined as the time from the start of lenvatinib and sorafenib treatment to date of death from any cause.
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 [Up to 7 years]
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.
Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Sorafenib [Up to 7 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with advanced or unresectable HCC for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label
Participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Fresno	Clovis	California	United States	93701
2	California Liver Research Institute	Pasadena	California	United States	91105
3	Mercy Medical Center (Baltimore)	Baltimore	Maryland	United States	21205
4	Montefiore Medical Center	Bronx	New York	United States	10467
5	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390-0001
6	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
7	Liverpool Hospital	Liverpool	New South Wales	Australia	1871
8	Monash Health, Monash Medical Centre	Clayton	Victoria	Australia	3168
9	The Alfred Hospital	Melbourne	Victoria	Australia	3004
10	Universitätsklinikum Innsbruck	Innsbruck	Tirol	Austria
11	Klinikum Klagenfurt Am Woerthersee	Klagenfurt Am Woerthersee		Austria	9020
12	Universitätsklinikum St. Pölten	St. Pölten		Austria	3100
13	Medizinische Universitat Wien (Medical University of Vienna)	Vienna		Austria	1090
14	Eisai Trial Site #4	Düsseldorf	Nordrhein-Westfalen	Germany
15	Eisai Trial Site #3	Köln	Nordrhein-Westfalen	Germany
16	Eisai Trial Site #5	Mainz	Rheinland-Pfalz	Germany
17	Eisai Trial Site #2	Berlin		Germany
18	Eisai Trial Site #6	Munich		Germany
19	Eisai Trial Site #1	Ulm		Germany
20	Ospedale del Mare	Napoli	Campania	Italy	80147
21	Fondazione PTV Policlinico Tor Vergata	Roma	Lazio	Italy	00133
22	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio	Italy	00152
23	Fondazione Policlinico Universitario A Gemelli	Roma	Lazio	Italy	00168
24	Azienda Ospedaliero Universitaria Di Cagliari	Monserrato Cagliari	Sardegna	Italy	09042
25	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi	Bologna		Italy	40138
26	Hospital Garcia de Orta	Almada	Setúbal	Portugal	2805-267
27	Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE	Coimbra		Portugal
28	Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisboa		Portugal	1649-035
29	Centro Hospitalar Trás Os Montes E Alto Douro EPE	Vila Real		Portugal	5000-508
30	Budgetary Institution of the Chuvash Republic-The Republican Clinical Oncologic Dispensary-Cheboksar	Cheboksary	Chuvashskaya Respublika	Russian Federation	428020
31	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona	Spain
32	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
33	Hospital Universitario Virgen de La Arrixaca	El Palmar	Murcia	Spain
34	Hospital General Universitario de Alicante	Alicante		Spain	03010
35	C.H. Regional Reina Sofia - PPDS	Córdoba		Spain	14004
36	Hospital Universitario de Getafe	Getafe		Spain
37	Hospital Universitario de Canarias	La Laguna		Spain
38	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
39	Hospital Regional Universitario de Malaga - Hospital General	Málaga		Spain
40	CHUS - H. Clinico U. de Santiago	Santiago de Compostela		Spain	15706
41	Hospital Universitario Virgen del Rocio - PPDS	Sevilla		Spain
42	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026
43	Hospital Clinico Universitario Lozano Blesa	Zaragoza		Spain
44	Hospital Universitario Miguel Servet	Zaragoza		Spain
45	Karolinska Universitetssjukhuset Huddinge	Stockholm		Sweden	141 86
46	University Hospitals Birmingham NHS Foundation Trust	Birmingham		United Kingdom	B15 2PR
47	Barts Health NHS Trust - Charterhouse Square	London		United Kingdom	EC1A 7BE
48	Royal Free London NHS Foundation Trust	London		United Kingdom	NW3 2QG
49	Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom	NG7 2UH