Back to resultsE7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Sorafenib
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Cancer, liver, hepatocellular carcinoma, phase I, phase II
Eligibility Criteria
Inclusion Criteria
- Unresectable locally advanced or metastatic HCC;
- Histologic confirmation not required if other diagnostic criteria are met;
- No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment;
- ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7;
- Blood pressure must be well-controlled (less than or equal to 140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;
Exclusion Criteria
- Previously received E7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only);
- Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
- Palliative radiotherapy is not permitted throughout the study period;
- Active hemoptysis
- Serious non-healing wound, ulcer, or active bone fracture;
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study;
- Clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt (TIPS) procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Phase Ib: Cohort 1,2, and 3
Phase II: Arm 1; E7050 + Sorafenib
Arm Description
Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
Phase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib
Outcomes
Primary Outcome Measures
Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)
DLTs were defined as clinically significant adverse events (AEs) (non-hematological, hematological and other events) occurring less than or equal to (<=) 28 days after commencing study treatment and considered to be at least possibly or probably related to study drug by the Investigator. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v.4.0).
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day -7
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day -7
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Phase 1b: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered in Combination With Sorafenib at Day -7
Phase 1b: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Phase 1b: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Phase 1b: t1/2: Terminal Elimination Half-life for Golvatinib When Administered in Combination With Sorafenib at Day -7
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Phase 2: Number of Participants With AEs by Severity Grades
AE severity was graded using CTCAE version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Higher grade indicates more severe condition.
Phase 2: Number of Participants With Adverse Events Related to Vital Signs
Number of participants are reported with AEs related to Vital signs including body temperature, respiratory rate, heart rate, height, and weight.
Phase 2: Number of Participants With Clinically Significant Change From Baseline in Blood Pressure Including Systolic and Diastolic Blood Pressures
Phase 2: Number of Participants With Worst Shifts Post Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Number of participants with worst shifts post baseline in ECOG-PS levels were reported. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Phase 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Phase 2: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
Secondary Outcome Measures
Phase 2: Time to Progression (TTP)
TTP was defined as the time from the date of randomization until the date of PD of such participants disease based on independent assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PD was defined as at least a 20% increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. TTP was estimated and analyzed using Kaplan-Meier (K-M) method.
Phase 2: Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression (2) the date of such participant's death due to any cause based on independent assessments according to RECIST v. 1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using KM method.
Phase 2: Percentage of Participants With PFS at Week 12
The PFS rate at week 12 was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression (2) the date of such participant's death due to any cause based on independent assessments according to RECIST v. 1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Phase 2: Overall Survival (OS)
OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known alive. OS was analyzed using K-M method.
Phase 2: Percentage of Participants With Overall Response
Overall response rate was defined as percentage of participants with best confirmed response (CR) or partial response (PR) assessed by investigator per RECIST v1.1. A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<)10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Full Information
NCT ID
NCT01271504
First Posted
January 5, 2011
Last Updated
April 16, 2021
Sponsor
Eisai Inc.
Collaborators
PharmaBio Development Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01271504
Brief Title
E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma
Official Title
An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Patients With Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 19, 2011 (Actual)
Primary Completion Date
June 23, 2015 (Actual)
Study Completion Date
June 23, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
Collaborators
PharmaBio Development Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.
Detailed Description
This open-label, multicenter, randomized study will consist of a Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with sorafenib; and a Phase II portion: a randomized 2-arm period. Approximately 95 patients with hepatocellular carcinoma will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion of the study. In both Phase Ib and phase II, Patients will receive study treatment (E7050 plus sorafenib or sorafenib alone) until the occurrence of progressive disease (PD)for approximately six 28-day cycles (24 weeks). After 6 cycles. ath the discretion of the Investigator and in consultation with the Medical Monitor, patients who are experiencing clinical benefit may continue E7050, with or without sorafenib (Arm 1), or may continue sorafenib alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated. Patients will be followed until death following completion of therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Cancer, liver, hepatocellular carcinoma, phase I, phase II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase Ib: Cohort 1,2, and 3
Arm Type
Active Comparator
Arm Description
Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
Arm Title
Phase II: Arm 1; E7050 + Sorafenib
Arm Type
Active Comparator
Arm Description
Phase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
E7050 given orally at 200, 300 or 400 mg once daily.
Sorafenib given orally, 400 mg twice daily.
Primary Outcome Measure Information:
Title
Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)
Description
DLTs were defined as clinically significant adverse events (AEs) (non-hematological, hematological and other events) occurring less than or equal to (<=) 28 days after commencing study treatment and considered to be at least possibly or probably related to study drug by the Investigator. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v.4.0).
Time Frame
Cycle 1 (Cycle length is 28 days)
Title
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day -7
Time Frame
Day -7: 0-72 hours post-dose
Title
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Time Frame
Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)
Title
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Time Frame
Cycle 1 Day 28: 0-24 hours post-dose
Title
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day -7
Time Frame
Day -7: 0-72 hours post-dose
Title
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Time Frame
Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)
Title
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Time Frame
Cycle 1 Day 28: 0-24 hours post-dose
Title
Phase 1b: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered in Combination With Sorafenib at Day -7
Time Frame
Day -7: 0-72 hours post-dose
Title
Phase 1b: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Time Frame
Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)
Title
Phase 1b: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Time Frame
Cycle 1 Day 28: 0-24 hours post-dose (Cycle length is 28 days)
Title
Phase 1b: t1/2: Terminal Elimination Half-life for Golvatinib When Administered in Combination With Sorafenib at Day -7
Time Frame
Day -7: 0-72 hours post-dose
Title
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Title
Phase 2: Number of Participants With AEs by Severity Grades
Description
AE severity was graded using CTCAE version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Higher grade indicates more severe condition.
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Title
Phase 2: Number of Participants With Adverse Events Related to Vital Signs
Description
Number of participants are reported with AEs related to Vital signs including body temperature, respiratory rate, heart rate, height, and weight.
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Title
Phase 2: Number of Participants With Clinically Significant Change From Baseline in Blood Pressure Including Systolic and Diastolic Blood Pressures
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Title
Phase 2: Number of Participants With Worst Shifts Post Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Description
Number of participants with worst shifts post baseline in ECOG-PS levels were reported. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Title
Phase 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Title
Phase 2: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Secondary Outcome Measure Information:
Title
Phase 2: Time to Progression (TTP)
Description
TTP was defined as the time from the date of randomization until the date of PD of such participants disease based on independent assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PD was defined as at least a 20% increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. TTP was estimated and analyzed using Kaplan-Meier (K-M) method.
Time Frame
From the date of randomization until the date of PD (up to approximately 3 years 11 months)
Title
Phase 2: Progression Free Survival (PFS)
Description
PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression (2) the date of such participant's death due to any cause based on independent assessments according to RECIST v. 1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using KM method.
Time Frame
From the date of randomization until the earlier of the following two events: the date of PD or the date of death (Up to approximately 3 years 11 months)
Title
Phase 2: Percentage of Participants With PFS at Week 12
Description
The PFS rate at week 12 was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression (2) the date of such participant's death due to any cause based on independent assessments according to RECIST v. 1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.
Time Frame
At 12 weeks
Title
Phase 2: Overall Survival (OS)
Description
OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known alive. OS was analyzed using K-M method.
Time Frame
From the date of randomization until the date of death (Up to approximately 3 years 11 months)
Title
Phase 2: Percentage of Participants With Overall Response
Description
Overall response rate was defined as percentage of participants with best confirmed response (CR) or partial response (PR) assessed by investigator per RECIST v1.1. A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<)10 mm. PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
From the date of randomization until disease progression or death (Up to approximately 3 years 11 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Unresectable locally advanced or metastatic HCC;
Histologic confirmation not required if other diagnostic criteria are met;
No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment;
ECOG PS 0 or 1; Child-Pugh Cirrhotic Status A or B with a score of 7;
Blood pressure must be well-controlled (less than or equal to 140/90 mmHg at screening) with or without antihypertensive medication. Patients must have no history of hypertensive crisis or hypertensive encephalopathy;
Exclusion Criteria
Previously received E7050 anti-cmet, or anti-angiogenic therapy (prior anti-angiogenic therapy is permitted in Phase Ib only);
Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
Palliative radiotherapy is not permitted throughout the study period;
Active hemoptysis
Serious non-healing wound, ulcer, or active bone fracture;
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to commencing study treatment, or anticipation of need for a major surgical procedure during the course of the study;
Clinically significant gastrointestinal bleeding (bleeding requiring procedural intervention, eg. variceal banding, transjugular intrahepatic portosystemic shunt (TIPS) procedure, arterial embolization, topical coagulation therapy) within 6 months prior to first dose.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa J Versola, RN
Organizational Affiliation
Quintiles, Inc.
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
City
Modena
ZIP/Postal Code
40124
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
City
London
State/Province
Greater London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G12 OYN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma
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