Hepatocellular CarcinomaPhase 1/2NCT01271504
E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma
A Phase 1/2 study testing Sorafenib in people with Hepatocellular Carcinoma, run by Eisai Inc. at 24 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 19 Jul 2011to 23 Jun 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
United States7 sites
Study site
Chapel Hill, North Carolina, 27599
Study site
Cincinnati, Ohio, 45267
Study site
Fort Myers, Florida, 33905
Study site
Nashville, Tennessee, 37203
Study site
St. Petersburg, Florida, 33705
Study site
Toledo, Ohio, 43623
Study site
Tucson, Arizona, 85715
Spain4 sites
Study site
Madrid, 28007
Study site
Madrid, 28034
Study site
Madrid, 28046
Study site
Madrid, 28050
Ukraine4 sites
Study site
Dnipropetrovsk, 49102
Study site
Donetsk, 83092
Study site
Kharkiv, 61037
Study site
Lviv, 79031
Belgium3 sites
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Leuven, 3000
Italy3 sites
Study site
Modena, 40124
Study site
Pavia, 27100
Study site
Rozzano, Milano, 20089
United Kingdom3 sites
Study site
Glasgow, Strathclyde, G12 OYN
Study site
London, Greater London, WC1E 6BT
Study site
Manchester, Greater Manchester, M20 4BX
About this study
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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib
- Keywords
- Cancer, liver, hepatocellular carcinoma, phase I, phase II
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
SorafenibDrug
E7050 given orally at 200, 300 or 400 mg once daily.
Sorafenib given orally, 400 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib: Cohort 1,2, and 3 | Active comparator | Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib Receives: Drug: Sorafenib |
| Phase II: Arm 1; E7050 + Sorafenib | Active comparator | Phase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Cycle 1 (Cycle length is 28 days)
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day -7
Measured: Day -7: 0-72 hours post-dose
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Measured: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)
Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Measured: Cycle 1 Day 28: 0-24 hours post-dose
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day -7
Measured: Day -7: 0-72 hours post-dose
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1
Measured: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)
Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1
Measured: Cycle 1 Day 28: 0-24 hours post-dose
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
Measured: Day -7: 0-72 hours post-dose
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
Measured: Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)
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
Measured: Cycle 1 Day 28: 0-24 hours post-dose (Cycle length is 28 days)
Phase 1b: t1/2: Terminal Elimination Half-life for Golvatinib When Administered in Combination With Sorafenib at Day -7
Measured: Day -7: 0-72 hours post-dose
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
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.
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
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.
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Phase 2: Number of Participants With Clinically Significant Change From Baseline in Blood Pressure Including Systolic and Diastolic Blood Pressures
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
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).
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Phase 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Phase 2: Number of Participants With Markedly Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)
Secondary outcomes (5)
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.
Measured: From the date of randomization until the date of PD (up to approximately 3 years 11 months)
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.
Measured: 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)
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.
Measured: At 12 weeks
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.
Measured: From the date of randomization until the date of death (Up to approximately 3 years 11 months)
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.
Measured: From the date of randomization until disease progression or death (Up to approximately 3 years 11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study start19 Jul 2011
- Primary completion23 Jun 2015
- Study completion23 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaBio Development Inc.
- Responsible party
- Sponsor
- Investigators
- Melissa J Versola, RN, Study director, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271504
- Sponsor's protocol ID
- E7050-701
- Other IDs
- 2011-000752-41
- Status last verified
- Aug 2017
- First submitted
- 5 Jan 2011
- Last updated
- 12 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01271504
- Acronym / sponsor ID
- E7050-701
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Cancer, liver, hepatocellular carcinoma, phase I, phase II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- PharmaBio Development Inc.
- Study start
- 19 Jul 2011 (actual)
- Primary completion
- 23 Jun 2015 (actual)
- Study completion
- 23 Jun 2015 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ib: Cohort 1,2, and 3 | Active comparator | Drug: SorafenibPhase 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 + Sorafenib | Active comparator | Drug: SorafenibPhase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibPhase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib | Drug | Phase Ib: Cohort 1,2, and 3 |
| SorafenibE7050 given orally at 200, 300 or 400 mg once daily. Sorafenib given orally, 400 mg twice daily. | Drug | Phase II: Arm 1; E7050 + Sorafenib |
Primary outcome
Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)
Time frame: Cycle 1 (Cycle length is 28 days)
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
Time frame: Day -7: 0-72 hours post-dose
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)
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
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
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)
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
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
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)
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)
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
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)
Phase 2: Number of Participants With AEs by Severity Grades
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)
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
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)
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
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)
Phase 2: Number of Participants With Worst Shifts Post Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
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)
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
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)
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)
5 secondary outcomes
Phase 2: Time to Progression (TTP)
Time frame: From the date of randomization until the date of PD (up to approximately 3 years 11 months)
Phase 2: Progression Free Survival (PFS)
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)
Phase 2: Percentage of Participants With PFS at Week 12
Time frame: At 12 weeks
Phase 2: Overall Survival (OS)
Time frame: From the date of randomization until the date of death (Up to approximately 3 years 11 months)
Phase 2: Percentage of Participants With Overall Response
Time frame: From the date of randomization until disease progression or death (Up to approximately 3 years 11 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa J Versola, RN study director
Quintiles, Inc.
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sorafenib in people with Hepatocellular Carcinoma, run by Eisai Inc. at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Spain, Ukraine, Belgium, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT) (time frame: Cycle 1 (Cycle length is 28 days)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.