NCT01271504 is a Phase 1, PHASE2 clinical trial of Sorafenib in Hepatocellular Carcinoma, sponsored by Eisai Inc..

Who is sponsoring NCT01271504?

NCT01271504 is sponsored by Eisai Inc..

What drugs are being tested in NCT01271504?

Interventions in NCT01271504: Sorafenib, Sorafenib.

What condition does NCT01271504 study?

NCT01271504 studies Hepatocellular Carcinoma.

Is NCT01271504 still recruiting?

NCT01271504 is currently completed. Last updated 12 May 2021.

Are results published for NCT01271504?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-05-12 · How we verify

NCT01271504

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

E7050 in Combination With Sorafenib Versus Sorafenib Alone as First Line Therapy in Participants With Hepatocellular Carcinoma

Completed Phase 1, PHASE2 Results posted Last updated 12 May 2021

What this trial tests

Phase 1, PHASE2 trial testing Sorafenib in Hepatocellular Carcinoma in 102 participants. Completed in 23 June 2015.

Timeline

19 July 2011

Primary endpoint
23 June 2015

23 June 2015

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	19 July 2011
Primary completion	23 June 2015
Estimated completion	23 June 2015
Sites	24 locations across Italy, Ukraine, Belgium, United Kingdom, United States, Spain

Drugs / interventions tested

Sorafenib (SORAFENIB) — full drug profile →
Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Eisai Inc. — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT) Primary · 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).

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	1
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	2

Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day -7 Primary · Day -7: 0-72 hours post-dose

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	1330	± 858
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	2320	± 2720

Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1 Primary · Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	1820	± 750
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	2820	± 3170

Phase 1b: Cmax: Maximum Observed Plasma Concentration for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1 Primary · Cycle 1 Day 28: 0-24 hours post-dose

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	2140	± 757
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	4570	± 3610

Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day -7 Primary · Day -7: 0-72 hours post-dose

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	2	1.03 – 24.3
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	2.38	1 – 4

Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 1 Cycle 1 Primary · Cycle 1 Day 1: 0-24 hours post-dose (Cycle length is 28 days)

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	3	2 – 23.8
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	3.53	2 – 24

Phase 1b: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered in Combination With Sorafenib at Day 28 Cycle 1 Primary · Cycle 1 Day 28: 0-24 hours post-dose

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	2.98	1.08 – 4.03
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	5.01	0.833 – 23.5

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 Primary · Day -7: 0-72 hours post-dose

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	30400	± 18900
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	47200	± 37500

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	24000	± 14300
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	36800	± 38000

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	35300	± 16700
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	68700	± 72500

Phase 1b: t1/2: Terminal Elimination Half-life for Golvatinib When Administered in Combination With Sorafenib at Day -7 Primary · Day -7: 0-72 hours post-dose

Group	Value	95% CI
Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg	38.1	± 6.82
Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg	35.9	± 11.7

Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · From first dose of study drug up to 30 days after last dose of study drug (up to approximately 3 years 11 months)

TEAEs

Group	Value	95% CI
Phase 2: Golvatinib 200 mg + Sorafenib 400 mg	42
Phase 2: Sorafenib 400 mg	40

SAEs

Group	Value	95% CI
Phase 2: Golvatinib 200 mg + Sorafenib 400 mg	20
Phase 2: Sorafenib 400 mg	17

Adverse events — posted to ClinicalTrials.gov

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). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1b: Golvatinib 200 mg + Sorafenib 400 mg

Serious: 4/7 (57%)

Deaths: 7/7

Phase 1b: Golvatinib 300 mg + Sorafenib 400 mg

Serious: 3/7 (43%)

Deaths: 6/7

Phase 2: Golvatinib 200 mg + Sorafenib 400 mg

Serious: 20/42 (48%)

Deaths: 32/42

Phase 2: Sorafenib 400 mg

Serious: 17/42 (40%)

Deaths: 32/42

Serious adverse events (57 terms)

Reaction	System	Phase 1b: Golvatinib 200 m…	Phase 1b: Golvatinib 300 m…	Phase 2: Golvatinib 200 mg…	Phase 2: Sorafenib 400 mg
Abdominal Pain	Gastrointestinal disorders	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Gastric Ulcer	Gastrointestinal disorders	—	—	—	—
Hepatic Failure	Hepatobiliary disorders	—	—	—	—
Hepatic Encephalopathy	Nervous system disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Transaminases Increased	Investigations	—	—	—	—
Metabolic Encephalopathy	Nervous system disorders	—	—	—	—
Confusional State	Psychiatric disorders	—	—	—	—
Nephropathy Toxic	Renal and urinary disorders	—	—	—	—
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	—	—	—	—
Dermatitis Psoriasiform	Skin and subcutaneous tissue disorders	—	—	—	—
Febrile Neutropenia	Blood and lymphatic system disorders	—	—	—	—
Cardiac Arrest	Cardiac disorders	—	—	—	—
Abdominal Distension	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Diverticular Perforation	Gastrointestinal disorders	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—

Other adverse events (276 terms — click to expand)

Reaction	System	Phase 1b: Golvatinib 200 m…	Phase 1b: Golvatinib 300 m…	Phase 2: Golvatinib 200 mg…	Phase 2: Sorafenib 400 mg
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	—	—	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Blood Alkaline Phosphatase Increased	Investigations	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Lipase Increased	Investigations	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Weight Decreased	Investigations	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Oedema Peripheral	General disorders	—	—	—	—
Blood Bilirubin Increased	Investigations	—	—	—	—
Pain In Extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Amylase Increased	Investigations	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—

Most-reported serious reactions: Abdominal Pain, Sepsis, Anaemia, Gastric Ulcer, Hepatic Failure, Hepatic Encephalopathy, Nausea, Vomiting.

Data from ClinicalTrials.gov NCT01271504 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent developments of c-Met as a therapeutic target in hepatocellular carcinoma.
Bouattour M, Raymond E, Qin S, Cheng AL, et al · · 2018 · cited 199× · PMID 28862760 · DOI 10.1002/hep.29496
Targeting the HGF/Met signaling pathway in cancer therapy.
Cecchi F, Rabe DC, Bottaro DP. · · 2012 · cited 180× · PMID 22530990 · DOI 10.1517/14728222.2012.680957
Mechanisms of resistance to sorafenib and the corresponding strategies in hepatocellular carcinoma.
Zhai B, Sun XY. · · 2013 · cited 148× · PMID 23898367 · DOI 10.4254/wjh.v5.i7.345
Small molecule inhibitors targeting the cancers.
Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
Targeting the HGF-cMET Axis in Hepatocellular Carcinoma.
Venepalli NK, Goff L. · · 2013 · cited 52× · PMID 23606971 · DOI 10.1155/2013/341636
MET inhibitors for treatment of advanced hepatocellular carcinoma: A review.
Qi XS, Guo XZ, Han GH, Li HY, et al · · 2015 · cited 49× · PMID 25987766 · DOI 10.3748/wjg.v21.i18.5445
Molecular therapies in hepatocellular carcinoma: what can we target?
Galuppo R, Ramaiah D, Ponte OM, Gedaly R. · · 2014 · cited 37× · PMID 24573715 · DOI 10.1007/s10620-014-3058-x
Treating hepatocellular carcinoma progression following first-line sorafenib: therapeutic options and clinical observations.
He AR, Goldenberg AS. · · 2013 · cited 24× · PMID 24179481 · DOI 10.1177/1756283x13498540

Verify or expand the search:

Other trials of Sorafenib

Trials testing the same drug.

NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
NCT06474663 — A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabi · Phase 1 · withdrawn
NCT06690697 — Combination of Toripalimab and JS004 Therapy for ccRCC · Phase 2 · recruiting
NCT06177496 — Influence of Sarcopenia in Hepatocellular Carcinoma Patients · unknown
NCT05033522 — Immunotherapy for Advanced Liver Cancer · Phase 2, PHASE3 · suspended

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting

Other Eisai Inc. trials

Trials by the same sponsor.

NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01271504 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 12 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01271504.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing