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

Completed · Phase 1/Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT01271504

Run by

Eisai Inc.

People needed

102

Starts

2011-07-19

Expected to finish

2015-06-23

Last updated by the study team

2021-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Fort Myers, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Brussels, Belgium
• Study site — Brussels, Belgium
• Study site — Leuven, Belgium
• Study site — Rozzano, Milano, Italy
• Study site — Modena, Italy
• Study site — Pavia, Italy
• Study site — Madrid, Spain
• Study site — Madrid, Spain
• Study site — Madrid, Spain
• Study site — Madrid, Spain
• Study site — Dnipropetrovsk, Ukraine
• Study site — Donetsk, Ukraine
• Study site — Kharkiv, Ukraine
• Study site — Lviv, Ukraine
• Study site — London, Greater London, United Kingdom
• Study site — Manchester, Greater Manchester, United Kingdom
• Study site — Glasgow, Strathclyde, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.