Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Hepatocellular

In brief

The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

Key facts

Study ID

NCT01774344

Run by

Bayer

People needed

573

Starts

2013-05-14

Expected to finish

2019-07-05

Last updated by the study team

2020-08-20

Who can join

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

You may qualify if…

• Histological or cytological confirmation of HCC (hepatocellular carcinoma) or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases criteria in patients with a confirmed diagnosis of cirrhosis
• Barcelona Clinic Liver Cancer stage Category B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, local ablation, chemoembolization or systemic sorafenib.
• Failure to prior treatment with sorafenib (defined as documented radiological progression according to the radiology charter). Randomization needs to be performed within 10 weeks after the last treatment with sorafenib.
• Tolerability of prior treatment with sorafenib defined as not less than 20 days at a minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal.
• Liver function status Child-Pugh Class A. Child Pugh status should be calculated based on clinical findings and laboratory results during the screening period.
• Local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >/=4 weeks before first dose of study medication. Note: patients who received sole intrahepatic intraarterial chemotherapy, without lipiodol or embolizing agents are not eligible.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted within 7 days before randomization.
• Glomerular filtration rate >/= 30 ml/min/1.73 m\^2 according to the Modification of diet in renal disease study equation.
• At least one uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1), and modified RECIST for HCC. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion.
• Life expectancy of at least 3 months.
• Women of childbearing potential and men must agree to use adequate contraception .

You may not qualify if…

• Sorafenib treatment within 2 weeks of randomization.
• Prior systemic treatment for HCC, except sorafenib.
• Permanent discontinuation of prior sorafenib therapy due to sorafenib related toxicity.
• Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
• Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
• Uncontrolled ascites (defined as not easily controlled with diuretic or paracentesis treatment).
• Ongoing infection > Grade 2 according to NCI-CTCAE (National Cancer Institute - Common Terminology Criteria for Adverse Events) v. 4.0. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required.
• Clinically significant bleeding NCI-CTCAE version 4.0 Grade 3 or higher within 30 days before randomization.
• Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication.
• Patients unable to swallow oral medications.
• Interstitial lung disease with ongoing signs and symptoms at the time of screening.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Richmond, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Pilar, Buenos Aires, Argentina
• Study site — Camperdown, New South Wales, Australia
• Study site — Liverpool, New South Wales, Australia
• Study site — Herston, Queensland, Australia
• Study site — Clayton, Victoria, Australia
• Study site — Box Hill, Australia
• Study site — Graz, Styria, Austria
• Study site — Linz, Upper Austria, Austria
• Study site — Los Angeles, California, United States

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.