Hepatocellular carcinoma, in patients who have failed (experienced radiological progression) previous treatment cancer MedDRA version: 14.0 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Bay 73-4506
Pharmaceutical Form: Tablet
INN or Proposed INN: Regorafenib
CAS Number: 755037-03-7
Current Sponsor code: Bay 73-4506
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Bayer HealthCare AG, D51368 Leverkusen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Male or female patients aged equal or above18 years. *Histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per AASLD criteria. *BCLC stage Category A, B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib. *Liver function status Child-Pugh class A. *Failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy) *Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of BAY 73-4506. *Recovery from any previous drug/procedure-related toxicity to CTC Grade 0 or 1 levels (except alopecia), or to baseline preceding the prior treatment. *ECOG PS of 0 or 1. *Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted (Modified diet in renal disease) abbreviated formula *At least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to Response Evaluation Criteria (RECIST) and JNCI amendments regarding characterization of lesions in HCC *Life expectancy of at least 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: *Prior treatment with BAY 73-4506. *Esophageal varices at risk of bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of esophageal varices should be performed by endoscopy within 6 months of study start, and within 12 months for patients in whom conventional medical intervention for known esophageal varices is already in place. *Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed. *Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or basal cell epithelioma. Any cancer curatively treated > 5 years prior to study entry is permitted. *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). *Major surgical procedure or significant traumatic injury within 28 days before start of study medication. *Pregnant or breast-feeding patients. *Congestive heart failure NYHA>= class 2 *Unstable angina (angina symptoms at rest, new –onset angina ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication. *Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). *Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management). *Patients with phaeochromocytoma. *Ongoing infection > Grade 2 NCI-CTC version 3.0. *Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hours, measured by urine protein/creatinine ratio on a random urine sample). *Clinically significant bleeding within 30 days before start of study medication. *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 treatment. *Dehydration NCI-CTC version 3.0 Grade = 1. *Unresolved toxicity higher than NCI-CTCAE (version 3.0) Grade 1 (excluding alopecia) attributed to any prior therapy/procedure. *Any illness or medical condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study. *Known history of human immunodeficiency virus (HIV) infection. *Patients with seizure disorder requiring medication. *History of organ allograft. *Non-healing wound, ulcer, or bone fracture. *Renal failure requiring hemo-or peritoneal dialysis. *Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. *Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. *Patients unable to swallow oral medications. *Interstitial lung disease with ongoing signs and symptoms at the time of screening. *Any malabsorption condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety profile of BAY 73-4506 in patients with hepatocellular carcinoma (HCC).;Secondary Objective: Efficacy, as assessed by Time to progression (TTP), Objective response rate (ORR) disease control rate (DCR), Overall survival (OS) and Pharmacokinetics ;Primary end point(s): Safety ;Timepoint(s) of evaluation of this end point: ongoing in the study and at the end | — |
Countries
Germany, Italy, Korea, Republic of, Spain
Contacts
Public ContactCTP Team/ Ref:" EU CTR"/
Bayer HealthCare AG
Outcome results
None listed