Hepatocellular Carcinoma - Advanced Stage - Sorafenib Trial in Taiwanese Patients

NCT01098760 | Completed Phase 4

• 2 other identifiers: 14898HATT
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 7

Brief Summary

This is a single-arm, open-label and post-authorization study to evaluate the safety and efficacy profile of sorafenib and to evaluate Child-Pugh status progression in subjects with advanced HCC treated with sorafenib in Taiwan. In a subgroup of patients (hand-foot skin reaction (HFSR) study subgroup), this study also aims to test if topical corticosteroids as preventive counter-measure applied to hands and feet for the first 3 weeks during sorafenib treatment reduce incidence and severity of HFSR compared to a matching, corticosteroid-free cosmetic ointment, measured over the first 3 and 6 weeks of sorafenib treatment.

Conditions

Hepatocellular Carcinoma

Keywords

Sorafenib; Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (7)

• Time to progression

  30 months

• Progression-free survival

  30 months

• Overall survival

  30 months

• Adverse event and serious adverse event (SAE) profiles

  30 months

• Child-Pugh status progression

  30 months

• Plasma Sorafenib exposure (AUC0-12)

  30 months

• For subjects randomized into HFSR study subgroup: overall HFSR incidence in the first 3 weeks of Sorafenib treatment

  18 months

Secondary Outcomes (1)

• For HFSR study subgroup: a mean HFSR grade determined at the end of the first 3 weeks of sorafenib treatment.

  18 months

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment

Interventions

Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment DRUG

Orally taken Sorafenib tablets of 400mg (2x200mg) twice daily (bid) in a continuous schedule. - For patients in Nerisone subgroup: additionally prophylactic use of Nerisone Fatty Ointment (1 g of Nerisone contains 1 mg (0.1%) diflucortolone valerate) cream for hands and feet, twice daily for 3 weeks - For patients in Neribas subgroup: additionally prophylactic use of Neribas Fatty Ointment (non-corticosteroid containing) cream for hands and feet, twice daily for 3 weeks

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Disease (AASLD) criteria in cirrhotic patients is required. For subjects without cirrhosis, histological or cytological confirmation is mandatory.
• Unresectable advanced/or metastatic HCC not amenable to local treatment modalities
• Patients must have at least one tumor lesion that meets both of the following criteria:
• The lesion can be accurately measured in at least one dimension according to RECIST amendment (version 1.0)
• The lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation).
• Patients who have received local therapy such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan.
• Cirrhotic status of Child-Pugh Class A. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period.
• Male or female patients \>/= 18 years of age
• Patients who have a life expectancy of at least 12 weeks
• Patients who have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0,1 or 2
• Resolution of all acute toxic effects of any prior local treatment to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 grade \</= 1
• The following laboratory parameters:
• Platelet count \>/= 60 x 10\^9/L
• Hemoglobin \>/= 8.5 g/dL
• Total bilirubin \</= 2.8 mg/dL

You may not qualify if:

• Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis \&T1). Any cancer curatively treated \> 3 years prior to entry is permitted.
• Renal failure requiring hemo- or peritoneal dialysis.
• History of cardiac disease:
• Congestive heart failure \> New York Heart Association (NYHA) class 2
• Active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than β-blockers or digoxin)
• Uncontrolled hypertension, defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg despite optimal medical management.
• Active, clinically serious infections (\> grade 2 NCI-CTCAE, version 4.0), except HBV/HCV infections
• Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness or serious acute or chronic illness
• Known central nervous system tumors, including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• History of organ allograft
• Child-Pugh Class B or C
• Previous treatment with yttrium-90 spheres
• Clinically significant (ie, symptomatic) peripheral vascular disease

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Chiayi City, 613, Taiwan

Location

Unknown Facility

Hualien County, 970, Taiwan

Location

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

Kaohsiung City, 8330, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 5, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

TW (7)