check_circleStudy Completed
Hepatocellular Carcinoma
Bayer Identifier:
14898
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Hepatocellular Carcinoma – Advanced Stage – Sorafenib Trial in Taiwanese Patients
Trial purpose
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.
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
151Trial Dates
August 2010 - October 2013Phase
Phase 4Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Taoyuan, 33305, Taiwan | |
Completed | Taichung City, 40447, Taiwan | |
Completed | Chia Yi, 613, Taiwan | |
Completed | Kaohsiung City, 807, Taiwan | |
Completed | Kaohsiung City, 8330, Taiwan | |
Completed | Taipei City,, Taiwan | |
Completed | Hualien county, 970, Taiwan |
Primary Outcome
- Time to progressiondate_rangeTime Frame:30 monthsenhanced_encryptionNoSafety Issue:
- Progression-free survivaldate_rangeTime Frame:30 monthsenhanced_encryptionNoSafety Issue:
- Overall survivaldate_rangeTime Frame:30 monthsenhanced_encryptionNoSafety Issue:
- Adverse event and serious adverse event (SAE) profilesdate_rangeTime Frame:30 monthsenhanced_encryptionYesSafety Issue:
- Child-Pugh status progressiondate_rangeTime Frame:30 monthsenhanced_encryptionYesSafety Issue:
- Plasma Sorafenib exposure (AUC0-12)date_rangeTime Frame:30 monthsenhanced_encryptionNoSafety Issue:
- For subjects randomized into HFSR study subgroup: overall HFSR incidence in the first 3 weeks of Sorafenib treatmentdate_rangeTime Frame:18 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- For HFSR study subgroup: a mean HFSR grade determined at the end of the first 3 weeks of sorafenib treatment.date_rangeTime Frame:18 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1