Trial Condition(s):
Carcinoma, Hepatocellular
A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Bayer Identifier:
11849
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of the study is
- Find out if patients receiving Sorafenib will live longer
- Find out if Sorafenib has any effect on patient reported outcomes
- Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their metastases
- Determine the pharmacokinetics (PK) in patients with liver cancer
Inclusion Criteria
- Ages eligible for study: 18 years and above, Genders eligible for study: both - Patients who have a life expectancy of at least 12 weeks - Patients with advanced Hepatocellular carcinoma (HCC) (unresectable, and/or metastatic) which has been histologically or cytologically documented - Patients must have at least one tumor lesion that meets both of the following criteria (1) Accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST) (2) Not been previously treated with local therapy - 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 - Patients who have an Eastern Co-operative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Exclusion Criteria
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]&T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted - History of cardiac disease - Active clinically serious infections - Known history of human immunodeficiency virus (HIV) infection - Known central nervous system (CNS) tumors including metastatic brain disease - Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PLA 81 Hospital Nanjing, China, 210003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southwest Hospital of 3rd Military Medical University. Chongqing, China, 400038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Run Run Shaw Hospital Hangzhou, China, 310016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tongji Hosp. of Huazhong Univ. of Science & Technology Wuhan, China, 430030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang-Guang Memorial Hospital Taoyuan, Taiwan, China, 333 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nanfang Hospital. Guangzhou, China, 510515 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Hospital, Chinese Academy of Medical Sciences Beijing, China, 100021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China, 100039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliate Hosp., Dalian Med Univ. Dalian, China, 116011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 2nd affiliate hospital of Dalian medical university. Dalian, China, 116027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tianjin Medical University Cancer Hospital Tianjin, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Hospital of Jiangsu Province Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Changzheng Hospital Shanghai, China, 200003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhongshan Hospital Fudan University Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliate Hospital of Anhui Medical University Hefei , China, 230022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Korea University Guro Hospital Seoul, South Korea, 152-703 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyungpook National University Hospital Daegu, South Korea, 702-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans General Hospital Taipei, Taiwan, China, 251 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chi-Mei Medical Center, Liouyine Tainan, Taiwan, China, 736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blinded, placebo-controlled study of sorafenib in patients with advanced hepatocellular carcinoma
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall SurvivalTimeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
Secondary Outcome
- Time to Symptomatic Progression (TTSP)Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- Time to Progression (TTP)Timeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- Disease ControlTimeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) score from baseline to cycle 1 and cycle 3Timeframe: Baseline up to Cycle 1 and Cycle 3. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score from baseline to cycle 3 and end of treatmentTimeframe: Baseline up to Cycle 3 and end of treatment. From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- Number of participants with different Tumor ResponseTimeframe: From randomization/start of treatment of the first subject until approximately 23 months after randomization when the subjects on placebo were offered the option to crossover to Sorafenib treatment
- Duration of ResponseTimeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- Time to ResponseTimeframe: From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
- Area under the curve from time 0 to 12 hours post-dose (AUC 0-12) after 21 days of Sorafenib treatmentTimeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
- Normalized Area under the curve (AUC norm) after 21 days of Sorafenib treatmentTimeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
- Maximum concentration (Cmax) after 21 days of Sorafenib treatmentTimeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
- Normalized maximum concentration (Cmaxnorm) after 21 days of Sorafenib treatmentTimeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
- Time of maximum concentration (Tmax) after 21 days of Sorafenib treatmentTimeframe: PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
Additional Information
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