check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

11849

ClinicalTrials.gov Identifier:

NCT00492752

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
226
Trial Dates
October 2005 - July 2009
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sun Yat-sen University Cancer CenterGuangzhou, 510060, China
Completed
PLA 81 HospitalNanjing, 210003, China
Completed
Southwest Hospital of 3rd Military Medical University.Chongqing, 400038, China
Completed
Sir Run Run Shaw HospitalHangzhou, 310016, China
Completed
Tongji Hosp. of Huazhong Univ. of Science & TechnologyWuhan, 430030, China
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
National Taiwan University HospitalTaipei, 10016, Taiwan
Completed
Chang-Guang Memorial HospitalTaoyuan, 333, Taiwan
Completed
Nanfang Hospital.Guangzhou, 510515, China
Completed
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, 100021, China
Completed
Affiliated Hospital of Academy of Military Medical Sciences,Beijing, 100039, China
Completed
1st Affiliate Hosp., Dalian Med Univ.Dalian, 116011, China
Completed
2nd affiliate hospital of Dalian medical university.Dalian, 116027, China
Completed
Tianjin Medical University Cancer HospitalTianjin, China
Completed
Cancer Hospital of Jiangsu ProvinceNanjing, 210009, China
Completed
Shanghai Changzheng HospitalShanghai, 200003, China
Completed
Zhongshan Hospital Fudan UniversityShanghai, 200032, China
Completed
1st Affiliate Hospital of Anhui Medical UniversityHefei, 230022, China
Completed
Korea University Guro HospitalSeoul, 152-703, Korea, Republic Of
Completed
Kyungpook National University HospitalDaegu, 702-701, Korea, Republic Of
Completed
Veterans General HospitalTaipei, 251, Taiwan
Completed
Changhua Christian HospitalChanghua, 500, Taiwan
Completed
Chi-Mei Medical Center, LiouyineTainan, 736, Taiwan

Primary Outcome

  • Overall Survival
    date_rangeTime Frame:
    From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Time to Symptomatic Progression (TTSP)
    date_rangeTime Frame:
    From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
    enhanced_encryption
    Safety Issue:
    no
  • Time to Progression (TTP)
    date_rangeTime Frame:
    From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
    enhanced_encryption
    Safety Issue:
    no
  • Disease Control
    date_rangeTime Frame:
    From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
    enhanced_encryption
    Safety Issue:
    no
  • Change in Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) score from baseline to cycle 1 and cycle 3
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    no
  • Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score from baseline to cycle 3 and end of treatment
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    no
  • Number of participants with different Tumor Response
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    no
  • Duration of Response
    date_rangeTime Frame:
    From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
    enhanced_encryption
    Safety Issue:
    no
  • Time to Response
    date_rangeTime Frame:
    From randomization of the first subject until the data cut-off date approximately 23 months after start of randomization
    enhanced_encryption
    Safety Issue:
    No
  • Area under the curve from time 0 to 12 hours post-dose (AUC 0-12) after 21 days of Sorafenib treatment
    date_rangeTime Frame:
    PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
    enhanced_encryption
    Safety Issue:
    no
  • Normalized Area under the curve (AUC norm) after 21 days of Sorafenib treatment
    date_rangeTime Frame:
    PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Maximum concentration (Cmax) after 21 days of Sorafenib treatment
    date_rangeTime Frame:
    PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Normalized maximum concentration (Cmaxnorm) after 21 days of Sorafenib treatment
    date_rangeTime Frame:
    PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
    enhanced_encryption
    Safety Issue:
    No
  • Time of maximum concentration (Tmax) after 21 days of Sorafenib treatment
    date_rangeTime Frame:
    PK assessments made at following times: pre-dose, 1 h, 2h, 4h, 8h,and 12h after at least 21 consecutive doses during Cycle 1
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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