CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer
NCT ID: NCT01033240
Last Updated: 2021-04-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2010-07-09
2013-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Surufatinib Alone or Combined With Anti-PD-1 mAb in the Treatment of Advanced Hepatocellular Carcinoma
NCT05282433
SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma
NCT04560894
MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma
NCT02575339
Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
NCT01932385
Dose Escalation of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
NCT00490685
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Safety Cohort 1 CS-1008 and Sorafenib
Combination of CS-1008 and sorafenib; CS-1008 (2 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression.
CS-1008 2 mg/kg
On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg.
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
Safety Cohort 2 CS-1008 and Sorafenib
Combination of CS-1008 and sorafenib; CS-1008 (4 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression.
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
CS-1008 4 mg/kg
On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated.
Safety Cohort 3 CS-1008 and Sorafenib
Combination of CS-1008 and sorafenib; CS-1008 (6 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression.
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
CS-1008 6 mg/kg
On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.
Treatment Group 1 CS-1008 and Sorafenib
Combination of CS-1008 and sorafenib. Treatment Group 1: CS-1008 (6 mg/kg \[or as determined\] loading, 2 mg/kg/week maintenance) + sorafenib twice daily (N=50)
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
CS-1008 6/2 mg/kg
A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis.
Treatment Group 2 with CS-1008 and Sorafenib
Combination of CS-1008 and sorafenib. Treatment Group 2: CS-1008 (6 mg/kg \[or as determined\] loading, 6 mg/kg/week \[or maximum tolerated dose {MTD}\] maintenance) + sorafenib twice daily (N=50)
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
CS-1008 6/6 mg/kg
A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis.
Treatment Group 3 with Sorafenib Alone
Sorafenib. Treatment Group 3: sorafenib twice daily (N=50)
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CS-1008 2 mg/kg
On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg.
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
CS-1008 6/2 mg/kg
A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis.
CS-1008 6/6 mg/kg
A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis.
CS-1008 4 mg/kg
On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated.
CS-1008 6 mg/kg
On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* History of chronic hepatitis and/or cirrhosis of liver;
* Typical features of HCC demonstrated in dynamic imaging studies, such as three-phase computed tomography (CT); AND
* Alpha-fetoprotein (AFP) level \> 200 ng/mL
* Advanced diseases
* Extrahepatic metastasis, OR
* Locally advanced diseases which are not amenable for surgical resection or other loco-regional therapies including transhepatic arterial (chemo) embolization (TACE or TAE) and local ablative therapy
* Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of at least 1 untreated target lesion that can be measured in 1 dimension
* At least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Child-Pugh class A
* Life expectancy of at least 12 weeks
* Adequate organ and bone marrow function as assessed by clinical laboratory evaluations:
* Hemoglobin ≥ 8.5 g/dL (transfusion and/or growth factor support allowed)
* Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
* Platelet count ≥ 75 x 10\^9/L
* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance \> 40 mL/min
* Aspartate Aminotransferase (AST) and alkaline phosphatase ≤ 5.0 x ULN
* Total bilirubin ≤ 1.5 x ULN
* Serum amylase and lipase ≤ 1.5 x ULN
* Women of childbearing potential must be willing to consent to using effective contraception (eg, abstinence, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for 3 months thereafter. Men who are the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter
* All female participants of childbearing potential must have a negative pregnancy test (serum or urine) result
* Participants must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an International Review Board (IRB)/ Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before the performance of any study specific procedures or tests
* Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria
* Radiotherapy or major surgical procedure within 4 weeks of the screening/baseline visit or minor surgical procedures (eg, core biopsy or fine needle aspiration) within 2 weeks of the screening/baseline visit
* Anticipation of need for radiotherapy (RT) or a major surgical procedure during the study
* Any investigational agent within 4 weeks before the screening/baseline visit
* History of any of the following conditions within 6 months before the screening/baseline visit:
* Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 30%)
* Severe/unstable angina pectoris
* New York Heart Association (NYHA) class III or intravenous (IV) congestive heart failure
* Clinically significant pulmonary disease (eg, severe chronic obstructive pulmonary disease or asthma)
* Clinically active brain metastases (defined as untreated, symptomatic or requiring steroids or anticonvulsants medications to control associated symptoms), uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Participants with treated brain metastasis will be included in the study if they have recovered from the acute, toxic effects of radiotherapy. A minimum of 15 days must have elapsed between the end of RT and the screening/baseline visit
* History of organ transplantation
* Clinically significant, severe, active infection requiring IV antibiotics
* Known history of human immunodeficiency virus (HIV) infection
* History of prior sensitivity reaction to any components of CS-1008 or sorafenib formulations
* History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
* Pregnant or breast feeding
* Serious intercurrent medical illnesses that, in the opinion of the Investigator, would impair the participant's ability to provide informed consent or unacceptably reduce the safety of the proposed treatment
* Clinically significant (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] grade ≥ 3) gastrointestinal bleeding in the past 12 months or current active gastrointestinal bleeding
* Presence of esophageal varices at risk of bleeding, such as large esophageal/gastric varices or those with red sign, or active peptic ulcer with or without exposed vessels at risk of bleeding (as documented by endoscopy)
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 6 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daiichi Sankyo
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kenmar Research Group
Los Angeles, California, United States
Georgetown-Lombardi Cancer Center
Washington D.C., District of Columbia, United States
The Mount Sinai Medical Center
New York, New York, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Hiroshima University
Hiroshima, Hiroshima, Japan
Kanazawa University
Kanazawa, Ishikawa-ken, Japan
Kinki University Hospital
Osaka, Osaka-sayama, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Chiba University Hospital
Chiba, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka Med Center Cancer and Cardiovascular Disease
Osaka, , Japan
Musashino Red-Cross Hospital
Tokyo, , Japan
Keimyung University Dongsan Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Catholic Univ. of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kaohiung Chang Gung Hospital
Kaohsiung City, Niaosung Hsiang, Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital
Chiayi City, , Taiwan
Kaohslung Medical University Hospital
Kaohsiung City, , Taiwan
National Cheng-Kung University Hospital
Tainan City, , Taiwan
Chi-Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkuo
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cheng AL, Kang YK, He AR, Lim HY, Ryoo BY, Hung CH, Sheen IS, Izumi N, Austin T, Wang Q, Greenberg J, Shiratori S, Beckman RA, Kudo M; Investigators' Study Group. Safety and efficacy of tigatuzumab plus sorafenib as first-line therapy in subjects with advanced hepatocellular carcinoma: A phase 2 randomized study. J Hepatol. 2015 Oct;63(4):896-904. doi: 10.1016/j.jhep.2015.06.001. Epub 2015 Jun 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CS1008-A-U204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.