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Phase 2, Randomized study of CS-1008 in combination with Sorafenib compared to Sorafenib alone as first-line systemic therapy in subjects with advanced hepatocellular carcinoma

DAIICHI SANKYO Co.,Ltd.

http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html

Interventional

multicenter, open-label, randomized study

2

Histologically or cytologically confirmed HCC OR clinical diagnosis of HCC when the following criteria (a + b or a+c) are met:
a. History of chronic hepatitis and/or cirrhosis of liver
b. Typical features of HCC demonstrated in dynamic imaging studies, such as three-phase computed tomography (CT)
c. Hepatic tumor (>2 cm) with atypical imaging and alpha-fetoprotein (AFP) level >200 ng/mL

Advanced disease
- Patients who have received previous local therapy for HCC are eligible for enrollment in the study, provided either
1) at least one lesion measurable by RECIST criteria (version 1.1) prior to treatment with local therapy has increased by 25% or more in longest diameter following local therapy, or
2) at least one measurable lesion has not been treated with local therapy AND the patient also has at least one extrahepatic metastasis.
OR
- Patients with locally advanced disease not amenable to surgical resection or other loco-regional therapies, including transhepatic arterial (chemo) embolization (TACE or TAE) and local ablative therapy, are eligible.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Child-Pugh class A

At least 18 years of age (Japan: At least 20 years of age )

Any prior systemic therapy for HCC, including systemic chemotherapy (prior exposure to chemotherapy by TACE is allowed if stopped at least 4 weeks before the first dose of study treatment), immunotherapy, sorafenib or other Raf kinase inhibitors, VEGF/VEGFR-inhibitors, epidermal growth factor receptor inhibitors or mTOR inhibitors.

Radiotherapy (RT) or major surgical procedure within 4 weeks of the first dose of study treatment or minor surgical procedures (eg, core biopsy or fine needle aspiration) within 2 weeks of the first dose of the study treatment.

Any investigational agent within 4 weeks before the first dose of the study treatment.

Both

Advanced hepatocellular carcinoma

investigational material(s)
Generic name etc : tigatuzumab (CS-1008)
INN of investigational material : tigatuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : intravenous infusion

Time to progression (TTP)
RECIST (v1.1)

Objective response rate (ORR), Overall survival (OS), Safety, Pharmacokinetic (PK), Biomarker study
RECIST (v1.1), NCI CTCAE (v4.0)