The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Novartis Investigative Site
Nanjing, Jiangsu, China
Overall Survival - Overall Survival
The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed
Time frame: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.
Time to Tumor Progression (Tumor Assessment)
Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). For target lesions, disease progression mean at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression refers to unequivocal progression of existing non-target lesions. In addition, the appearance of new lesions is always considered as disease progression.
Time frame: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.
Disease Control Rate (Tumor Assessment)
Disease Control Rate (DCR) is defined as the proportion of patients whose best overall response is either complete response \[CR\], partial response \[PR\] or stable disease \[SD\] according to RECIST 1.1.
Time frame: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.
Time to Definitive Deterioration in ECOG Performance Status (PS)
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Novartis Investigative Site
Xi’an, Shanxi, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shatin, New Territories, Hong Kong, Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Sayama, Osaka, Japan
Novartis Investigative Site
Singapore, Singapore
...and 14 more locations
Time to definitive deterioration on ECOG PS scale (by at least one point) was defined as the time from the date of randomization to the date of definitive deterioration of the ECOG PS by at least one category of the score from baseline or to the date of death whichever occurred earlier. 0 is Fully active, able to carry on all pre-disease performance without restriction, 1 is Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work and 2 is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time frame: Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first
Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258
Cmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1).
Time frame: Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258
Tmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Tmax is the time to to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (time)
Time frame: Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258
The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)
Time frame: Week 1 day 1, week 4 day 5