Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Liver Extracts

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

dovitinib

sorafenib

Novartis Pharmaceuticals

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.

A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment

An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma

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

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.

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 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.

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).

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)

The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)

500 mg capsules p.o. o.d. 5 days on/2 days off

TKI258

Total

Age, Continuous

Sex: Female, Male

Study Director

The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.

Overall Survival - Overall Survival

Time to Tumor Progression (Tumor Assessment)

Complete response (CR)

Partial response (PR)

Stable disease (SD)

Progressive disease

Unknown (UNK)

Disease Control Rate (Tumor Assessment)

The Full Analysis Set (FAS): all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. Only Total number of definitive deterioration events included in the analysis

Time to Definitive Deterioration in ECOG Performance Status (PS)

Week 1 Day 1 (n=71)

Week 4 Day 5 (n=23)

The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment	NCT01232296	Hepatocellular ...	dovitinib sorafenib	18 Years -	Novartis
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment	NCT01232296	Hepatocellular ...	dovitinib sorafenib	18 Years -	Novartis

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