Clinical trial NCT01232296: A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
HCC
Liver cancer
Child Pugh A
HCC Stage C
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines

* Advance HCC Stage B and C according to BCLC staging classification
* Child Pugh A
* At least one measurable lesion as assessed by CT or MRI
* ECOG PS of 0 or 1
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Prior systemic therapy for HCC
* Brain metastases
* Active bleeding (including variceal bleeding as the result of esophageal varices) Patients who have received a liver transplant or are awaiting an immediate transplant

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Overall Survival - Overall Survival
timeFrame: 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.
Secondary outcomes:
measure: Time to Tumor Progression (Tumor Assessment)
timeFrame: 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.
measure: Disease Control Rate (Tumor Assessment)
timeFrame: 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.
measure: Time to Definitive Deterioration in ECOG Performance Status (PS)
timeFrame: 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
measure: Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258
timeFrame: Week 1 day 1, week 4 day 5
measure: Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258
timeFrame: Week 1 day 1, week 4 day 5
measure: Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258
timeFrame: Week 1 day 1, week 4 day 5
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Shatin, New Territories
country: Hong Kong
facility: Novartis Investigative Site
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: OsakaSayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan, ROC
city: Kuei-Shan Chiang
country: Taiwan
facility: Novartis Investigative Site
state: Taoyuan/ Taiwan ROC
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
city: Songkla
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: