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

NCT ID: NCT01232296

Last Updated: 2015-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TKI258

capsule

Group Type EXPERIMENTAL

dovitinib

Intervention Type DRUG

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

Sorafenib

tablet

Group Type EXPERIMENTAL

sorafenib

Intervention Type DRUG

400 mg p.o. b.i.d.

Interventions

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dovitinib

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

Intervention Type DRUG

sorafenib

400 mg p.o. b.i.d.

Intervention Type DRUG

Other Intervention Names

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TKI258

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nanjing, Jiangsu, China

Site Status

Novartis Investigative Site

Xi’an, Shanxi, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Shatin, New Territories, Hong Kong, Hong Kong

Site Status

Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Sayama, Osaka, Japan

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Taichung, Taiwan, Taiwan

Site Status

Novartis Investigative Site

Taipei, Taiwan, Taiwan

Site Status

Novartis Investigative Site

Taipei, Taiwan, ROC, Taiwan

Site Status

Novartis Investigative Site

Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Chiang Mai, , Thailand

Site Status

Novartis Investigative Site

Khon Kaen, , Thailand

Site Status

Novartis Investigative Site

Songkhla, , Thailand

Site Status

Countries

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China Hong Kong Japan Singapore South Korea Taiwan Thailand

Other Identifiers

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CTKI258A2208

Identifier Type: -

Identifier Source: org_study_id