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

November 2, 2015 updated by: Novartis Pharmaceuticals

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 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100039
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Novartis Investigative Site
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site
      • Shatin, New Territories, Hong Kong
        • Novartis Investigative Site
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 232-0024
        • Novartis Investigative Site
    • Osaka
      • OsakaSayama, Osaka, Japan, 589-8511
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 136-705
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 03722
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taipei, Taiwan, 10048
        • Novartis Investigative Site
    • Taiwan, ROC
      • Taipei, Taiwan, ROC, Taiwan, 112
        • Novartis Investigative Site
    • Taoyuan/ Taiwan ROC
      • Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan, 33305
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
      • Khon Kaen, Thailand, 40002
        • Novartis Investigative Site
      • Songkla, Thailand, 90110
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TKI258
capsule
Drug: dovitinib
500 mg p.o. o.d. 5 days on/2 days off
Other Names:
  • TKI258
Experimental: Sorafenib
tablet
Drug: sorafenib
400 mg p.o. b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival - Overall Survival
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.
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Tumor Progression (Tumor Assessment)
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 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.
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)
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 (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.
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)
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 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.
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
Time Frame: Week 1 day 1, week 4 day 5
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).
Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258
Time Frame: Week 1 day 1, week 4 day 5
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)
Week 1 day 1, week 4 day 5
Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258
Time Frame: Week 1 day 1, week 4 day 5
The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)
Week 1 day 1, week 4 day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTKI258A2208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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