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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01232296
First received: September 30, 2010
Last updated: November 2, 2015
Last verified: November 2015
Results First Received: March 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Interventions: Drug: dovitinib
Drug: sorafenib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
165 Participants were screened and randomized. However 3 participants discontinued prior to recieving study drug. The number enrolled in the protocol section reflects the randomized participants who received study drug.

Reporting Groups
  Description
TKI258 500 mg capsules p.o. o.d. 5 days on/2 days off
Sorafenib 400 mg tablet p.o. b.i.d.

Participant Flow:   Overall Study
    TKI258     Sorafenib  
STARTED     82     83  
Full Analysis Set     82     83  
Safety Set     79 [1]   83  
COMPLETED     0     0  
NOT COMPLETED     82     83  
Adverse Event                 24                 12  
Physician Decision                 1                 1  
Progressive disease                 43                 61  
Study terminated by sponsor                 0                 1  
Technical problems                 3                 0  
Subject/guardian decision                 10                 2  
Death                 1                 6  
[1] The Safety Set includes all patients who received at least one dose of study medication



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TKI258 500 mg capsules p.o. o.d. 5 days on/2 days off
Sorafenib 400 mg tablet p.o. b.i.d.
Total Total of all reporting groups

Baseline Measures
    TKI258     Sorafenib     Total  
Number of Participants  
[units: participants]
  82     83     165  
Age  
[units: Years]
Mean (Standard Deviation)
  55.5  (12.16)     56.2  (11.72)     55.8  (11.91)  
Gender  
[units: Participants]
     
Female     9     16     25  
Male     73     67     140  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   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. ]

3.  Secondary:   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. ]

4.  Secondary:   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 ]

5.  Secondary:   Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258   [ Time Frame: Week 1 day 1, week 4 day 5 ]

6.  Secondary:   Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258   [ Time Frame: Week 1 day 1, week 4 day 5 ]

7.  Secondary:   Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258   [ Time Frame: Week 1 day 1, week 4 day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01232296     History of Changes
Other Study ID Numbers: CTKI258A2208
Study First Received: September 30, 2010
Results First Received: March 26, 2015
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration
Hong Kong: Department of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Thailand: Food and Drug Administration
Singapore: Health Sciences Authority
China: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Turkey: Ministry of Health