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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

September 30, 2010
November 2, 2015
July 2011
April 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
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
Overall Survival [ Time Frame: Every 6 weeks after disease progression ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01232296 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    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 (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. ] [ Designated as safety issue: Yes ]
    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 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 ] [ Designated as safety issue: No ]
    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.
  • Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258 [ Time Frame: Week 1 day 1, week 4 day 5 ] [ Designated as safety issue: Yes ]
    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).
  • Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258 [ Time Frame: Week 1 day 1, week 4 day 5 ] [ Designated as safety issue: Yes ]
    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)
  • Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258 [ Time Frame: Week 1 day 1, week 4 day 5 ] [ Designated as safety issue: Yes ]
    The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)
  • Time to Tumor Progression [ Time Frame: Every 6 weeks after disease progression ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: Every 6 weeks after disease progression ] [ Designated as safety issue: Yes ]
  • Time to definitive deterioration in ECOG performance status (PS) [ Time Frame: Every 6 weeks after disease progression ] [ Designated as safety issue: No ]
  • Safety and Tolerability - Incidence of Adverse Event (AE), Serious Adverse Events (SAE), and lab results [ Time Frame: Every 6 weeks until End of Treatment ] [ Designated as safety issue: Yes ]
  • Plasma concentration and Pharmacokinetics (PK)sub-parameters for all patients randomized to TKI258 [ Time Frame: Week 3 only, and as clinically indicated ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: dovitinib
    500 mg p.o. o.d. 5 days on/2 days off
    Other Name: TKI258
  • Drug: sorafenib
    400 mg p.o. b.i.d.
  • Experimental: TKI258
    capsule
    Intervention: Drug: dovitinib
  • Experimental: Sorafenib
    tablet
    Intervention: Drug: sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
April 2014
April 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Japan,   Korea, Republic of,   Singapore,   Taiwan,   Thailand
Turkey
 
NCT01232296
CTKI258A2208
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP