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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01232296
First received: September 30, 2010
Last updated: February 10, 2014
Last verified: February 2014

September 30, 2010
February 10, 2014
July 2011
April 2014   (final data collection date for primary outcome measure)
Overall Survival - Overall survival [ Time Frame: Every 6 weeks after disease progression ] [ Designated as safety issue: Yes ]
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 after disease progression ] [ Designated as safety issue: No ]
  • Disease Control Rate (Tumor assessment) [ 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 ]
  • Pharmacokinetcs drug Plasma concentration and Pharmacokinetics (PK)sub-parameters for TKI258 patients [ Time Frame: Week 3 only, and as clinically indicated ] [ Designated as safety issue: Yes ]
  • 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: Single Group 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.
 
Active, not recruiting
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
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Japan,   Korea, Republic of,   Singapore,   Taiwan,   Thailand
 
NCT01232296
CTKI258A2208
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2014

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