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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
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: dovitinib
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall Survival - Overall survival [ Time Frame: Every 6 weeks after disease progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 162
Study Start Date: July 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258
capsule
Drug: dovitinib
500 mg p.o. o.d. 5 days on/2 days off
Other Name: TKI258
Experimental: Sorafenib
tablet
Drug: sorafenib
400 mg p.o. b.i.d.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232296

Locations
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210002
China, Shanxi
Novartis Investigative Site
Xi'an, Shanxi, China, 710032
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310016
China
Novartis Investigative Site
Beijing, China, 100039
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Shatin, New Territories, Hong Kong
Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 232-0024
Novartis Investigative Site
OsakaSayama, Osaka, Japan, 589-8511
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site
Seoul, Korea, Republic of, 738-736
Novartis Investigative Site
Seoul, Korea, Republic of, 136 705
Singapore
Novartis Investigative Site
Singapore, Singapore, 308433
Taiwan
Novartis Investigative Site
Taipei, Taiwan, ROC, Taiwan, 112
Novartis Investigative Site
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan, 33305
Novartis Investigative Site
Taichung, Taiwan, 40705
Novartis Investigative Site
Taipei, Taiwan, 10048
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Bangkok, Thailand, 10330
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Novartis Investigative Site
Khon Kaen, Thailand, 40002
Novartis Investigative Site
Songkla, Thailand, 90110
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

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
Last Updated: February 10, 2014
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

Keywords provided by Novartis:
Hepatocellular Carcinoma
HCC
Liver cancer
Child Pugh A
HCC Stage C

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014