NCT01232296

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2011

Geographic Reach
7 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 4, 2015

Completed
Last Updated

December 4, 2015

Status Verified

November 1, 2015

Enrollment Period

2.8 years

First QC Date

September 30, 2010

Results QC Date

March 26, 2015

Last Update Submit

November 2, 2015

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaHCCLiver cancerChild Pugh AHCC Stage C

Outcome Measures

Primary Outcomes (1)

  • Overall Survival - Overall Survival

    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 Outcomes (6)

  • Time to Tumor Progression (Tumor Assessment)

    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)

    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)

    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

    Week 1 day 1, week 4 day 5

  • Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258

    Week 1 day 1, week 4 day 5

  • +1 more secondary outcomes

Study Arms (2)

TKI258

EXPERIMENTAL

capsule

Drug: dovitinib

Sorafenib

EXPERIMENTAL

tablet

Drug: sorafenib

Interventions

dovitinibDRUG

500 mg p.o. o.d. 5 days on/2 days off

Also known as: TKI258
TKI258
sorafenibDRUG

400 mg p.o. b.i.d.

Sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Novartis Investigative Site

Nanjing, Jiangsu, 210002, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710032, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310016, China

Location

Novartis Investigative Site

Beijing, 100039, China

Location

Novartis Investigative Site

Shatin, New Territories, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 232-0024, Japan

Location

Novartis Investigative Site

Sayama, Osaka, 589-8511, Japan

Location

Novartis Investigative Site

Singapore, 308433, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 03722, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06351, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Seoul, 136-705, South Korea

Location

Novartis Investigative Site

Taichung, Taiwan, 40705, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 10048, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, ROC, 112, Taiwan

Location

Novartis Investigative Site

Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 33305, Taiwan

Location

Novartis Investigative Site

Bangkok, 10330, Thailand

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Khon Kaen, 40002, Thailand

Location

Novartis Investigative Site

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-oneSorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2010

First Posted

November 2, 2010

Study Start

July 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 4, 2015

Results First Posted

December 4, 2015

Record last verified: 2015-11

Locations

TW(4)CN(4)JP(3)HK(2)TH(5)SG(1)KR(5)