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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00855218




Registration number
NCT00855218
Ethics application status
Date submitted
3/03/2009
Date registered
4/03/2009
Date last updated
18/08/2017

Titles & IDs
Public title
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
Scientific title
A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).
Secondary ID [1] 0 0
2008-005056-24
Secondary ID [2] 0 0
12918
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Hepatocellular 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sorafenib (Nexavar, BAY43-9006)
Treatment: Drugs - Placebo

Experimental: Sorafenib (Nexavar, BAY43-9006) + TACE - Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)

Placebo Comparator: Placebo + TACE - Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)


Treatment: Drugs: Sorafenib (Nexavar, BAY43-9006)
800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. [twice daily], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead

Treatment: Drugs: Placebo
4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Progression (TTP) - Independent Radiological Review (Primary Analysis) - TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.
Timepoint [1] 0 0
From randomization of the first participant until 28 months later (cut-off date)
Secondary outcome [1] 0 0
Overall Survival (OS) - Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact.
Timepoint [1] 0 0
From randomization of the first participant until 28 months later (cut-off date)
Secondary outcome [2] 0 0
Time to Untreatable Progression (TTUP) - Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.
Timepoint [2] 0 0
From randomization of the first participant until 28 months later (cut-off date)
Secondary outcome [3] 0 0
Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES) - Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.
Timepoint [3] 0 0
From randomization of the first participant until 28 months later (cut-off date)
Secondary outcome [4] 0 0
Tumor Response - Independent Radiological Review - Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Timepoint [4] 0 0
From randomization of the first participant until 28 months later (cut-off date)
Secondary outcome [5] 0 0
Tumor Response - Investigator Assessment - Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Timepoint [5] 0 0
From randomization of the first participant until 28 months later (cut-off date)

Eligibility
Key inclusion criteria
- Unresectable, multinodular asymptomatic tumor without vascular invasion or
extrahepatic spread

- Confirmed Diagnosis of HCC:

- Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver
Diseases (AASLD) criteria

- HCC can be defined in cirrhotic subjects by one imaging technique (Computed tomography
[CT] scan, Magnetic resonance imaging [MRI], or second generation contrast ultrasound)
showing a nodule larger than 2 cm with contrast uptake in the arterial phase and
washout in venous or late phases or two imaging techniques showing this radiological
behavior for nodules of 1-2 cm in diameter.

- Cytohistological confirmation is required for subjects who do not fulfill these
eligibility criteria.

- Non-cirrhotic subjects:

For subjects without cirrhosis, histological or cytological confirmation is mandatory

- Documentation of original biopsy for diagnosis is acceptable

- Child Pugh class A without ascites

- Adequate bone marrow, liver and renal function as assessed by central lab by means of
the following laboratory requirements from samples within 7 days prior to
randomization:
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients on a liver transplantation list or with advanced liver disease as defined
below:

- Child Pugh B and C

- Active gastrointestinal bleeding

- Encephalopathy

- Ascites

- Lesions having previously been treated with local therapy such as resection of HCC,
radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation
can not be selected as the target lesions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- St Leonards
Recruitment hospital [3] 0 0
- Greenslopes
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Austria
State/province [12] 0 0
Innsbruck
Country [13] 0 0
Austria
State/province [13] 0 0
Wien
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles - Brussel
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Belgium
State/province [16] 0 0
Liege
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Nova Scotia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
China
State/province [20] 0 0
Guangdong
Country [21] 0 0
China
State/province [21] 0 0
Shannxi
Country [22] 0 0
China
State/province [22] 0 0
Beijing
Country [23] 0 0
China
State/province [23] 0 0
Shanghai
Country [24] 0 0
France
State/province [24] 0 0
Creteil
Country [25] 0 0
France
State/province [25] 0 0
Lille
Country [26] 0 0
France
State/province [26] 0 0
Lyon Cedex
Country [27] 0 0
France
State/province [27] 0 0
Lyon
Country [28] 0 0
France
State/province [28] 0 0
Marseille
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Vandoeuvre-les-nancy
Country [31] 0 0
France
State/province [31] 0 0
Villejuif
Country [32] 0 0
Germany
State/province [32] 0 0
Baden-Württemberg
Country [33] 0 0
Germany
State/province [33] 0 0
Bayern
Country [34] 0 0
Germany
State/province [34] 0 0
Hessen
Country [35] 0 0
Germany
State/province [35] 0 0
Niedersachsen
Country [36] 0 0
Germany
State/province [36] 0 0
Nordrhein-Westfalen
Country [37] 0 0
Germany
State/province [37] 0 0
Rheinland-Pfalz
Country [38] 0 0
Germany
State/province [38] 0 0
Saarland
Country [39] 0 0
Germany
State/province [39] 0 0
Thüringen
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Italy
State/province [42] 0 0
Campania
Country [43] 0 0
Italy
State/province [43] 0 0
Emilia-Romagna
Country [44] 0 0
Italy
State/province [44] 0 0
Lazio
Country [45] 0 0
Italy
State/province [45] 0 0
Lombardia
Country [46] 0 0
Italy
State/province [46] 0 0
Piemonte
Country [47] 0 0
Italy
State/province [47] 0 0
Puglia
Country [48] 0 0
Italy
State/province [48] 0 0
Sicilia
Country [49] 0 0
Italy
State/province [49] 0 0
Toscana
Country [50] 0 0
Italy
State/province [50] 0 0
Veneto
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Daegu
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Gyeonggi-do
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Singapore
State/province [54] 0 0
Singapore
Country [55] 0 0
Spain
State/province [55] 0 0
A Coruña
Country [56] 0 0
Spain
State/province [56] 0 0
Asturias
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Bilbao
Country [59] 0 0
Spain
State/province [59] 0 0
Catalunya
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Santa Cruz de Tenerife
Country [62] 0 0
Spain
State/province [62] 0 0
Alicante
Country [63] 0 0
Spain
State/province [63] 0 0
Córdoba
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
Spain
State/province [65] 0 0
Valencia
Country [66] 0 0
Taiwan
State/province [66] 0 0
Changhua
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will look at whether our drug (sorafenib) in combination with chemotherapy
delivered directly into your tumor using beads (DC Bead) will slow the progression of the
disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing
the adverse effects that normally occur with chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT00855218
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications