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).

Carcinoma, Hepatocellular Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855218
• Other study ID #: 12918
• Secondary ID: 2008-005056-24
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2009
• Last updated: July 15, 2014
• Start date: March 2009
• Est. completion date: February 2013

Study information

• Verified date: July 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Institutional Review BoardCanada: Health CanadaChina: Ministry of HealthFrance: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthSpain: Ministry of HealthTaiwan: Institutional Review BoardUnited States: Food and Drug AdministrationSingapore: Health Sciences AuthorityKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Safety issues will be reported in Adverse Event section. In addition to the secondary outcome measures, Biomarkers and Patient Report Outcome will also be analyzed as other variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: February 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  France,  Germany,  Italy,  Korea, Republic of,  Singapore,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From randomization of the first participant until 28 months later (cut-off date)	No
Secondary	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.	From randomization of the first participant until 28 months later (cut-off date)	No
Secondary	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.	From randomization of the first participant until 28 months later (cut-off date)	No
Secondary	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.	From randomization of the first participant until 28 months later (cut-off date)	No
Secondary	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.	From randomization of the first participant until 28 months later (cut-off date)	No
Secondary	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.	From randomization of the first participant until 28 months later (cut-off date)	No

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