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Sorafenib or Placebo in Combination With TACE for Intermediate Stage Hepatocellular Carcinoma (SPACE)
This study is currently recruiting participants.
Verified by Bayer, March 2009
First Received: March 3, 2009   Last Updated: March 31, 2009   History of Changes
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00855218
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo
Phase II

Drug Information available for: Sorafenib Sorafenib tosylate Chlorotrianisene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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).

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to progression (TTP) [ Time Frame: Time from randomization to radiological disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Time from randomization to death due to any cause. OS of subjects alive at the time of analysis will be censored at their last data of follow-up. ] [ Designated as safety issue: No ]
  • Time to untreatable progression (TTUP) [ Time Frame: Time from randomization to untreatable progression ] [ Designated as safety issue: No ]
  • Time to vascular invasion/extrahepatic spread [ Time Frame: Time from randomization to the radiological evidence of vascular invasion/extrahepatic spread confirmed by CT/MRI scan. ] [ Designated as safety issue: No ]
  • Patient reported outcome (PRO) [ Time Frame: Measured by FACT-Hep and EQ-5D - The total scores of both scales will be calculated, the scores of each domain and each question at each time point and their difference from baseline will be summarized for each treatment group. ] [ Designated as safety issue: No ]
  • Biomarker analysis [ Time Frame: If a sufficient number of optional biomarker samples are obtained, exploratory correlative analysis will be performed. ] [ Designated as safety issue: No ]
  • Descriptive summary tables will be presented on all safety parameters by treatment group [ Time Frame: Time of consent to 30 days post end of study for SAEs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: March 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: Nexavar (Sorafenib, BAY43-9006)
800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d., 2 tablets)TACE using DC Bead.
Arm 2: Placebo Comparator Drug: Placebo
4 tablets of placebo will be taken daily (2 tablets b.i.d.)

  Eligibility

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

Inclusion Criteria:

  • Unresectable, multinodular asymptomatic tumor (no vascular invasion or extrahepatic spread)
  • Confirmed Diagnosis of HCC
  • Child Pugh class A
  • ECOG Performance Status of 0
  • At least one uni-dimensional lesion measurable according to the RECIST criteria by CT-scan or MRI
  • Male or female subjects >/=18 years of age
  • Ability to swallow oral medications
  • Life expectancy of at least 12 weeks
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment (assessed centrally)
  • Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
  • Adequate bone marrow, liver and renal function as assessed by central lab

Exclusion Criteria:

  • Diffuse HCC or presence of vascular invasion (including segmental portal obstruction), extrahepatic spread
  • Advanced liver disease: Child Pugh B and C, Active gastrointestinal bleeding, Encephalopathy or clinically relevant ascites
  • Any contraindications for hepatic embolization procedures
  • Target lesion having previously been treated with local therapy
  • Local therapies ongoing or completed < 4 weeks prior to the baseline scan
  • Any >/= CTC AE grade 2 acute toxic effects of any prior local treatment
  • History of cardiac disease
  • Known history of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTCAE Version 3.0), except for HBV and HCV infection
  • Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
  • Thrombotic or embolic events within the 6 months prior to the first dose of study drug
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC,
  • Pregnant or breast-feeding subjects
  • Investigational drug or device therapy outside of this trial during or within 4 weeks of study entry (signing informed consent)
  • Prior transarterial embolization (with or without chemotherapy)
  • Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors or farnesyl transferase inhibitors
  • Prior use of anthracyclines (e.g. doxorubicin)
  • Major surgery within 4 weeks prior to start of study drug
  • Radiotherapy for HCC during study or before start of study drug
  • Use of biologic response modifiers, such as G-CSF, within 3 weeks prior to start of study drug.
  • Autologous bone marrow transplant or stem cell rescue within 1 year prior to start of study drug
  • History of organ allograft
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855218

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 86 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers: 12918, EudraCT: 2008-005056-24
Study First Received: March 3, 2009
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00855218     History of Changes
Health Authority: Austria: Ethikkommission;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Belgium: Institutional Review Board;   Canada: Health Canada;   China: Ministry of Health;   France: Ministry of Health;   Germany: Federal Institute for Drugs and Medical Devices;   Italy: Ministry of Health;   Spain: Ministry of Health;   Taiwan: Institutional Review Board;   United States: Food and Drug Administration;   Singapore: Health Sciences Authority;   Korea: Food and Drug Administration;   United States: Food and Drug Administration

Keywords provided by Bayer:
Sorafenib
TACE
DC bead
Combination

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Protein Kinase Inhibitors
Doxorubicin
Carcinoma
Liver Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on May 06, 2009