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Trial record 1 of 1 for:    NCT01008358
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Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT01008358
Recruitment Status : Completed
First Posted : November 4, 2009
Last Update Posted : June 8, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Tracking Information
First Submitted Date  ICMJE November 3, 2009
First Posted Date  ICMJE November 4, 2009
Last Update Posted Date June 8, 2012
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
Changes in Hepatitis C Virus (HCV) viral load
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Official Title  ICMJE Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Brief Summary CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Hepatitis C Virus Chronic Infection
Intervention  ICMJE Biological: CP 675,206
Study Arms  ICMJE Not Provided
Publications * Sangro B, Gomez-Martin C, de la Mata M, Iñarrairaegui M, Garralda E, Barrera P, Riezu-Boj JI, Larrea E, Alfaro C, Sarobe P, Lasarte JJ, Pérez-Gracia JL, Melero I, Prieto J. A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C. J Hepatol. 2013 Jul;59(1):81-8. doi: 10.1016/j.jhep.2013.02.022. Epub 2013 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unequivocal diagnosis of HCC
  • unresectable disease not amenable to locoregional treatment.
  • a 4-week washout period after sorafenib or any other systemic agent
  • a 2-month washout period after internal or external radiation
  • HCV chronic infection
  • Child-Pugh stage A or B
  • Measurable disease according to RECIST criteria
  • ECOG < 2
  • expected survival > 3 months
  • Adequate liver, renal and blood functions
  • ability to sign informed consent

Exclusion Criteria:

  • previous treatment with an anti-CTL-4 agent
  • serious infections or disease compromising general health status
  • autoimmune disease that requires therapy
  • treatment with immunosuppressors
  • treatment with investigational agents
  • other neoplasms except skin and bladder superficial tumors
  • pregnancy or lactation
  • SNC metastasis
  • HIV infection
  • relevant heart disease (NYHA class III or IV)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008358
Other Study ID Numbers  ICMJE CT-2007-01
EudraCT number 2008-001177-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinica Universidad de Navarra, Universidad de Navarra
Study Sponsor  ICMJE Clinica Universidad de Navarra, Universidad de Navarra
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Jesús Prieto-Valtuena, MD, PhD Clinica Universidad de Navarra
PRS Account Clinica Universidad de Navarra, Universidad de Navarra
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP