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Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00966251
Recruitment Status : Terminated (The study was stopped because of slow accrual)
First Posted : August 26, 2009
Last Update Posted : October 23, 2012
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
CureTech Ltd

Tracking Information
First Submitted Date  ICMJE August 25, 2009
First Posted Date  ICMJE August 26, 2009
Last Update Posted Date October 23, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2009)
To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Official Title  ICMJE Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Brief Summary The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Hepatocellular Carcinoma
Intervention  ICMJE Drug: CT-011
CT-011
Study Arms  ICMJE Experimental: CT-011
Intervention: Drug: CT-011
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 22, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2009)
10
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects aged 18 years and above, both genders.
  2. Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
  3. No fibrolamellar subtype HCC
  4. Not eligible for any other systemic anti-neoplastic treatment approved for HCC
  5. Not eligible for Transarterial chemoembolization (TACE ).
  6. No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.
  7. Not a candidate for curative surgical resection or liver transplantation
  8. Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.
  9. Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
  10. Child's Pugh classification A
  11. ECOG performance status 0-1

Exclusion Criteria:

  1. Patients progressing to liver failure.
  2. No core biopsy within the past 7 days
  3. Patients who are eligible for Transarterial Chemoembolization (TACE)
  4. Patients on concurrent anti-neoplastic therapy (including interferon)
  5. Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
  6. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
  7. Presence of metastasis.
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 Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00966251
Other Study ID Numbers  ICMJE CT-2009-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CureTech Ltd
Study Sponsor  ICMJE CureTech Ltd
Collaborators  ICMJE Teva Pharmaceutical Industries
Investigators  ICMJE
Principal Investigator: Yaron Ilan, MD Hadassah Medical Center
PRS Account CureTech Ltd
Verification Date October 2012

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