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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. Identifier: NCT00966251
Recruitment Status : Terminated (The study was stopped because of slow accrual)
First Posted : August 26, 2009
Last Update Posted : October 23, 2012
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
CureTech Ltd

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.

Condition or disease Intervention/treatment Phase
Primary Hepatocellular Carcinoma Drug: CT-011 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Study Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: CT-011 Drug: CT-011

Primary Outcome Measures :
  1. To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00966251

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Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
CureTech Ltd
Teva Pharmaceutical Industries
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Principal Investigator: Yaron Ilan, MD Hadassah Medical Center
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Responsible Party: CureTech Ltd Identifier: NCT00966251    
Other Study ID Numbers: CT-2009-02
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012
Keywords provided by CureTech Ltd:
Primary Hepatocellular Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents