Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
NCT ID: NCT00966251
Last Updated: 2012-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
2 participants
INTERVENTIONAL
2009-10-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CT-011
CT-011
CT-011
Interventions
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CT-011
CT-011
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
CureTech Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yaron Ilan, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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CT-2009-02
Identifier Type: -
Identifier Source: org_study_id