Status:
TERMINATED
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Lead Sponsor:
CureTech Ltd
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Primary Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- Subjects aged 18 years and above, both genders.
- Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
- No fibrolamellar subtype HCC
- Not eligible for any other systemic anti-neoplastic treatment approved for HCC
- Not eligible for Transarterial chemoembolization (TACE ).
- No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.
- Not a candidate for curative surgical resection or liver transplantation
- 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.
- Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
- Child's Pugh classification A
- ECOG performance status 0-1
Exclusion
- Patients progressing to liver failure.
- No core biopsy within the past 7 days
- Patients who are eligible for Transarterial Chemoembolization (TACE)
- Patients on concurrent anti-neoplastic therapy (including interferon)
- Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
- Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
- Presence of metastasis.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00966251
Start Date
October 1 2009
End Date
June 1 2011
Last Update
October 23 2012
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel