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

This study has been terminated.
(The study was stopped because of slow accrual)
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
CureTech Ltd
ClinicalTrials.gov Identifier:
NCT00966251
First received: August 25, 2009
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Primary Hepatocellular Carcinoma
Drug: CT-011
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CureTech Ltd:

Primary Outcome Measures:
  • To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT-011 Drug: CT-011
CT-011

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966251

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
CureTech Ltd
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Yaron Ilan, MD Hadassah Medical Center
  More Information

No publications provided

Responsible Party: CureTech Ltd
ClinicalTrials.gov Identifier: NCT00966251     History of Changes
Other Study ID Numbers: CT-2009-02
Study First Received: August 25, 2009
Last Updated: October 22, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by CureTech Ltd:
Primary Hepatocellular Carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014