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

Primary Purpose

Primary Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
CT-011
Sponsored by
CureTech Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hepatocellular Carcinoma focused on measuring Primary Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT-011

Arm Description

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma

Secondary Outcome Measures

Full Information

First Posted
August 25, 2009
Last Updated
October 22, 2012
Sponsor
CureTech Ltd
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00966251
Brief Title
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Official Title
Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped because of slow accrual
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CureTech Ltd
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hepatocellular Carcinoma
Keywords
Primary Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-011
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CT-011
Intervention Description
CT-011
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaron Ilan, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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