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

NCT00966251 | Terminated Phase 1

• 1 other identifier: CT-2009-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hepatocellular Carcinoma

Keywords

Primary Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (1)

CT-011

EXPERIMENTAL

Drug: CT-011

Interventions

CT-011 DRUG

CT-011

CT-011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CureTech Ltd: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

pidilizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yaron Ilan, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2009
• First Posted: August 26, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 23, 2012

Record last verified: 2012-10

Locations

IL (1)