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

Primary Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00966251
• Other study ID #: CT-2009-02
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 25, 2009
• Last updated: October 22, 2012
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2012
• Source: CureTech Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Primary Hepatocellular Carcinoma

Intervention

Drug:
• CT-011
CT-011

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
CureTech Ltd	Teva Pharmaceutical Industries

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma		12 months	Yes