A Phase II, Open-Label Trial Evaluating GV1001 in Advanced Hepatocellular Carcinoma.

December 17, 2008 updated by: Pharmexa A/S

"Heptovax" - A Phase II, Open-Label Trial Evaluating the Safety and Efficacy of GV1001 in Advanced Hepatocellular Carcinoma.

The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93143
        • Michel Beaugrand
  • Germany
      • Hannover, Germany, 30625
        • Tim F. Greten
  • Spain
      • Barcelona, Spain, E-08036
        • Jordi Bruix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hepatocellular carcinoma diagnosis fulfilling one of the following criteria (as per the American Association for the Study of Liver Diseases [AASLD] guidelines, see Appendix 5):

    1. Nodule in a cirrhotic or non-cirrhotic liver with a biopsy showing HCC;

    2. Nodule in cirrhotic liver where no biopsy is performed:

      • Nodules between 1-2 cm in a cirrhotic liver with a typical coincidal vascular pattern of HCC (i.e. hypervascular with washout in the portal/venous phase) in two dynamic studies: either CT scan, contrast ultrasound or MRI with contrast.
      • Nodule larger than 2 cm in a cirrhotic liver with a typical vascular pattern of HCC on a dynamic imaging technique.

Please note: HCC in a non-cirrhotic liver can only be diagnosed with a biopsy showing HCC.

  • Measurable disease according to modified RECIST (see Appendix 7).
  • At least one treatment-naïve target lesion (treatment-naïve being defined as not having been treated with local therapy, such as surgery, radiation therapy, hepatic arterial embolisation, chemoembolisation, radio-frequency ablation or cryo-ablation).
  • Barcelona Clinic Liver Cancer (BCLC) stage A, B or C (see Appendix 6) (Stage D is excluded).
  • Child-Pugh stage A (see Appendix 8).
  • Male or female aged 18 years or older.

  • Adequate haematological parameters, as demonstrated by:

    • Haemoglobin greater than or equal to 9.0 g/dL (SI units: 5.6 mmol/L);
    • WBC greater than or equal to 3.0 x 109/L;
    • Platelets greater than or equal to 75 x 109/L.
  • ALT and AST ≤ 5 times the upper limit of normal.
  • Bilirubin < 2 mg/dL.
  • Serum creatinine smaller than or equal to 1.5 mg/dL (SI units: 132 µmol/L).
  • Performance status ECOG 0 or 1.
  • Minimum life expectancy of 3 months at screening.
  • Written informed consent given prior to any study specific procedures.

Exclusion Criteria:

  • HCC amenable to curative treatment or transplantation.
  • History of other malignancies in the last 5 years (10 years in the case of breast cancer), except for adequately treated non-melanoma skin cancers (Basal Cell Carcinoma, Squamous Cell Carcinoma) and carcinoma in situ of the cervix.
  • Known history of or co-existing autoimmune disease.
  • Known Central Nervous System (CNS) metastases.
  • Known history of human immunodeficiency virus (HIV).
  • Any medical condition that, in the opinion of the Investigator, may compromise the compliance of the patient to receive study treatment and follow study procedures.
  • Treatment with any other IMP within 4 weeks prior to cyclophosphamide administration at Day -3.
  • Known sensitivity to any components of cyclophosphamide, GV1001 or GM-CSF.

  • Concomitant treatment with the following within 4 weeks of pre-treatment with cyclophosphamide:

    • Anti-tumour treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors, and gene therapy) and vaccines.
    • Chronic corticosteroids (inhaled and topical steroids are permitted including low dose steroids at non-immunosuppressive doses e.g. 15 mg prednisolone daily for up to 7 days).
    • Herbal medicine either containing hypericum perforacum (e.g., St Johns Wort) or claiming to have anti-tumour effects (e.g., Iscador).
  • Pregnancy or lactation.
  • Women of childbearing potential not using reliable and adequate contraceptive methods, defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
  • Unable for any other reason to comply with the protocol (treatment or assessments).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate (Partial and Complete Response) according to modified RECIST.

Secondary Outcome Measures

Outcome Measure
Time to Progression (TTP)
Time to Symptomatic Progression (TTSP)
Progression Free Survival (PFS)
Immune Response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmexa A/S

Investigators

  • Study Chair: Lotte Rosendahl, Pharmacist (CTM), Pharmexa A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PX115.1.1-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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