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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444782
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : December 18, 2008
Information provided by:
Pharmexa A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Biological: GV1001 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Heptovax" - A Phase II, Open-Label Trial Evaluating the Safety and Efficacy of GV1001 in Advanced Hepatocellular Carcinoma.
Study Start Date : November 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Primary Outcome Measures :
  1. Response rate (Partial and Complete Response) according to modified RECIST.

Secondary Outcome Measures :
  1. Time to Progression (TTP)
  2. Time to Symptomatic Progression (TTSP)
  3. Progression Free Survival (PFS)
  4. Immune Response

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444782

Michel Beaugrand
Bondy, France, 93143
Tim F. Greten
Hannover, Germany, 30625
Jordi Bruix
Barcelona, Spain, E-08036
Sponsors and Collaborators
Pharmexa A/S
Study Chair: Lotte Rosendahl, Pharmacist (CTM) Pharmexa A/S

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lotte Rosendahl, Pharmexa Identifier: NCT00444782     History of Changes
Other Study ID Numbers: PX115.1.1-201
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008

Keywords provided by Pharmexa A/S:
Advanced Carcinoma, Hepatocellular

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases