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

This study has been completed.
Sponsor:
Information provided by:
Pharmexa A/S
ClinicalTrials.gov Identifier:
NCT00444782
First received: March 7, 2007
Last updated: December 17, 2008
Last verified: December 2008
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
Biological: GV1001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Pharmexa A/S:

Primary Outcome Measures:
  • Response rate (Partial and Complete Response) according to modified RECIST. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Progression (TTP) [ Designated as safety issue: No ]
  • Time to Symptomatic Progression (TTSP) [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Designated as safety issue: No ]
  • Immune Response [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444782

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

No publications provided by Pharmexa A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lotte Rosendahl, Pharmexa
ClinicalTrials.gov Identifier: NCT00444782     History of Changes
Other Study ID Numbers: PX115.1.1-201
Study First Received: March 7, 2007
Last Updated: December 17, 2008
Health Authority: Spain: Spanish Drugs and Health Product Agency

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

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

ClinicalTrials.gov processed this record on April 20, 2014