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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444782
• Other study ID #: PX115.1.1-201
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: December 17, 2008
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: December 2008
• Source: Pharmexa A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drugs and Health Product Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Biological:
• GV1001

Locations

Country	Name	City	State
France	Michel Beaugrand	Bondy
Germany	Tim F. Greten	Hannover
Spain	Jordi Bruix	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Pharmexa A/S

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (Partial and Complete Response) according to modified RECIST.			No
Secondary	Time to Progression (TTP)			No
Secondary	Time to Symptomatic Progression (TTSP)			No
Secondary	Progression Free Survival (PFS)			No
Secondary	Immune Response			No