Dose Finding Safety Study of VAL201 in Cancer Patients (VAL201-001)

The study will enrol patients with locally advanced or metastatic prostate cancer. The MTD/MAD may also be evaluated in patients with other advanced tumour types for whom no standard effective therapy is available and a rationale for use of VAL201 exists.

The average timeframe is 18-26 weeks per subject and the outcome measured is a composite average for each group.

• Inclusion criteria:

  • Specific Inclusion Criteria for Patients with Prostate Cancer
  • Patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. Who have specific clinical parameters.

• Specific Inclusion Criteria for Patients with Other Advanced Solid Tumours

  • Patients with histologically and/or cytologically confirmed advanced solid tumour for whom no standard effective therapy is available and a rationale for use of VAL201 exists.

  • Patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. These patients must also have the following:

    1. Rising PSA on three samples (once non-castrate levels established); each over 2 weeks apart, with the last two values being greater than 2 ng/mL. Higher than and at least 25% over the nadir.
    2. Absent or very mild prostate cancer-related symptoms.
    3. No plans for any therapy for prostate cancer in the next two months.
  • General Inclusion Criteria for all Patients
  • Adult patients defined by age greater than 18 years at time of consent.
  • Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
  • Patient is capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
  • Evaluable disease, either measurable on imaging, or with informative tumour marker(s) and a set of specific biochemical and haematological parameters relating to the specific cancer.
  • Negative human chorionic gonadotropin (hCG) test in women of childbearing potential.
  • Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control. Female patients may be surgically sterile.

  • Laboratory values at Screening:

    • Absolute neutrophil count ≥1.5 x 109/L.
    • Platelets ≥100 x 109/L.
    • Haemoglobin ≥9 g/dL without blood transfusion or colony stimulating factor support.
    • Total bilirubin <1.5 times the upper limit of normal (ULN);
    • AST (SGOT) ≤2.5 times the ULN;
    • ALT (SGPT) ≤2.5 times the ULN; ≤5 x ULN for patients with advanced solid tumours with liver metastases.
    • Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate (GFR) of >50 mL/min based on the Cockcroft-Gault formula.

• Exclusion criteria

  • Specific Exclusion Criteria for Patients with Prostate Cancer Patients has received an anticancer therapy, including investigational agents, within the precious 6 weeks or 4 weeks.
  • Any patients who have undergone prior orchidectomy.
  • Specific Exclusion Criteria for Patients with Other Advanced Solid Tumours Pregnant or lactating female patients.
  • Documented, symptomatic or uncontrolled brain metastases.
  • History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months previous to the indication of home therapy.
  • Known Human Immunodeficiency Virus positivity.
  • Active Hepatitis B or C or other active liver disease (other than malignancy).
  • Any active, clinically significant, viral, bacterial, or systemic fungal infection within previous 4 weeks prior to home therapy.
  • Any medical history that would jeopardize compliance.