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

ValiRx

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stage IV Prostate Carcinoma; Stage III Prostate Carcinoma

Treatments: Drug: VAL201

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280317

2013-004009-25 (EudraCT Number)

VAL201-001

Details and patient eligibility

About

Dose finding safety study of VAL201 in cancer patients.

Full description

A Phase I/II, dose escalation study to assess the safety and tolerability of VAL201 in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 5 patient groups

Cohort 1: 0.5 mg/kg

Experimental group

Description:

VAL201-001 Sub-cutaneous injection. 0.5 mg/kg

Treatment:

Drug: VAL201

Cohort 2: 1 mg/kg

Experimental group

Description:

VAL201-001 Sub-cutaneous injection. 1.0 mg/kg

Treatment:

Drug: VAL201

Cohort 3: 2 mg/kg

Experimental group

Description:

VAL201-001 Sub-cutaneous injection. 2.0 mg/kg

Treatment:

Drug: VAL201

Cohort 4: 4 mg/kg

Experimental group

Description:

VAL201-001 Sub-cutaneous injection. 4.0 mg/kg

Treatment:

Drug: VAL201

Cohort 5: up to 8 mg/kg

Experimental group

Description:

VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.

Treatment:

Drug: VAL201