Clinical trial NCT02280317: Dose Finding Safety Study of VAL201 in Cancer Patients
Official title: A Phase I/II, Dose Escalation Study To Assess The Safety and Tolerability of VAL201 In Patients With Advanced or Metastatic Prostate Cancer and Other Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stage III Prostate Carcinoma
Stage IV Prostate Carcinoma
Lead sponsor: ValiRx Plc
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose Escalation sequential assignment
Primary purpose: TREATMENT

Brief summary: Dose finding safety study of VAL201 in cancer patients.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Dose-Limiting Toxicity
timeFrame: The average timeframe is 18-26 weeks per subject
Secondary outcomes:
measure: Pharmacokinetics of VAL201. (Cmax)
timeFrame: The average timeframe is 18-26 weeks per subject
measure: Pharmacokinetics of VAL201 (AUC 0-inf)
timeFrame: The average timeframe is 18-26 weeks per subject
Other outcomes:
measure: Number of Patients Who Completed 6 Cycles of Treatment
timeFrame: The average timeframe is 18-26 weeks per subject
measure: Number of Patients Displaying Disease Progression by PCWG2 and/or RECIST Criteria
timeFrame: The average timeframe is 18-26 weeks per subject
Locations:
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