Status:
COMPLETED
Dose Finding Safety Study of VAL201 in Cancer Patients
Lead Sponsor:
ValiRx Plc
Conditions:
Stage III Prostate Carcinoma
Stage IV Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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
Inclusion
- 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:
- 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.
- Absent or very mild prostate cancer-related symptoms.
- 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informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.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.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02280317
Start Date
October 1 2014
End Date
January 27 2020
Last Update
November 8 2021
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