A Clinical Study to investigate the Safety and Tolerability of VAL201 (new trial drug) in Patients with Locally Advanced or Metastatic (cancer cells which spreads from one part of the body to another) Prostate Cancer and Other Advanced Solid Tumours.
- Conditions
- ocally Advanced or Metastatic Prostate Cancer and other Advanced Solid TumoursMedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004009-25-GB
- Lead Sponsor
- ValiRx plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 81
(i) Specific Inclusion Criteria for Patients with Prostate Cancer
1. Patients with incurable, locally advanced or metastatic prostate cancer who have relapsed following radiotherapy treatment, are in ‘watchful waiting’ or where a policy of intermittent hormone therapy has been decided. These patients must also have the following:
a. rising PSA on three samples; each over 2 weeks apart, with the values being greater than 2 ng/mL higher than and at least 25% over the nadir.
b. absent or very mild prostate cancer-related symptoms
c. no plans for any therapy for prostate cancer in the next two months.
2. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of = 1
3. Age =18 years at time of consent.
(ii) Specific Inclusion Criteria for Patients with Other Advanced Solid Tumours
4. 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 e.g. fibrosarcoma, ovarian cancer.
5. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of = 2
6. Age = 16 years at time of consent.
(iii) General Inclusion Criteria for all Patients
7. Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by the PCWG2, or other relevant response assessment criteria for tumour type e.g. RECIST 1.1.
8. Recovery to baseline or CTCAE = grade 1, as determined by CTCAE v4.03 criteria, of reversible toxicities related to prior treatment, with the exception of alopecia, lymphopenia, other non-clinically significant adverse events, including those considered related to androgen deprivation therapy.
8. Laboratory values at Screening:
• Absolute neutrophil count =1.5 x 10x9/L;
• Platelets =100 x 10x9/L;
• Haemoglobin =90 g/L without blood transfusion or colony stimulating factor support;
• Total bilirubin <1.5 times the upper limit of normal,(excluding patients with Gilberts Disease);;
• AST (SGOT) =2.5 times the upper limit of normal;
• ALT (SGPT) =2.5 times the upper limit of normal; =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
9. Negative human chorionic gonadotropin (hCG) test in women of childbearing potential (defined as women = 50 years of age or history of amenorrhea for = 12 months prior to study entry). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, during the entire duration of the study and for 1 month after final administration of VAL201. Note that female patients may be surgically sterile (with appropriate documentation in the patient’s medical records).
10. 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.
11. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>
(i) Specific Exclusion Criteria for Patients with Prostate Cancer
Patients has received:
1. an anti-cancer therapy, including investigational agents, within 6 weeks of Cycle 1, Day 1;
2. Patients who have undergone prior orchidectomy.
(ii) Specific Exclusion Criteria for Patients with Other Advanced Solid Tumours
3. Patients has received:
a) any chemotherapy regimens (including investigational agents) with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of Cycle 1, Day 1, or received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of Cycle 1, Day 1.
b) radiotherapy, immunotherapy or biological agents (includes investigational agents) within 4 weeks of Cycle 1, Day 1. Localised palliative radiotherapy is permitted for symptom control.
4. Pregnant or lactating female patients.
(iii) General Exclusion Criteria for all Patients
5. Documented, symptomatic or uncontrolled brain metastases.
6. History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months of Cycle 1, Day 1.
7. Known human immunodeficiency virus positivity.
8. Active hepatitis B or C or other active liver disease (other than malignancy).
9. Any active, clinically significant, viral, bacterial, or systemic fungal infection within 4 weeks prior to Cycle 1, Day 1.
10. Any medical history that in the Investigator's opinion would jeopardize compliance with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method