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

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ClinicalTrials.gov Identifier: NCT02280317
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2014
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
ValiRx Plc

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

Condition or disease Intervention/treatment Phase
Stage III Prostate Carcinoma Stage IV Prostate Carcinoma Drug: VAL201 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VAL201: Laboratory & Clinical Assessment
VAL201-001 Sub-cutaneous injection.
Drug: VAL201
VAL201-001 Sub-cutaneous injection.
Other Name: VAL201-001




Primary Outcome Measures :
  1. To estimate the MTD/MAD of VAL201. [ Time Frame: The average timeframe is 18-26 weeks per subject ]
    Assessment of the MTD/MAD of VAL201.


Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of VAL201. (Cmax) [ Time Frame: The average timeframe is 18-26 weeks per subject ]
    Assessment of pharmacokinetic variables. (including, but not limited to, Cmax, Cmin, AUC).


Other Outcome Measures:
  1. To assess anti-tumour activity of VAL201 (PCWG2 and/or RECIST) [ Time Frame: The average timeframe is 18-26 weeks per subject ]
    Response assessment by PCWG2 and/or RECIST. other relevant response assessments e.g. RECIST 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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Responsible Party: ValiRx Plc
ClinicalTrials.gov Identifier: NCT02280317     History of Changes
Other Study ID Numbers: VAL201-001
2013-004009-25 ( EudraCT Number )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases