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    Summary
    EudraCT Number:2013-004009-25
    Sponsor's Protocol Code Number:VAL201-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-02-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-004009-25
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    A.3.2Name or abbreviated title of the trial where available
    Dose finding safety study of VAL201 in cancer patients
    A.4.1Sponsor's protocol code numberVAL201-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorValiRx plc
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportValiRx
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiamond Pharma Services Limited
    B.5.2Functional name of contact pointDiamond Biopharm
    B.5.3 Address:
    B.5.3.1Street AddressSuite 2, Ground Floor, Field House, Station Approach
    B.5.3.2Town/ cityHarlow, Essex
    B.5.3.3Post codeCM20 2FB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0203 9119410
    B.5.5Fax number01279 418964
    B.5.6E-mailaappleyard@diamondpharmaservices.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVAL201
    D.3.2Product code VAL201
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet proposed
    D.3.9.2Current sponsor codeVAL201
    D.3.9.3Other descriptive nameanti-androgen 10-amino acid peptide
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced or Metastatic Prostate Cancer and other Advanced Solid Tumours
    E.1.1.1Medical condition in easily understood language
    Prostate cancer and other cancers that have solid tumours
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find out the maximum amount of VAL201 that can be safely given to cancer patients, as well as the maximum amount of VAL201 that can be given and tolerated (ie the highest dose that does not start to cause significant adverse effects in patients).
    E.2.2Secondary objectives of the trial
    1) To assess how safe and well tolerated VAL201 is when given to patients with cancer by looking at any side effects that patients experience
    2) To assess the way the body absorbs, distributes, and gets rid of VAL201 by analysing the drug levels in the blood
    3) To assess if VAL201 has any positive effect on the patient's cancer

    There are also exploratory objectives to perform laboratory analysis to assess biomarkers in both blood and tumour tissues. Biomarkers are naturally occuring indicators of disease, ie something that can used to evaluate a disease state or to monitor change.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (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.
    E.4Principal exclusion criteria
    (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.
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the maximum tolerated dose (MTD) and maximum administered dose (MAD) for VAL201.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dose limiting toxicity evaluation in cohorts of 3-6 patients. Assessment to be made at the end of one treatment cycle (21 days).
    E.5.2Secondary end point(s)
    Ongoing evaluation of adverse events during patient treatment and follow up

    Assessment of pharmacokinetic variables (including, but not limited to, Max Concentration, Min Concentration, area under the curve)

    Tumour response to treatment with VAL201, assessment made against by PCWG2 for prostate cancer with RECIAT used for other solid tumours.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability - assessed over whole study.

    PK
    Cohort 1-4
    PK profile taken over cycle 1 as follows:
    Day 1: pre-dose (0h) then 5, 10, 15, 30 min, 1, 2, 3, 4, 6, 8, 10 and 24 h post-administration.
    Day 8: pre-dose (0h) then 5, 10, 15, 30 min, 1, 2, 3, 4, 6, 8, 10 and 24 h post-administration.
    Day 15:immediately prior to administration
    Then PK sample taken on Day 1 of all further cycels, immediately prior to administration

    Cohort 5-6
    - Cycle 1,3,4 & 6 - Day 1: pre-dose (0h) then 5, 10, 15, 30 min, 1, 2, 3, 5, 8 and 24h post-administration
    - Cycle 1 & 4 - Day 15: pre dose (0h) and 1h post dose
    - Cycle 2 & 5 - Day 1: pre-dose (0h) then 1h post-dose

    Tumour response to VAL201 is to be evaluated at the end of every 3rd cycle.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    This is Phase I/II as it has secondary therapeutic endpoints evaluating disease response in patients
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state81
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 81
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Up to 6 treatment cycles is planned within the design of this study. Patients who have responded positively to study treatment and whose disease has not progressed will be eligible to continue to receive additional cycles of VAL201 where this is recommended by their study physician. Such patients may continue to be treated and followed up as part of this protocol, or be transferred to an extended treatment protocol.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-01-27
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