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    Summary
    EudraCT Number:2011-003311-27
    Sponsor's Protocol Code Number:CLIN1102KCM201
    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:2012-09-07
    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 number2011-003311-27
    A.3Full title of the trial
    Vascular Targeted Photodynamic therapy with WST11 for T1a Renal Tumours. PHASE IIa histological follow up trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Light activated drug treatment for small kidney tumours
    A.3.2Name or abbreviated title of the trial where available
    Vascular Targeted Photodynamic therapy with WST11 for T1a Renal Tumour
    A.4.1Sponsor's protocol code numberCLIN1102KCM201
    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 SponsorUniversity of Oxford
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSTEBA BIOTECH
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNuffield Department of Surgical Sciences, University of Oxford
    B.5.2Functional name of contact pointTom Leslie
    B.5.3 Address:
    B.5.3.1Street AddressHIFU Unit, Churchill Hospital
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX44 9LS
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailtom.leslie@nds.ox.ac.uk
    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 nameWST11
    D.3.2Product code WST11
    D.3.4Pharmaceutical form Powder for solution for injection or infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPadeliporfin
    D.3.9.1CAS number 886845-72-3
    D.3.9.2Current sponsor codeWST11
    D.3.9.3Other descriptive namePalladium Bacteriopheophorbide Monolysotaurine
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    T1a renal cancer
    E.1.1.1Medical condition in easily understood language
    Tumours in the kidney less than 4cm in diameter
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10038391
    E.1.2Term Renal cancer stage I
    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 evaluate efficacy of VTP treatment as assessed by histology in T1a Renal Tumours
    E.2.2Secondary objectives of the trial
    To evaluate technical success of VTP treatment as assessed by radiology follow-up in T1a Renal Tumours (radiological evidence of tumour destruction at day 12 following VTP treatment) To evaluate safety and toxicity of VTP treatment for T1a Renal Tumours To improve treatments parameters and patient selection for future treatments for T1a Renal Tumours
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant is willing and able to give informed consent for participation in the study. • Male or post-menopausal female, aged 18 years or above. • Lesions suspicious for renal cell carcinoma on triple phase CT that are < 4cm in maximum diameter and suitable for surgical resection • Participant must be in sufficiently good health to be suitable for general anaesthesia for both VTP treatment and subsequent surgical resection of tumour • Subjects must have ≥ 1 evaluable tumours which can be visualised on diagnostic ultrasound. If more than one tumour exists, an index tumour will be nominated and treated (uncommon) • Previous chemotherapy and / or biological therapy for cancer are permitted, but the subject should have recovered fully from the effects of these and any prior surgery (minimum of 28 days). • Patients should not have received radiotherapy to the target area within the preceding 12 months. • Subject has clinically acceptable haematological, electrolyte and hepatic function as demonstrated by serum laboratory values within 14 days prior of VTP treatment:  Absolute neutrophil count (ANC) ≥ 1500mm-3  Platelet count ≥ 100,000mm-3  Haemoglobin ≥ 10gdl-1  Prothrombin time (PT) ≤ 1.5 * Upper Limit of Normal (ULN)  Activated partial thomboplastin time (APPT) ≤ 1.5 * ULN  Total bilirubin < 2.5 * ULN  Aspartate aminotransferase (AST) < 3 * ULN  Alkaline phosphatase (ALP) < 2 * ULN; unless arising from bone • Participant has a clinically acceptable ECG • Able (in the Investigators opinion) and willing to comply with all study requirements. • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
    E.4Principal exclusion criteria
    • Non menopausal women • Significant hepatic impairment. • Significant renal impairment as to mean surgical resection is unsuitable • Clinical or radiological evidence of metastatic disease • Subjects with tumours lying adjacent to vital structures such that VTP treatment would risk damage to these structures • Subjects currently taking immunosuppressive medication • Patients whose medical conditions need the following medication which have potential photosensitising effects (tetracyclines, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, amiodarone and griseofulvin) if these treatments cannot be stopped or replaced by other treatments without photosensitizing properties • Patients who have an absolute need for anticoagulant drugs or antiplatelet drugs (e.g., warfarin, aspirin) which cannot be withdrawn during the 10 days prior to the VTP procedure. • Scheduled elective surgery or other procedures requiring general anaesthesia during the study. • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. • Participants involved in the treatment phase of a clinical trial (observational or follow-up studies will be allowed) • An American Society of Anaesthesiologists (ASA) score of ≥ 3 • A World Health Organisation (WHO) performance status of ≥2
    E.5 End points
    E.5.1Primary end point(s)
    Volume of tumour necrosis on final histology expressed as a percentage of pre-treatment tumour volume
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following the partial nephrectomy, which will be 2-4 weeks following the VTP treatment
    E.5.2Secondary end point(s)
    Complete destruction of targeted tumour on day 12 MRI imaging AEs / toxicity following VTP treatment Oncological outcome (assessed radiologically) following VTP & surgery up to 1 year post treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 12 MRI Up to 1 year following surgery
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    The end of trial is 1 year following the partial nephrectomy of the last participant.
    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 months6
    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 months6
    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 No
    F.1.1Number of subjects for this age range: 0
    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: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    Currently there are no arrangements for the continued provision of VTP with WST11 treatment for kidney cancer following the conclusion of the trial. We hope that the results of this trial will lead to the creation of larger scale trials comparing VTP with surgery and a watchful waiting policy. VTP treatment will not be available under on the NHS until such time as these larger trials have been completed.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation n/a
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-09-09
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