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    Summary
    EudraCT Number:2012-002592-34
    Sponsor's Protocol Code Number:ICR-CTSU/2012/10036
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-04
    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 number2012-002592-34
    A.3Full title of the trial
    A Phase II Trial of Vinflunine chemotherapy in locally advanced and metastatic carcinoma of the penis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Trial of Vinflunine chemotherapy in locally-advanced and metastatic carcinoma of the Penis (VinCaP)
    A.3.2Name or abbreviated title of the trial where available
    VinCaP
    A.4.1Sponsor's protocol code numberICR-CTSU/2012/10036
    A.5.4Other Identifiers
    Name:Sponsor Identification NumberNumber:CCR3858
    Name:ICRCTSU protocol numberNumber:ICR-CTSU/2012/10036
    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 SponsorThe Institute of Cancer Research
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportPierre Fabre
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Institute of Cancer Research
    B.5.2Functional name of contact pointStephanie Burnett
    B.5.3 Address:
    B.5.3.1Street AddressDivision of Clinical Studies, Sir Richard Doll Building,
    B.5.3.2Town/ citySutton, Surrey
    B.5.3.3Post codeSM2 5NG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02087224261
    B.5.5Fax number02087707876
    B.5.6E-mailvincap-icrctsu@icr.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 Yes
    D.2.1.1.1Trade name Javlor
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Médicament
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVinflunine
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNVinflunine
    D.3.9.1CAS number 162652-95-1
    D.3.9.2Current sponsor codeCCR 3858
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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
    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
    Locally advanced and metastatic carcinoma of the penis
    E.1.1.1Medical condition in easily understood language
    Locally advanced and metastatic carcinoma of the penis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10034299
    E.1.2Term Penile 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research objective of the VinCaP study is to determine the clinical benefit and toxicity of Vinflunine chemotherapy in inoperable cancer of the penis and thus determine whether this drug warrants further research in this indication.
    E.2.2Secondary objectives of the trial
    The secondary research questions for the VinCap study are: • To assess the objective response rate (complete response and partial response); • To evaluate safety and tolerability; • To assess progression-free and overall survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male, ≥18 years 2. Measurable disease as determined by RECIST (version 1.1) criteria 3. Histologically-proven squamous cell carcinoma of the penis 4. Stage: M1, or; M0, any T, N3 (i.e. involvement of deep inguinal or pelvic lymph nodes) or; M0, any T, N2 (i.e. involvement of multiple or bilateral superficial lymph nodes) or; M0, T4 (tumour invades other adjacent structures) any N Notes: a) Patients with M0 disease may be considered if, in the opinion of the specialist MDT, they are deemed unlikely to benefit from surgery with curative intent and unlikely to tolerate combination chemotherapy due to comorbidities and/or disease burden. b)Patients who have received prior radiotherapy to non-target lesions may be included. 5. Pre-treatment blood counts, haematology and biochemistry values within the following acceptable limits: ANC ≥ 1,500/mm3, Platelets ≥100,000/mm3, GFR ≥ 60ml/min. GFR to be assessed according to local practice (recommended technique of eGFR using the MDRD formula). 6. Performance Status ECOG 0, 1 or 2 7. Written, informed consent
    E.4Principal exclusion criteria
    1. Pure verrucous carcinoma of the penis 2. Squamous carcinoma of the urethra 3. Patients who do not have measurable disease as determined by RECIST (version 1.1) 4. T1 N1 M0 disease 5. T2 N1 M0 disease 6. M0, T3, N1 (tumour invades urethra or prostate and single inguinal node involved) 7. Unfit for vinflunine chemotherapy(as assessed by the multidisciplinary team) 8. Liver function: Bilirubin ≥3xULN in the absence of liver metastases and with either transaminases > ULN or GGT > 5xULN 9. Previous chemotherapy or chemoradiotherapy 10. Contraindication to chemotherapy 11. No other malignancy (other than Squamous Cell Carcinoma or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 5 years. All patients with a previous cancer diagnosis must be discussed with the Chief Investigator prior to entry into the trial. 12. Patients who have received radiotherapy to target lesions and have no other lesions that can act as target lesions instead: e.g. Patients with recurrent pelvic lymph nodes that are deemed irresectable and who have had prior radiotherapy to those lymph nodes: i. are INELIGIBLE if the involved lymph nodes are the only site of disease. ii. are ELIGIBLE if they have other measurable sites of disease e.g. pulmonary metastases. If uncertain, please discuss with the Chief Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Primary: The primary endpoint is clinical benefit (objective response + stable disease rate) measured after four cycles of vinflunine chemotherapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical Benefit: The clinical benefit rate is defined as the proportion of patients having achieved partial remission, complete remission or stable disease according to RECIST criteria (v1.1) on imaging and/ or bi-dimensional clinical measurements (of skin disease) performed after 4 cycles (approximately 11-12 weeks from Day 1 of first cycle).All scans will be reviewed centrally. The clinical benefit rate will be presented along its 95% CI.
    E.5.2Secondary end point(s)
    • Objective response rate (complete response and partial response) • Toxicity; • Progression-free survival; • Overall survival; • Treatment compliance.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints • Objective response rate defined as the proportion of patients having achieved partial or complete remission. • Toxicity will be evaluated, using the CTCAE v4 scoring, after each cycle, at the end of treatment and follow up visits. • Progression-free survival defined as time from registration until the first of clinically or radiologically documented disease progression, or death from any cause death. • Overall survival will be defined as the time from registration until death from any cause. • Treatment Compliance will be defined as proportion of planned doses delivered.
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned10
    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 Yes
    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 study end date is deemed to be the date of the last data capture.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    F.2 Gender
    F.2.1Female No
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 22
    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)
    Not applicable. Patients will receive treatment whilst on trial. Any further treatment needed for their penile disease will be given as part of standard care.
    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 Decision2013-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-06
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