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    Summary
    EudraCT Number:2011-003226-27
    Sponsor's Protocol Code Number:RG_10-151
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-07-30
    Trial 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 number2011-003226-27
    A.3Full title of the trial
    A Phase II Study of Pazopanib in Metastatic Merkel Cell Carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study of Pazopanib in Metastatic Merkel Cell Carcinoma (called UKMCC-01)
    A.3.2Name or abbreviated title of the trial where available
    UKMCC-01, Version 1.0, 01-Jun-2012
    A.4.1Sponsor's protocol code numberRG_10-151
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN10125877
    A.5.4Other Identifiers
    Name:CRCTU NoNumber:SK2006
    Name:SAFNumber:ERN_11-1282
    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 Birmingham
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity ofBirmingham
    B.5.2Functional name of contact pointSarah Bowden
    B.5.3 Address:
    B.5.3.1Street AddressCancer Research UK Clinical Trials Unit (CRCTU)
    B.5.3.2Town/ cityBirmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0121 414 4371
    B.5.5Fax number0121 414 8392
    B.5.6E-mailUKMCC-01@trials.bham.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 Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    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 namePazopanib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPazopanib hydrochloride
    D.3.9.1CAS number 635702646
    D.3.9.3Other descriptive nameVotrient
    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 number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Merkel Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Cancer of the skin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029266
    E.1.2Term Neuroendocrine carcinoma of the skin
    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 main objective of the UKMCC-01 study is to find out whether treatment with a drug called pazopanib is beneficial for patients with advanced MCC and thus warrants further investigation in a large, randomised, phase III trial. Advanced MCC patients have a poor prognosis and new treatment options for this group are desperately needed.
    To assess whether pazopanib works we will determine the number of patients whose tumours disappear or reduce in size during treatment (technically called Clinical Response Rate).
    E.2.2Secondary objectives of the trial
    Secondary research objectives include determining:
    • How many patients have stable disease or an improvement in their disease for more than 12 weeks (technically called Disease Control Rate).
    • How long the patient’s response to treatment lasts (technically called Response to Treatment).
    • How long patients survive before their disease gets worse (technically called Progression Free Survival).
    • How long patients survive overall (technically called Overall Survival).
    In addition, a tissue bank will be established to allow scientists to study blood and tumour samples from patients with MCC in order to understand how this rare cancer works, this will help researchers develop new treatments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with histologically proven, unresectable, MCC that is metastatic and/or for which durable control cannot be achieved with surgery or radiotherapy
    • RECIST measurable disease, as per RECIST version 1.1
    • Age ≥18 years
    • Performance status 0, 1 or 2 assessed using the Eastern Cooperative Oncology Group scale
    • Received previous first line chemotherapy or considered unsuitable for chemotherapy
    • Toxicities from first line chemotherapy resolved to at least grade 1
    • Adequate end organ function
    o Renal function tests:
    - Serum creatinine ≤150 µmol/L. If serum creatinine >150 µmol/L, calculated creatinine clearance must be ≥30 ml/min
    - Urine Protein to Creatinine ratio (UPC) <1. If UPC ≥1, then a 24-hour protein must be assessed. Patients must have 24-hour protein value <1 g to be eligible. Alternatively, Albumin/Creatinine ratio may be measured (in accordance with institutional policy, same test to be used for study duration).
    o Liver function tests:
    - Total serum bilirubin ≤1.5 X Upper Limit Normal (ULN)
    - Alanine Aminotransferase or Aspartate Aminotransferase (in accordance with institutional policy, same test to be used for study duration) ≤2.5 X ULN (or ≤5 X ULN if liver metastases are present)
    o Haematology:
    - Absolute Neutrophil Count (ANC) ≥1.5 X 109/L
    - Haemoglobin ≥10 g/dL
    - Platelets ≥100 X 10 to the power of 9/L
    o Coagulation test:
    - International Normalized Ratio ≤1.2 X ULN, unless on therapeutic anti-coagulation. For patients on therapeutic anti-coagulation, INR should be stable and in target range.
    • Able to give written informed consent
    • Women of child-bearing potential, or men in a relationship with a woman of child- bearing age, prepared to adopt adequate contraceptive measures if sexually active
    • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
    E.4Principal exclusion criteria
    • Previous malignancies. (Unless agreed in writing by the Chief Investigator or a clinical Co-investigator, investigators are advised to call the Trial Office).
    • Known brain metastases unless radically treated with surgery or radiotherapy >6 months prior to study entry and without evidence of central nervous system progression since treatment
    • History in the past 6 months of cerebral or clinically significant gastrointestinal haemorrhage
    • Haemoptysis within 6 weeks prior to first dose of study medication
    • Evidence of active bleeding or bleeding diathesis
    • Uncontrolled hypertension defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg. Initiation or adjustment of antihypertensive medication(s) is permitted prior to trial entry
    • Presence of uncontrolled infection
    • History of malabsorption, major gastrointestinal tract resection or other pathology likely to affect absorption of study medication
    • Prolongation of the QT interval (QTc) >480 milliseconds
    • History of any one or more of the following cardiovascular conditions within the past 6 months:
    - Cardiac angioplasty or stenting
    - Myocardial infarction
    - Unstable angina
    - Coronary artery by-pass graft surgery
    - Symptomatic peripheral vascular disease
    - Class III or IV congestive heart failure, as defined by the New York Heart Association Functional Classification
    • History of cerebrovascular accident including transient ischemic attack within the past 12 months
    • History of pulmonary embolism or untreated deep venous thrombosis within the past 6 months. Patients with a history of thrombo-embolic disease who are on treatment with therapeutic anticoagulating agents are eligible
    • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
    • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drug chemically related to pazopanib
    • Major surgery or trauma <4 weeks prior to starting study medication and/or presence of any non-healing wound, fracture, or ulcer
    • Radiotherapy <2 weeks prior to starting study medication
    • Known HIV, Hepatitis B or C infection
    • Pregnant (female patients of child bearing potential should have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to trial entry)
    • Lactating females. Patients who agree to discontinue nursing 14 days prior to commencing treatment and do not nurse throughout all the treatment period are eligible
    • The use of the following medication is prohibited:
    - Previous therapy with agents that target the Vascular Endothelial Growth Factor (VEGF) or Platelet-derived Growth Factor (PDGF) pathways
    - Chemotherapy, immunotherapy, biologic therapy, investigational therapy, hormone therapy or use of any prohibited medications within 14 days prior to the first dose of study medication
    - Use of drugs which are known strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study medication
    • Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient’s safety, obtaining informed consent or compliance to the study
    • Other contraindications to study medication
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response rate: defined as the proportion of patients with complete response (CR) or confirmed partial response (PR) relative to the total number of patients recruited. Response will be determined using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome measure will first be analysed when 19 patients have been recruited. If one or more responses (complete or partial) have already been observed the trial will automatically continue to the next stage.
    The main analysis will be performed when all surviving patients have been followed up for 6 months.
    E.5.2Secondary end point(s)
    • Disease control rate: defined as the percentage of patients who have stable
    disease, a PR, or a CR for more than 12 weeks.
    • Progression free survival: defined as the time from entry into the trial until
    disease progression or death from any cause. Patients not having died or
    progressed will be censored at the date last seen alive.
    • Duration of response: defined as the time from date of first response (partial or
    complete) to date of progression or death from any cause.
    • Overall survival defined as the time from entry into the trial until death from
    any cause. Patients will be censored at the date last seen alive. All patients
    will be followed up until death or for a maximum of 5 years.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The first main analysis will be performed when all surviving patients have been followed up for 6 months. A further analysis will be conducted when all surviving patients have been followed up for 5 years or until death (which ever is sooner).
    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 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 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 concerned11
    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 will be 6 months after the last data capture. This will allow sufficient time for the completion of protocol procedures, data collection and data input. The UKMCC-01 Trial Office will notify the MHRA and REC that the trial has ended and will provide them with a summary of the clinical trial report within 12 months of the end of trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 10
    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 state25
    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)
    Treatment with pazopanib will continue until disease progression, defined as described in the RECIST criteria, death or unacceptable toxicity. Patients who experience disease progression may continue on the treatment or receive best supportive care at the investigator's discretion. Patients who continue treatment beyond tumour progression will be monitored within the study as per the trial assessment schedule.
    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 Decision2012-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-02
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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