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    Summary
    EudraCT Number:2012-002962-11
    Sponsor's Protocol Code Number:IQUO/01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002962-11
    A.3Full title of the trial
    Optimizing Pazopanib Exposure in RCC Patients through Therapeutic Drug Monitoring Followed by Intrapatient Dose Escalation
    Optimierung der Pazopanib Exposition bei Patienten mit Nierenzellkarzinom durch therapeutische Arzneimittelkontrolle gefolgt von intraindividueller Dosisanpassung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimisation of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic Drug Monitoring followed by Individual Dose Escalation
    Optimierung der Pazopanib Exposition bei Patienten mit Nierenzellkarzinom durch therapeutische Arzneimittelkontrolle gefolgt von intraindividueller Dosisanpassung
    A.3.2Name or abbreviated title of the trial where available
    OPERA
    A.4.1Sponsor's protocol code numberIQUO/01
    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 SponsorInteressenverband zur Qualitätsicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland (IQUO) e.V.
    B.1.3.4CountryGermany
    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 supportGlaxoSmithKline GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOnkoDataMed GmbH
    B.5.2Functional name of contact pointCRO - Clinical Research Organisatio
    B.5.3 Address:
    B.5.3.1Street AddressFriedenstr. 58
    B.5.3.2Town/ cityNeuenhagen
    B.5.3.3Post code15366
    B.5.3.4CountryGermany
    B.5.4Telephone number+49334242 689 10
    B.5.5Fax number+49334242 689 20
    B.5.6E-mailandrea.lockner@onkodatamed.de
    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 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    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.3.2Product code GW786034
    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 635702-64-6
    D.3.9.4EV Substance CodeSUB31270
    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.IMP: 2
    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 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    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.3.2Product code GW786034
    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 635702-64-6
    D.3.9.4EV Substance CodeSUB31270
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Renal cell carcinoma
    E.1.1.1Medical condition in easily understood language
    Cancer of the kidney.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine if in patients with a Pazopanib plasma trough level of ≤ 20 μg/mL a plasma trough level of > 20 ≤g/mL can be achieved by dose escalation.
    E.2.2Secondary objectives of the trial
    - Comparison of patients with normal Pazopanib plasma trough levels (“normal plasma level patients; NPLP) with patients with low Pazopanib plasma trough levels (“Low plasma level patients”; LPLP) with regard to the therapeutic result:
    - objective remission rate
    - progression free survival
    - overall survival
    - comparison of LPLP in whom the plasma trough level could be optimized successfully and LPLP in whom the plasma trough level could not be optimized with regard to above parameters
    - Correlation of plasma trough levels and side effects, especially high blood pressure
    - Correlation of the occurrence of high blood pressure with oncological result (response rate)
    - Recording of demographic data, compliance, concomitant medication, and correlation with plasma trough levels (LPLP / NPLP)
    - Examination of life quaility
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - signature of informed consent
    - age ≥ 18 years
    - histologically confirmed renal cell carcinoma with clear cell component and either locally progressed or metastasized
    - ECOG ≤ 2
    - No previous systemic therapy for locally progressed or metastasized renal cell carcinoma (previous adjuvant or neo-adjuvant therapy is permitted)
    - Adequate organ function
    - Female patients with child-bearing potential with negative serum pregnancy test within 2 weeks prior to first dose of study medication and adequate contraception
    - Lactating females
    E.4Principal exclusion criteria
    - Clinically suspected and known metastases of the central nervous system or meningeosis carcinomatosis except in asymptomatic patients with previously treated CNS-metastases and no necessity of steroids or anti-epileptic medication ≥ 6 months prior to start of the study medication
    - Clinically significant gastrointestinal conditions with risk of increase of gastrointestinal bleeding due to (but not limited to)
    - active peptic ulceration
    - known intraluminal metastases with risk of bleeding
    - chronic-inflammatory intestinal disease (like Morbus Crohn, colitis ulcerosa) or another gastrointestinal disease with increased risk of perforation
    - abdominal fistulas in anamnesis
    - Clinically significant gastrointestinal conditions which can influence absorption of the IMP, among others (but not limited to)
    - malabsorption syndrome
    - resection of stomach or small bowel
    - Current uncontrolled infection
    - QTc corrected for heart frequency according to the Bazett formula
    - One or more of the following cardiovascular diseases within the last 6 months in the anamnesis:
    - cardiac angioplasty or coronary stent implantation
    - myocardial infarction
    - instable angina pectoris
    - coronary-arterial bypass surgery
    - symptomatic peripheral arterial occlusive disease
    - Heart failure NYHA III or IV
    - Poorly controlled high blood pressure
    - Cerebrovascular disease, including transitory ischemic attacks, pulmonary artery embolism or untreated deep vein thrombosis within 6 months of study inclusion
    - Previous major surgery or traumas within 28 days prior to start if study treatment or non-healing wound, fracture or ulcer
    - Clinical signs of active bleeding or bleeding diathesis
    - Known endobronchial lesions or lesions infiltrating the large lung arteries
    - Haemoptyses of > 2.5 mL within 8 weeks prior to first intake of study medication
    - Any other severe and/or instable medical or psychiatric pre-existing or other condition influencing patient safety, consent capacity or compliance within the study
    - Incapacity or rejection to stop not allowed medication prior to first intake of study drug and pause for the duration of the trial
    - Treatment with one of the following anti-tumour therapies:
    - Radiation or tumour embolism within 14 days before first intake of study drug
    - Chemotherapy, Immunotherapy, biological therapy, study medication or hormonal therapy within 14 days or 5 half-lives of the respective substance (whichever is longer) before first intake of the study drug. Neo-adjuvant or adjuvant therapy must have been completed for at least 6 months.
    - Any present toxicity > CTC 1° from prior anti-tumour therapy and/or toxicities worsening in severity except alopecia
    E.5 End points
    E.5.1Primary end point(s)
    Fraction of LPLPs who achieve a plasma trough level of > 20 µg/mL by dose optimization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after treatment start and 14 days after each dose optimization.
    E.5.2Secondary end point(s)
    - Objective response rate, defined as complete or partial remission lasting ≥ 4 weeks (determined according to RECIST criteria version 1.1)
    - Progression free survival, defined as the time between study registration and disease progression (determined according to RECIST criteria version 1.1) or death during the study (defined as death during treatment or within 30 days after end of treatment)
    - Overall survival, defined as the time between study registration until death (for any reason)
    - Descriptive comparison of the therapeutic response (objective response rate, progression free survival, overall survival) of LPL and NPL patients
    - Correlation of plasma trough level and side effects, especially high blood pressure
    - Correlation of the occurrence of high blood pressure with therapeutic response
    - Recording of demographic data, compliance, concomitant medication and correlation with plasma trough levels
    - Examination of life quality, measured by EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days after the last patient completed study treatment.
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    intraindividual dose optimization
    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.8.2.4Number of treatment arms in the trial2
    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 concerned30
    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 the study is defined when the follow-up observation of the last patient is completed, and at the latest 30 months after registration of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state100
    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)
    The further treatment of patients who have completed study treatment will be in accordance with the medical standard.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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