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    Summary
    EudraCT Number:2010-023017-65
    Sponsor's Protocol Code Number:B1871019
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-20
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-023017-65
    A.3Full title of the trial
    A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease
    A.4.1Sponsor's protocol code numberB1871019
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01233869
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailClinicalTrials.govCallCentre@pfizer.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 nameBosutinib
    D.3.2Product code PF-05208763
    D.3.4Pharmaceutical form 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 INNBosutinib (anhydrous)
    D.3.9.1CAS number 380843-75-4
    D.3.9.2Current sponsor codePF-05208763
    D.3.9.3Other descriptive nameSKI-606
    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 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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    E.1.1.1Medical condition in easily understood language
    Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
     To demonstrate that bosutinib reduces the rate of kidney enlargement in subjects with
    autosomal dominant polycystic kidney disease (ADPKD) entering the study with total
    kidney volume (TKV) ≥750 cc and eGFR ≥60 mL/min/1.73m2.
     To identify a safe and efficacious dose of bosutinib to be utilized for subsequent
    studies.
    E.2.2Secondary objectives of the trial
     To investigate the effect of treatment with bosutinib on renal function compared with placebo.
     To determine the time to first occurrence (or worsening) of clinical measures of disease activity.
     To evaluate the plasma PK of bosutinib.
     To evaluate the effect of treatment with bosutinib on subject-reported, disease specific quality of life compared with placebo.
     To investigate the progression of eGFR over the course of the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2. Males and females, aged ≥18 years to 50 years at the time of consent.
    3. Documented diagnosis of ADPKD by renal ultrasound cyst criteria based on the Unified Criteria for Ultrasonographic Diagnosis of ADPKD. A family history of ADPKD is not required to support diagnosis by ultrasound criteria. Alternatively, the diagnosis of ADPKD may be based on PKD 1 or PKD 2 genotype findings as documented in the medical record.
    4. Total kidney volume ≥750 cc, as measured by centrally evaluated MRI.
    5. Left ventricular ejection fraction by echocardiogram or MUGA ≥50% at screening.
    6. All women of childbearing potential must have two negative pregnancy test results before administration of study drug. Women of childbearing potential must agree to use two highly effective methods of contraception as described in the protocol for at least 14 days prior to the first dose of study medication and continue until 28 days after dosing. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
    7. Men willing to use two highly effective methods of contraception as described in the protocol throughout the active treatment phase of the study and for 28 days after the last dose of study drug. Any pregnancy that occurs in the female partner of a male subject in the study must be reported if it occurs at any time during the active treatment phase of the study or for 28 days after the last dose of study drug.
    8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Weight <40 kg or >125 kg.
    2. Women who are pregnant or breastfeeding or women who intend to become pregnant in the next two years.
    3. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 for primary treatment population. Subjects with moderate renal impairment (defined as 30 mL/min/1.73m2 ≤ eGFR ≤50mL/min/1.73m2) are excluded (from enrollment in an exploratory population) until results from a separate renal impairment PK study (study B1871020) demonstrate no substantial impact of renal impairment on bosutinib PK. Subjects with an eGFR<30 mL/min/1.73m2 will be excluded.
    4. Abnormal urinalysis showing cellular casts.
    5. Biopsy proven renal disease other than ADPKD.
    6. Chronic back and/or flank pain requiring daily or near daily pain medication over the preceding month.
    7. Documented renal vascular disease.
    8. Documented systemic illness with renal involvement.
    9. Creatine supplements within 3 months of the baseline visit.
    10. Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg).
    11. Uncontrolled diabetes mellitus as evidenced by screening assessments and/or recent medical record.
    12. Medical history or diagnosis of immunodeficiency.
    13. Autoimmune disease not in remission or requiring ongoing treatment with immunosuppressive medication.
    14. Increased ALT and/or AST >2.5 x the upper limit of normal.
    15. Total bilirubin >2 x the upper limit of normal (unless associated with Gilbert’s syndrome).
    16. Grade 2 or higher abnormalities of serum sodium [sodium >150 or <130 mmol/l].
    17. Uncorrected hypomagnesemia or hypokalemia [serum magnesium or serum potassium < lower limit of normal].
    18. Grade 2 or higher elevation of serum potassium or serum magnesium [serum potassium >5.5 or serum magnesium >3.0 mg/dl (or >1.23 mmol/l)].
    19. Hemoglobin <9.0 gm/dl.
    20. Platelet count <100,000/microliter.
    21. Congenital absence of a kidney or prior surgical resection of a kidney for any reason.
    22. Clinically significant or unstable cardiac disease (eg, unstable angina, recent myocardial infarction, clinically significant arrhythmia requiring treatment, uncontrolled congestive heart failure, etc).
    23. Subjects with any pre dose corrected QT interval (QTc) ≥450 msec based on any one of the machine read tracing using Fridericia’s formulae obtained at screening. Any decision to retest a subject must first be discussed with the Pfizer Medical Monitor. If a repeat QTcF interval obtained pre-dose is ≥450 msec, the subject is excluded from enrollment.
    24. History of prolonged QTc interval or additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
    25. History or evidence of infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
    26. Past or present malignancy (with the exception of adequately treated, localized basal cell or squamous cell carcinoma of the skin).
    27. Use of any investigational drug or investigational biologic compound within 4 weeks prior to the screening visit or during the screening period.
    28. Participation in any interventional studies within 4 weeks prior to the screening visit and/or during study participation.
    29. Any previous exposure to the bosutinib study drug, including previous participation in a bosutinib clinical study, or receipt of other therapies intended to modify the progression of polycystic kidney disease (supportive care measures excepted).
    30. Contraindication(s) to undergoing magnetic resonance imaging (MRI).
    31. Mental illness that could interfere with the subject’s ability to comply with the protocol.
    32. Ongoing treatment with Digoxin.
    33. Ongoing treatment with strong P Glycoprotein inhibitors or inducers
    34. Ongoing treatment with strong CYP3A inhibitors.
    35. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
    36. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    • Annualized rate (%) of kidney enlargement relative to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    25 Months
    E.5.2Secondary end point(s)
    • The following clinical parameters to assess disease progression will be evaluated:
    • Rate of decline of estimated Glomerular Filtration Rate (eGFR) relative to placebo will be investigated.
    • Time to first occurrence or worsening of hypertension, defined as the need for increased dose of or need for additional anti hypertensive medication.
    • Time to first occurrence or worsening of back and/or flank pain.
    • Time to first occurrence of gross hematuria.
    • Time to first occurrence of proteinuria.
    • Onset of end stage renal disease requiring dialysis ≥56 days.
    • Renal function evaluations to include blood urea nitrogen and serum creatinine.
    • Pharmcokinetic parameters of bosutinib including Cmax, tmax, AUCtau, Cmin, Clearance, Vz/F, t1/2, and R.
    • Quality of Life measured by the Kidney Disease Quality of Life (KDQoL 36) questionnaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    25 Months
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA37
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Canada
    Czech Republic
    Hungary
    Italy
    Japan
    Korea, Democratic People's Republic of
    Lithuania
    Moldova, Republic of
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    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
    As per Protocol
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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: 190
    F.1.3Elderly (>=65 years) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 190
    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)
    There are no plans at this point for treatment or care after the subject has ended his/her participation.
    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 Decision2011-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-29
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