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    Summary
    EudraCT Number:2005-004230-40
    Sponsor's Protocol Code Number:B1871006
    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:2007-06-12
    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 number2005-004230-40
    A.3Full title of the trial
    A Phase 1/2 Study of SKI-606 in Philadelphia Chromosme Positive Leukemias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Study of SKI-606 in Philadelphia Chromosome Positive Leukemias
    A.3.2Name or abbreviated title of the trial where available
    CML study
    A.4.1Sponsor's protocol code numberB1871006
    A.5.4Other Identifiers
    Name:old study numberNumber:3160A4-200-WW
    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 SponsorWyeth Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA
    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 supportWyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA
    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 Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 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.govCallCenter@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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/160/09
    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
    D.3.9.2Current sponsor codePF-05208763
    D.3.9.3Other descriptive nameSKI-606 monohydrate
    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.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/160/09
    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
    D.3.9.2Current sponsor codePF-05208763
    D.3.9.3Other descriptive nameSKI-606 monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Philadelphia Chromosome positive leukemias occur as a result of a reciprocal translocation between chromosomes 9 and 22. Its most common phenotype is Chronic Myelogenous Leukemia (CML), which has three disease phases (chronic, accelerated and blast) of increasing leukemic blast count and clinical severity. Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) resembles blast phase CML in clinical severity.
    E.1.1.1Medical condition in easily understood language
    Blood cancer with chromosome translocation (9;22) which results in too many white blood cells in bone marrow and blood, some of which are immature (blasts).
    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 LLT
    E.1.2Classification code 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1 (Dose-escalation part): Part 1 of study is Completed
    - Define the maximum tolerated dose, less than or equal to 1000 mg/day, in subjects with CML in chronic phase resistant or refractory to imatinib
    - Evaluate the overall PK parameters in this population.

    Part 2 (Efficacy components):
    - Determine the rate of attaining major cytogenetic response in subjects entering with imatinib-resistant chronic phase CML, who have no prior Src, Abl, or Src-Abl kinase inhibitor exposure other than imatinib
    - Determine the population PK parameters of this population
    E.2.2Secondary objectives of the trial
    Part 2- Estimate:
    - Time to and duration of major cytogenetic response in subjects entering with imatinib-resistant chronic phase CML who have no prior Src, Abl, or Src/Abl kinase inhibitor exposure other than imatinib
    - MCyR rate in CP CML subjects intolerant of imatinib, who have no prior Src, Abl, or Src/Abl kinase inhibitor exposure other than imatinib
    - Time to and duration of major cytogenetic response in CP CML subjects intolerant of imatinib who have no prior Src, Abl, or Src/Abl kinase inhibitor exposure other than imatinib
    - Time to and duration of CHR in the imatinib-resistant and imatinib-intolerant groups
    - MCyR rate in CP CML subjects who have failed imatinib and are resistant to dasatinib (1); who have failed imatinib and are intolerant to dasatinib (2)
    - CHR rate in advanced leukemia subjects
    - Assess safety of SKI-606 during prolonged oral exposure in a leukemic population
    - Explore overall survival and progression free survival rates at 1 and 2 yrs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures.
    2. Cytogenetic or PCR based diagnosis of any phase of Ph+ CML or Ph+ ALL whose disease is resistant to full-dose imatinib (>/=600mg), or are intolerant of any dose of imatinib.
    3. Adequate duration of prior imatinib therapy (See section 10.1.2)
    4. ECOG Performance Status of 0 or 1 for chronic phase subjects, and 0, 1 or 2 for Advanced Stage subjects.
    5. At least 7 days since any anti-proliferative treament, (except hydroxyurea and anagrelide - see Concomitant treatment - Permitted Medications, for details)
    6. Recovered to Grade 0-1, or to baseline, from any toxicities of prior treatment, other than alopecia
    7. At least 3 months post allogeneic stem cell transplantation
    8. Able to take daily oral capsules reliably
    9. Adequate bone marrow function (Chronic Phase subjects only) - Part 1 only)
    a. Absolute neutrophil count > 1000/mm^3 (>1000x10^9/L)
    b. Platelets >/= 100,000/mm^3 (>100 x 10^9/L), absent any platelet transfusions during the preceding 14 days
    10. Adequate hepatic, and renal function
    a. AST/ALT </= 2.5 x upper limit of normal (ULN) or </= 5 x ULN if attributable to liver involvement of leukemia
    b. Total bilirubin </= 1.5 x ULN
    c. Creatinine </= 1.5 x ULN
    11. Age >/= 18 years
    12. Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of SKI-606
    13. Documented normal INR if not on oral anticoagulant therapy (OAT), or if no OAT consistent target INR</= 3.
    E.4Principal exclusion criteria
    1. Subjects with Philadelphia chromosome and bcr-abl negative CML.
    2. Subjects previously intolerant of imatinib - Part 1 (dose escalation only)
    3. Overt leptomeningeal leukemia. Subjects must be free of CNS involvement for a minimum of 2 months. Subjects with CNS symptoms must have a diagnostic lumbar puncture prior to study enrolment.
    4. Subjects with extramedullary disease only
    5. In part 1, no prior exposure to Src, Abl, or Src/Abl kinase inhibitors is allowed.
    6. Ongoing requirement for warfarin or other OAT (Part 1 only)
    7. Ongoing requirement for hydroxyurea or anagrelide (Part 1 only)
    8. Graft Versus Host Disease (GVHD)
    a. part 1 - no previous GVHD allowed
    b. Part 2 - no treated or untreated GVHD within 60 days of study start
    9. Major surgery within 14 days or radiotherapy within 7 before the first dose of SKI-606 (recovery from any previous surgery should be complete before day 1)
    10. Ongoing clinical requirement for administration of a strong inhibitor of CYP-3A4 (See attachment 3) - Part 1 only
    11. A history of a clinically-significant ventricular arrhythmia, congenital or acquired prolonged QT interval, a baseline QTcF > 0.47 sec (average of triplicate readings) or unexplained syncope, uncontrolled or symptomatic congestive heart failure (CHF) within 3 months, or myocardial infarction (MI) within 6 months.
    12. Concomitant use of or need for medications known to prolong the QT interval (see attachment 4)
    13. Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
    14. Recent (within 30 days of study entry) or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, short bowel syndrome, bleeding or Grade >1 diarrhea, nausea or emesis lasting more than 2 days, despite adequate medical therapy)
    15. Pregnant or breastfeeding women
    16. Evidence of serious active infection, or significant medical or psychiatric illness
    17. Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, hypokalemia (anygrade), or clinically significant abnormal laboratory finding that would, in the investigator's judgment, make the subject imappropriae for this study.
    E.5 End points
    E.5.1Primary end point(s)
    SAFETY
    -Incidence and severity of dose-limiting toxicities (DLTs) at each dose level
    -Incidence, severity and duration of adverse events at each dose level and for all subjects combined
    EFFICACY
    - MCyR rate in imatinib resistant chronic phase patients, who have no prior Src, Abl, or Src-Abl inhibitor exposure other than imatinib, who have completed at least 24 weeks of treatment, or obtained MCyR prior to 24 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    When MTD occurs in Phase 1 and then ongoing during the study based on cumulative data. For details see protocol.
    E.5.2Secondary end point(s)
    SAFETY
    - Changes in laboratory test results, inlcuding electrocardiogram (ECG), and chest x-ray.
    -Concomitant medications used for management of AEs
    - Changes in ECOG performance score or physical examination
    EFFICACY
    - Disease-phase-appropriate hematologic and cytogenetic endpoint assessments (MCyR for chronic phase and CHr or OHR for advance leukemia patients)
    - Overall survival (OS) and progression free survival (PFS) rates at 1 and 2 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    ongoing during the study based on cumulative data and MCyR rates at 24 weeks and OHR rate in imatinib-resistant accelerated phase and blast phase CML subjects at 48 weeks. For details see protocol.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose response
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Argentina
    Australia
    Austria
    Brazil
    Canada
    Chile
    China
    Colombia
    Finland
    Germany
    Hong Kong
    Hungary
    India
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Norway
    Peru
    Russian Federation
    Singapore
    South Africa
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    Last visit of the last patient undergoing the trial (Please refer to protocol)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    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 months4
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 551
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 128
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 679
    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)
    Please refer to Protocol.
    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 Decision2007-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-30
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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