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    Summary
    EudraCT Number:2006-004693-27
    Sponsor's Protocol Code Number:A6181064
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-10-10
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-004693-27
    A.3Full title of the trial
    A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS
    A.4.1Sponsor's protocol code numberA6181064
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Ltd
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 nameSutent
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNsunitinib malate
    D.3.9.1CAS number 341031-54-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12.5 to 50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma SA
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNdocetaxel
    D.3.9.1CAS number 1327-53-3.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 80
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Advanced breast cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    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 the combination of docetaxel with sunitinib is superior to docetaxel in prolonging PFS in patients with advanced breast cancer.
    E.2.2Secondary objectives of the trial
    To compare the clinical benefit in patients treated with the 2 regimens.
    To compare the safety of the 2 regimens.
    To compare the patient reported outcomes of patients treated with the 2 regimens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically proven diagnosis of breast cancer with evidence of
    1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent
    disease must not be amenable to resection or radiation therapy with curative intent.
    2. Her-2 negative breast cancer (i.e., FISH or CISH (where approved) negative or
    immunohistochemistry 0 or +1).
    3. Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST)
    or bone-only disease.
    4. The following patients are eligible:
    • Patients not candidate for adjuvant chemotherapy at first diagnosis who
    relapsed with distant metastases
    • Patients candidate for adjuvant or neo-adjuvant hormonal therapy at first
    diagnosis who relapsed with distant metastases.
    • Patients candidate for adjuvant or neo-adjuvant cytotoxic therapy at first
    diagnosis who relapsed with locally advanced or metastatic disease
    • If adjuvant or neo-adjuvant therapy included also a taxane, relapse
    must have occurred ≥12 months since completion of chemotherapy.
    • Hormonal therapy concurrent or sequential to adjuvant chemotherapy
    is allowed.
    • Hormonal therapy for advanced disease is allowed but is to be discontinued
    prior to the start of study treatment.
    • Patients with bone-only disease that are hormone receptor-positive must have
    progressed during or after hormone therapy prior to entering the trial.
    5. Must be candidate for treatment with docetaxel.
    6. May have received prior radiation therapy. A measurable lesion that has been
    previously irradiated will be evaluated only when it increases in size. Radiotherapy
    is to be completed prior to screening disease assessments.
    7. Female, 18 years of age or older.
    8. ECOG performance status 0 or 1.
    9. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade
    ≤1 (except alopecia or other toxicities not considered a safety risk for the patient).
    10. Adequate organ function as defined by the following criteria:
    • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤1.5
    x upper limit of normal (ULN), or AST and ALT ≤2.5 x ULN if liver function
    abnormalities are due to underlying malignancy.
    • Deleted in Amendment 2 (Alkaline phosphatase (ALP) ≤2.5 x ULN).
    • Total serum bilirubin <1 x ULN. [patients suffering from Gilbert’s disease are
    allowed to enter the study]
    • Serum albumin ≥2.5 g/dL.
    • Absolute neutrophil count (ANC) ≥1500/µL.
    • Platelets ≥100,000/µL.
    • Hemoglobin ≥8.5 g/dL.
    • Serum creatinine ≤1.5 x ULN.
    • Left ventricular ejection fraction (LVEF) ≥50% as measured by either multigated
    acquisition (MUGA) scan or echocardiogram (ECHO).
    11. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
    12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Clinical presentation of inflammatory carcinoma with no other measurable disease.
    2. Prior treatment with chemotherapy in the metastatic disease setting.
    3.Prior treatment on a sunitinib clinical trial.
    4. Patients for whom docetaxel is contraindicated according to the local prescribing
    information.
    5. History of severe hypersensitivity reactions to docetaxel or to other drugs
    formulated with polysorbate 80.
    6. AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN.
    7. Major surgery, or systemic therapy (with the exception of hormonal therapy) within
    3 weeks of start of study treatment. At least 1 week should elapse since minor
    surgical procedures including placement of an access device or fine needle
    aspiration.
    8. Deleted in Amendment 2 (Prior high-dose chemotherapy requiring hematopoietic
    stem cell rescue).
    9. Deleted in Amendment 2 (Prior radiation therapy to >25% of the bone marrow).
    10. Current treatment on another clinical trial.
    11. History or presence of brain metastases, presence of spinal cord compression, or
    carcinomatous meningitis, or leptomeningeal disease.
    12. Diagnosis of any second malignancy within the last 3 years, except for adequately
    treated basal cell carcinoma or squamous cell skin cancer or in situ carcinoma of
    the cervix uteri.
    13. Any of the following within the 6 months prior to starting study treatment:
    myocardial infarction, severe/unstable angina, congestive heart failure,
    cerebrovascular accident including transient ischemic attack, or pulmonary
    embolus.
    14. Ongoing cardiac dysrhythmias of grade ≥2, or QTc interval >470 msec.
    15. Hypertension that cannot be controlled by medications (>150/100 mmHg despite
    optimal medical therapy).
    16. Current treatment with therapeutic doses of coumarin derivatives such as warfarin and phenprocoumon (low dose for deep vein thrombosis prophylaxis is allowed) or oral anti-vitamin K agents. Treatment with therapeutic doses of low-molecularweight heparin is allowed.
    17. Known human immunodeficiency virus infection.
    18. Pregnancy or breastfeeding. Female patients who are pregnant or nursing, female of child-bearing potential who is unwilling or unable to use adequate contraception to prevent pregnancy during the trial and for 3 months after the last dose of study treatment. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry.
    19. Other severe acute or chronic medical or psychiatric condition, or laboratory
    abnormality that would impart, in the judgment of the investigator, excess risk
    associated with study participation or study drug administration, or which, in the
    judgment of the investigator, would make the patient inappropriate for entry into
    this study. Prior treatment on a sunitinib clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient Reported Outcome
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient patients have been recruited and completed the trial as stated in the regulatory application (i.e., Clinical Trial Application (CTA)) and ethics application in the Member State.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 550
    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)
    Patients should continue to be evaluated for 28 calendar days after the last dose of study drug (sunitinib and/or docetaxel). Patients discontinuing both agents prior to PD will be followed for tumour assessment until PD, or until the initiation of subsequent anti-cancer therapy in the absence of documented PD, or until death, whichever occurs first.
    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 Decision2006-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-15
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