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    Summary
    EudraCT Number:2012-005161-12
    Sponsor's Protocol Code Number:OAS-12DOC-BIO
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-08-17
    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 ConcernedLatvia - SAM
    A.2EudraCT number2012-005161-12
    A.3Full title of the trial
    A multi-country, multicenter, randomized, open-label, parallel group study to assess the efficacy and safety of Docecal compared with Taxotere®
    Starptautisks, daudzcentru, randomizēts, atklāts, paralēlu grupu pētījums, lai novērtētu Docecal efektivitāti un drošumu salīdzinājumā ar Taxotere®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-country, multicenter, randomized, open-label, parallel group study to assess the efficacy and safety of Docecal compared with Taxotere®
    Starptautisks, daudzcentru, randomizēts, atklāts, paralēlu grupu pētījums, lai novērtētu Docecal efektivitāti un drošumu salīdzinājumā ar Taxotere®
    A.4.1Sponsor's protocol code numberOAS-12DOC-BIO
    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 SponsorOasmia Pharmaceutical AB
    B.1.3.4CountrySweden
    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 supportOasmia Pharmaceutical AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOasmia Pharmaceutical AB
    B.5.2Functional name of contact pointOasmia Pharmaceutical AB
    B.5.3 Address:
    B.5.3.1Street AddressVallongatan 1
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post codeSE-752 28
    B.5.3.4CountrySweden
    B.5.6E-mailmargareta.eriksson@oasmia.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 nameDocecal
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 114977-28-5
    D.3.9.3Other descriptive nameANHYDROUS DOCETAXEL
    D.3.9.4EV Substance CodeSUB22289
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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 S.A.
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    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 nameTaxotere
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 114977-28-5
    D.3.9.3Other descriptive nameANHYDROUS DOCETAXEL
    D.3.9.4EV Substance CodeSUB22289
    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) 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
    adenocarcinoma of the breast
    E.1.1.1Medical condition in easily understood language
    breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10006198
    E.1.2Term Breast cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate that Docecal is not inferior to Taxotere®, measured as overall response rate (ORR).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To assess the efficacy of Docecal compared with Taxotere® as measured by secondary efficacy endpoints.
    • To assess the safety profile of Docecal compared with Taxotere®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    Only patients to whom all of the following conditions apply will be included in the study:
    1. Signed informed consent.
    2. Women 18 years or older with histologically confirmed adenocarcinoma of the breast and:
    a. disease progression after one prior anthracycline chemotherapy regimen for locally advanced or metastatic breast cancer, or
    b. disease progression during or within 12 months of completing an adjuvant or neoadjuvant anthracycline chemotherapy regimen for locally advanced or metastatic breast cancer.
    3. Prior chemotherapy completed at least 3 weeks before randomization (with the exception of oral cyclophosphamide [2 weeks] and nitrosureas or mitomycin [6 weeks]). Prior hormonal therapy in the adjuvant and/or metastatic setting is allowed if completed immediately before study entry.
    4. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions). Measurable tumour lesions are defined as those with a minimum size of 10 mm by CT scan (or no less than twice the slice thickness for scanners with slice thickness > 5 mm). To be considered pathologically enlarged and measurable, a lymph node must be ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm).
    5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    6. Adequate haematological, hepatic and renal function defined as:
    a. Neutrophils ≥ 1.5 × 109/L,
    b. Platelets ≥ 100 × 109/L,
    c. Total serum bilirubin ≤ 1 UNL ,
    d. ASAT and ALAT ≤ 2.5 UNL,
    e. Alkaline phosphatase ≤ 5 UNL,
    Patients with ASAT and/or ALAT >1.5 UNL associated with alkaline phosphatase > 2.5 UNL are not eligible for the study.
    f. Serum creatinine ≤ 2 mg/dL.
    7. Negative urine pregnancy test for female patients of childbearing potential.
    8. Women of childbearing potential must agree to use adequate method of contraception for the duration of study treatment and for 6 months after the last dose of study drug.
    9. Ability and willingness of the patient to follow all requirements of the study protocol.
    E.4Principal exclusion criteria
    Exclusion criteria:
    Patients to whom any of the following conditions apply must be excluded from the study:
    1. Known brain metastases/leptomeningeal involvement.
    2. History of hypersensitivity reaction to products containing docetaxel, polysorbate 80 or XMeNa.
    3. Definite contraindications for the use of dexamethasone: hypersensitivity to any component of dexamethasone drug formulation, severe infectious diseases.
    4. History of significant neurologic or psychiatric disorders including dementia or seizures.
    5. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
    6. Peripheral neuropathy of Grade 2 or higher (NCI-CTCAE, Version 4.0) at randomization.
    7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    8. Concurrent treatment with any other anti-cancer therapy.
    9. Prior treatment with taxanes, bone marrow transplantation or stem-cell support.
    10. Radiotherapy within 4 weeks prior to screening.
    11. Surgery within 2 weeks prior to screening.
    12. Participation in other clinical trial with any investigational drug within 30 days prior to enrolment or during participation of the current study.
    13. Pregnant or lactating women.
    14. Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of study drugs.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: The primary efficacy endpoint is overall response rate (partial and complete response) after 6 cycles of chemotherapy, based on the assessments of the Independent Imaging Review Facility (IRF) according to RECIST 1.1 criteria (2009).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint is overall response rate (partial and complete response) after 6 cycles of chemotherapy, based on the assessments of the Independent Imaging Review Facility (IRF) according to RECIST 1.1 criteria (2009).
    E.5.2Secondary end point(s)
    Secondary endpoints:
    Secondary efficacy endpoints are:
    • Disease control rate
    • Time to response
    • Duration of response
    • Progression free survival
    • Time to progression
    • Quality of life using the Functional assessment of cancer therapy measurement system for breast cancer (FACT-B)

    Safety endpoints are:
    • Incidence and nature of adverse events
    • Incidence of events considered to be hypersensitivity reactions
    • Incidence of events interpreted as fluid retention
    • Changes in physical examination
    • Changes in vital signs (body temperature, pulse rate, systolic and diastolic blood pressure)
    • Changes in electrocardiogram
    • Changes in laboratory tests (haematology, biochemistry, urinalysis)
    • Change in ECOG status
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Disease control rate - a complete response , partial response or stable disease determined by the IRF using RECIST 1.1 criteria.
    • Time to response is measured from time of randomization to the time measurement criteria are first met for CR/PR.
    • Duration of response is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.
    • Progression free survival - time of randomization until disease progression or death.
    • Time to progression - time interval between the date of randomization and the date of disease progression.
    • Quality of life (QOL) using the FACT-B - global QOL score based on the Functional Assessment of Cancer Therapy measurement system for breast cancer (FACT-B) completed by the patient.
    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 Yes
    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) 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 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) Yes
    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 concerned2
    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 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
    Russian Federation
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 35
    F.4.2.2In the whole clinical trial 235
    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)
    None
    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 Decision2015-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-05-15
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