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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-006344-19
    Sponsor's Protocol Code Number:D1532C00006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-006344-19
    A.3Full title of the trial
    Ensayo fase II, doble ciego, aleatorizado para evaluar la eficacia de AZD6244 (hidrógeno-sulfato) combinado con dacarbazina, en comparación con dacarbazina sola, como tratamiento de primera línea en pacientes con melanoma cutáneo o melanoma primario desconocido avanzado y mutación positiva de BRAF

    A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma
    A.4.1Sponsor's protocol code numberD1532C00006
    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 SponsorAstraZeneca 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 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 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 nameAZD6244
    D.3.2Product code AZD6244
    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.3.9.1CAS number 943332-08-9
    D.3.9.2Current sponsor codeAZD6244
    D.3.9.3Other descriptive nameAZD6244
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 Information not present in EudraCT
    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 nameDacarbazine
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNDacarbazine
    D.3.9.1CAS number 4342-03-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 600
    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 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 placeboCapsule, hard
    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
    melanoma cutáneo o melanoma primario desconocido avanzado y mutación positiva de BRAF

    BRAF mutation positive advanced cutaneous and unknown primary melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025654
    E.1.2Term Malignant melanoma of sites other than skin
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027152
    E.1.2Term Melanoma of skin (malignant)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027480
    E.1.2Term Metastatic malignant melanoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy in terms of Overall Survival (OS) of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma
    E.2.2Secondary objectives of the trial
    -To further assess the efficacy of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma
    - To assess the safety and tolerability profile of AZD6244 in combination with dacarbazine
    - To investigate the use of plasma and serum as a potential source of circulating free tumour DNA (CFDNA) for the analysis of BRAF mutation status
    - To investigate the pharmacokinetics of AZD6244 and N-desmethyl AZD6244 when AZD6244 is administered in combination with dacarbazine
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Host Genetic research sub-study: included in the main protocol
    Objective: To collect and store DNA, derived from a blood sample, for future exploratory research into genes that may influence response e.g. distribution, safety, tolerability and efficacy of AZD6244 and/or agents used in combination and/or as comparators

    - Optional Biomarker Research sub-study: included in the main protocol
    Objective: To explore potential biomarkers in residual tumour, plasma and/or serum, taken for BRAF mut
    E.3Principal inclusion criteria
    1. Provision of signed, written and dated informed consent prior to any study specific procedures
    2. Male or female, aged 18 years or older
    3. Histological or cytological confirmation of advanced cutaneous or unknown primary melanoma
    4. WHO performance status 0-1
    5. At least one lesion, not previously irradiated, that can be accurately measured at
    baseline as higher or equal to 10 mm in the longest diameter (LD; except lymph nodes which must
    have a short axis higher or equal to 15 mm) with CT or MRI, and which is suitable for accurate
    repeated measurements
    6. Tumour sample confirmed as BRAF mutation positive (Note: sample must be available upon enrolment to ship to the AstraZeneca appointed central laboratory, or mutation status confirmed locally at an AstraZeneca approved local laboratory
    using agreed methodology
    7. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Post-menopausal status is defined as:
    - natural menopause with menses >1 year ago
    - radiation-induced oophorectomy with last menses >1 year ago
    - chemotherapy-induced menopause with 1 year interval since last menses
    - serum FSH, LH and plasma oestradiol levels in the postmenopausal range for
    the institution
    - bilateral oophorectomy or hysterectomy
    8. Serum creatinine clearance >50 ml/min, by either Cockcroft-Gault formula or 24-hour urine collection analysis
    9. Patients should be able to swallow AZD6244/placebo capsules.
    E.4Principal exclusion criteria
    1. Involvement in the planning and/or conduct of the study (applies to both
    AstraZeneca staff and/or staff at the study site)
    2. Previous randomization of treatment in the present study
    3. Having received an investigational drug within the 30 days prior to entry, or have
    not recovered from side effects of an investigational drug
    4. Diagnosis of uveal or mucosal melanoma
    5. Any prior Investigational therapy comprising inhibitors of Ras, Raf or MEK
    6. Any prior cytotoxic chemotherapy or biochemotherapy for advanced melanoma
    - patients who previously received adjuvant biochemotherapy will be eligible,
    unless their treatment included temozolomide or dacarbazine
    7. Any other investigational non-chemotherapeutic therapy for advanced melanoma,
    with the exception of prior monotherapy with interleukin-2, cytokines (eg,
    alfa-interferon or GM-CSF) or vaccine, which are permitted
    - use of anti-CTLA4 monoclonal antibodies will be allowed in adjuvant settings
    8. Any non-systemic therapy (except focal palliative radiotherapy) for advanced
    melanoma within 30 days of starting study treatment
    9. Any unresolved toxicity above CTCAE grade 2 from previous anti-cancer therapy,
    apart from alopecia
    10. Brain metastases or spinal cord compression unless treated and stable off treatment
    (eg, steroids) for at least 3 months
    11. Laboratory values as listed below (from laboratory results at Visit 1):
    - ANC <1.5x109/L (1,500 per mm3)
    - Platelets <100x109/L (100,000 per mm3)
    - Haemoglobin lower or equal to 9.0 g/dL
    - Serum bilirubin >1.5xULN
    - AST or ALT >2.5xULN
    12. LDH higher or equal to 2xULN (from the Visit 1 laboratory result)
    13. Cardiac conditions as follows:
    - Uncontrolled hypertension (BP higher or equal to 150/95 despite optimal therapy)
    - Heart failure NYHA Class II or above
    - Prior or current cardiomyopathy
    - Baseline LVEF lower or equal to 50%
    - Atrial fibrillation with heart rate >100 bpm
    - Unstable ischaemic heart disease (myocardial infarction within 6 months prior
    to starting treatment, or angina requiring use of nitrates more than once weekly)
    14. Major surgery within 4 weeks prior to starting study treatment
    15. Hypersensitivity to AZD6244, or dacarbazine or any excipient of these agents
    16. Patients with a history of another primary malignancy within 5 years prior to
    starting study treatment, except adequately treated basal or squamous cell
    carcinoma of the skin, or carcinoma of the cervix in situ and the disease under study
    17. Any evidence of severe or uncontrolled systemic disease, active infection, active
    bleeding diathesis or renal transplant, including any patient known to have
    hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
    18. Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatorybowel disease), or significant bowel resection that would preclude adequate absorption
    19. Female patients who are breast-feeding or patients of reproductive potential who are not employing an effective method of birth control
    20. Clinical judgement by the investigator that the patient should not participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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 this study is defined as the date when all patients receiving AZD6244 have been followed for a minimum period of 12 months since the start of treatment, or the date of the final analysis of the data, whichever is the later.
    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 months1
    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 months1
    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.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 80
    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 Decision2009-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-20
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