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    EudraCT Number:2013-003545-41
    Sponsor's Protocol Code Number:D1344C00001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003545-41
    A.3Full title of the trial
    A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib (AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with Placebo in Combination with Dacarbazine as First Systemic Therapy in Patients with Metastatic Uveal Melanoma (SUMIT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Selumetinib therapy in patients with Metastatic Uveal Melanoma
    A.4.1Sponsor's protocol code numberD1344C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01974752
    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 SponsorAstraZeneca AB
    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 supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation centre
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryUnited States
    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 nameSelumetinib
    D.3.2Product code AZD6244
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSelumetinib
    D.3.9.1CAS number 943332-08-9
    D.3.9.2Current sponsor codeAZD6244 hydrogen Sulfate
    D.3.9.3Other descriptive nameModified INN: Selumetinib hydrogen sulphate
    D.3.9.4EV Substance CodeSUB36237
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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
    Metastatic uveal melanoma
    E.1.1.1Medical condition in easily understood language
    Eye 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 10025654
    E.1.2Term Malignant melanoma of sites other than skin
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of selumetinib in combination with dacarbazine with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS)
    E.2.2Secondary objectives of the trial
    To assess the efficacy of selumetinib in combination with dacarbazine with placebo in combination dacarbazine by assessment of:
    - Objective Response Rate (ORR)
    - Duration of Response (DoR)
    - Change in tumour size

    To assess overall survival (OS) in patients taking selumetinib in combination with dacarbazine compared with those taking placebo in combination with dacarbazine

    Assessment of AEs graded by common Terminology Criteria for Adverse Events (CTCAE) v4.0

    Assessment of standard 12 lead ECGs

    Assessment of standard vital signs (including blood pressure, pulse)

    Assessment of lab parameters (clinical chemistry)

    Assessment of lab parameters (haematology)

    Assessment of lab parameters (urinalysis)

    Assessment of Echocardiogram/multi gated Acquisition Scan (MUGA)

    Ophthalmological assessment

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Clinical diagnosis of metastatic uveal melanoma
    2.Written consent from female or male patients aged 18 years or older
    3.Histological or cytological confirmation of melanoma who are suitable for treatment with dacarbazine chemotherapy
    4.At least one lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and which is suitable for accurate repeated measurements
    - ECOG Performance Status 0-1
    - Life expectancy >12 weeks
    - Normal organ and marrow function
    5.Patients should be able to swallow selumetinib/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 randomisation in the present study
    3.Patients cannot have previously been treated with a systemic anti-cancer therapy. Patients can have had prior intra-hepatic therapy or non-systemic therapy
    4.Having received any of the following within the specified timeframe:
    -Any prior systemic anti-cancer therapy for the treatment of this current diagnosis
    -An investigational drug within 30 days of starting treatment or within five half-lives of the compound (whichever is the most appropriate is at the discretion of the Investigator), or have not recovered from side effects of an investigational drug
    -Any anti-cancer therapy which has not been cleared from the body by the time of starting study treatment
    -Radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
    -Major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) which would prevent administration of study treatment
    -Any prior investigational therapy comprising inhibitors of RAS, RAF or MEK at any time
    -Previous treatment with dacarbazine.

    5.Any unresolved toxicity >CTCAE grade 2 from previous anti-cancer therapy, excluding alopecia
    6.History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib or dacarbazine
    7.Symptomatic brain metastases or spinal cord compression (patients must be treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study
    8.Cardiac conditions as follows:
    -Uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy)
    -Acute coronary syndrome within 6 months prior to starting treatment
    -Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy,
    -Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV,Prior or current cardiomyopathy
    -Baseline LVEF below the LLN (defined for this protocol as <55% on
    echocardiography or institution’s LLN for MUGA)
    -Severe valvular heart disease
    -Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest
    -QTcF >450 ms or other factors that increase the risk of QTc prolongation

    9.Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
    10.Refractory nausea and vomiting, chronic gastrointestinal diseases (eg, inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
    11.History of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
    12.Ophthalmologic conditions:
    - Current or past history of retinal pigment epithelial detachment (RPED)/central serous retinopathy
    - Current or past history of retinal vein occlusion
    - IOP >21 mmHg or uncontrolled glaucoma (irrespective of IOP)

    13.Female patients who are breast-feeding a child
    and male or female patients of reproductive potential who are not employing an effective method of birth control
    14. Judgement by the Investigator that the patient should not participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    PFS by Blind Indepentdent Central Review (BICR) according to RECIST 1.1

    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS: Radiological scans performed from baseline then every 6 weeks thereafter until disease progression has been confirmed by BICR in accordance with RECIST 1.1,assessed up to 18 months
    E.5.2Secondary end point(s)
    ORR by central review of RECIST data

    DoR by central review of RECIST data

    Change in tumour size by central review of RECIST data

    Efficacy in patients by assesment of OS

    Assessment of the safety and tolerability of selumetinib by collection of AE reports

    Determine safety and tolerability by assessment of 12 lead ECGs

    Determine safety and tolerability by assessment of vital signs

    Determine safety and tolerability by assessment of haematology results

    Determine safety and tolerability by assessment of urinalysis results

    Determine safety and tolerability by assessment of MUGA

    Determine safety and tolerability by assessment by Ophthalmologic assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR: From baseline and at every 6 weeks, up to 18 months

    DoR: From baseline and at every 6 weeks, up to 18 months

    Change in tumour size: From baseline and at every 6 weeks, up to 18 months

    OS: Post-progression patients assessed for survival every 8 weeks, up to 30 months

    AEs: From baseline and at each study visit up to 30 months

    ECGs: From baseline, up to 30 months

    Vital signs: From baseline and at each study visit up to 30 months

    Haematology: From baseline and at each study visit up to 30 months

    Urinalysis: From baseline and at each study visit up to 30 months

    MUGA: From baseline and every 12 weeks up to 30 months

    Ophthalmologic: From baseline, up to 30 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 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 Yes
    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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Czech Republic
    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
    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 months0
    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 months0
    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: 113
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 128
    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)
    Following confirmation of objective disease progression by BICR, patients will be unblinded to identify whether they were receiving selumetinib or placebo. All patients, regardless of initial treatment, will have three options for post-progression therapy to consider:
    1.Receive alternative treatment approach at the investigative site
    2.Receive open-label selumetinib monotherapy
    3.Receive open-label selumetinib in combination with dacarbazine

    See sections 3.1.6, 5.8 and 5.9 of the 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 Decision2014-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
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