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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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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    EudraCT Number:2011-001098-16
    Sponsor's Protocol Code Number:MO10/9353
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-05-05
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-001098-16
    A.3Full title of the trial
    STAR: A Randomised Multi-Stage Phase II/III trial of Sunitinib comparing Temporary cessation with Allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced and/or metastatic Renal cancer
    A.3.2Name or abbreviated title of the trial where available
    STAR-Standard vs Modified Sunitinib Treatment in Renal Cancer V1.0
    A.4.1Sponsor's protocol code numberMO10/9353
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN06473203
    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 SponsorUniversity of Leeds
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    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 Information not present in EudraCT
    D. name Sunitinib (trade name Sutent)
    D. of the Marketing Authorisation holderPfizer Ltd
    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 nameSunitinib
    D.3.2Product code n/a
    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.3.11 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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic and/or locally advanced Renal Clear Cell Carcinoma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the STAR trial is to evaluate the use of a Modified sunitinib schedule compared to the Standard sunitinib schedule, in patients with locally advanced and/or metastatic renal cancer. The trial has three stages and should the trial not meet predetermined endpoints in its initial 2 stages (A and B), then recruitment will not continue to the third stage (stage C).

    Stage A:
    To establish the feasibility of performing the trial in terms of recruitment and whether the final required sample size is likely to be achieved and in a timely manner. Average monthly recruitment between months 10-21 inclusive will be used to determine this.

    Stage B:
    To provide an initial indication that the Modified sunitinib schedule (with planned treatment breaks) is not significantly worse than the Standard sunitinib schedule, by comparing the time until participants permanently stop sunitinib in each treatment arm.

    Stages A B and C:
    To show that the Modified sunitinib schedule is not wors
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate how the Modified Schedule compared to the Standard Schedule impacts on:
    • Summative Progression Free Interval (SPFI, adding together the time periods that the cancer is controlled for)
    • Time to Strategy Failure (TSF, time until sunitinib is stopped permanently)
    • Side Effects/toxicity (using CTCAE v.4.0)
    • Quality of Life (QoL) questionnaires (Questionnaires to be used are FSKI, FACT-G, EQ-5D and EQ-VAS)
    • Cost-effectiveness
    • Progression free survival (PFS, how long participants live without their cancer progressing)

    Translational sub-studies are also planned with the main aim of developing biomarkers to give an early prediction of response to sunitinib (please see more details in Section A13.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    -Functional Imaging Sub-Study: Dynamic Contrast Enhanced-MRI (DCE-MRI) Evaluation 01/04/2011 v1.0
    -Computerised Tomography Imaging Sub-study 01/04/2011 v1.0
    - Tissue studies 01/04/2011 v1.0

    E.3Principal inclusion criteria
    1. Male or female aged ≥ 18 years old
    2. Histological confirmation of predominantly clear cell renal cell cancer
    3. Inoperable loco-regional and/or metastatic disease
    4. No prior systemic therapy for advanced disease (inoperable loco-regional and/or metastatic disease)
    5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    6. Uni-dimensionally measurable disease (RECIST criteria)
    7. Full blood count:
    • Haemoglobin (Hb) ≥ 9 g/dl
    • Absolute Neutrophil Count (ANC) ≥ 1 x 109/l
    • Platelets ≥ 80 x 109/l
    8. Renal biochemistry:
    • Measured or calculated GFR ≥ 30 ml/min
    9. Hepatobiliary function
    • Aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 2.5 x ULN
    • Bilirubin (BR) ≤ 1.5 x ULN, or ≤ x3 x ULN and direct BR ≤ 35% in patients with Gilbert’s syndrome
    10. Able to provide written informed consent prior to any trial-specific procedures
    11. Able and willing to comply with the terms of the protocol including:
    • commencement of sunitinib within 3 days of randomisation
    • temporarily stopping sunitinib if randomised to the DFIS arm
    • capable of oral self-medication
    • capable of reporting toxicity and completing quality of life (QoL) and medical resource utilisation (MRU) questionnaires
    12. If female and of child-bearing potential, must:
    • have a negative pregnancy test within 72 hours prior to randomisation, and not be breast-feeding
    • agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during, and for 6 months after the last dose of sunitinib
    13. If male with a partner of child bearing potential, must
    • agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during, and for 6 months after the last dose of sunitinib

    Allowed situations include:
    • primary renal cancer in-situ or previous nephrectomy,
    • previous brain metastases treated with complete surgical resection or gamma knife with no subsequent evidence of progression (patients treated with whole brain radiotherapy are not eligible)
    • previous treatment in the SORCE study providing on placebo arm and NOT active sorafenib arms (The SORCE trial is investigating whether treatment of renal cancer with sorafenib (also a tyrosine kinase inhibitor [TKI]) in the adjuvant setting is effective in reducing development of metastases in high risk patients compared with placebo. By agreement with the Chief Investigator of the SORCE trial, patients who have previously participated in SORCE and have progressed and are no longer on the SORCE trial, will be eligible for STAR, subject to confirmation (through unblinding) that that they received placebo and not active drug (sorafenib) on the SORCE study.
    • previous radiotherapy and/or previous/ongoing bisphosphonates or bone- resorptive drugs (e.g. denosumab) for the treatment of symptomatic bony metastasis.
    E.4Principal exclusion criteria
    1. Pulmonary or mediastinal disease causing obstruction or bleeding/haemoptysis
    2. Patients with an estimated life expectancy of < 6 months
    3. Known contraindications to sunitinib
    4. No previous treatment with sunitinib or other tyrosine kinase inhibitor (including in the adjuvant setting)
    5. Untreated brain metastases
    6. Any concurrent or previous other invasive cancer that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer acceptable, for all other cases please discuss with CTRU)
    7. Hypersensitivity to sunitinib
    8. Any concomitant medication or substances forming part of local ongoing care known to significantly affect, or have the potential to significantly affect, the activity or pharmacokinetics of sunitinib (see section 10.2 for further information on concomitant medications)
    9. Poorly controlled hypertension despite maximal medical therapy
    10. Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the STAR trial, including gastro-intestinal abnormalities limiting effectiveness of orally administrated drugs, uncontrolled infections, current or recent history of clinically significant cardiovascular disease which, in the opinion of the local investigator, would render the patient unsuitable for standard sunitinib therapy
    E.5 End points
    E.5.1Primary end point(s)
    The study has two co-primary endpoints:
    • 2 year Overall Survival
    • Quality Adjusted Life Years averaged over trial recruitment and follow up
    This trial of sunitinib in renal cancer will determine whether, by utilising the Modified Schedule of sunitinib (DFIS), survival benefits can be maintained, whilst other important outcomes, such as QoL and cost effectiveness, can be improved, compared to utilising the Standard Schedule of sunitinib (CCS). Oncological treatments for patients with incurable disease require assessment using standard measures of efficacy, such as survival. It is however recognized that other measures must also be taken into consideration including QoL and cost, particularly in the context of the economic constraints of the NHS. When seeking approval from NICE for a new treatment, all of these outcomes are considered. A composite co-primary endpoint (quality adjusted life years averaged over trial recruitment and follow up) is utilised to more accurately assess whether and how any detriment in survival might be balanced with improvements in quality of life and cost-effectiveness.

    Stage-Specific Primary Endpoints

    Stage A
    Recruitment rate between months 10-21 of the trial (defined as the average recruitment rate per centre open per month between month 10 and 21 of the trial inclusive).

    Stage B
    Time to Strategy Failure, defined as time from randomisation until:
    a) death;
    b) disease progression on sunitinib in the CCS arm;
    c) disease progression assuming no further disease response or stabilisation on subsequent sunitinib occurs, in DFIS arm, or
    d) patient requires use of a new systemic anti-cancer agent for RCC (end point measured at the first of either time of disease progression or time of initiation of new agent), or
    e) disease progression during a planned treatment break and receiving no further sunitinib within 4 weeks.

    Stages A B and C
    • 2 year Overall Survival (defined as the time from randomisation to the trial to death from any cause or last follow-up. Analyses are targeted to look at differences in 2 year survival, but all follow-up will be incorporated).

    • Quality Adjusted Life Years averaged over trial recruitment and follow up

    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Comparator is conventional continuation strategy using same IMP (cf. to drug-free interval strategy)
    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 concerned38
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The end of the trial is defined as the date all 2 year follow-up assessments are completed for all trial participants evaluable at this timepoint.

    Any participants still responding to their protocol-defined treatment strategy after their 2 year follow-up assessment will continue to receive sunitinib treatment as per protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 1000
    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)
    All trial participants will be treated either with a standard sunitinb schedule(CCS) or a modified sunitinib schedule (DFIS) until the drug is no longer controlling their disease (either disease progression whilst taking sunitinib, unacceptable toxicity or participant choice to withdraw from the trial).

    The Participant Information Sheet explains that sunitinib is the standard treatment for this patient population. If a participant was to withdraw their consent from the trial but they were s
    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 Decision2011-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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