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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2006-004451-38
    Sponsor's Protocol Code Number:A6181092
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-004451-38
    A.3Full title of the trial
    A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND BRAIN METASTASES
    A.4.1Sponsor's protocol code numberA6181092
    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 Inc. - 235 East 42nd Street - New York - 10017
    B.1.3.4CountryUnited States
    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.3.2Product code SU011248
    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 typeequal
    D.3.10.3Concentration number12,5mg 25 mg to 50 mg
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of SU011248 in patients with NSCLC and brain metastases,
    previously treated with Whole Brain Radiation Therapy (WBRT) and up to 1 prior systemic therapy
    E.2.2Secondary objectives of the trial
    • To evaluate the intracranial antitumor activity of SU011248 in patients with NSCLC and brain metastases, previously treated with WBRT and up to 1 prior systemic therapy and having measurable brain disease
    • To evaluate the safety and tolerability of SU011248 administered in a continuous dose treatment regimen
    • To explore patient reported outcomes (PRO)
    • To evaluate SU011248 and SU012662 trough concentrations (Ctrough) and to correlate these plasma concentrations with efficacy and safety parameters
    • To explore the relationships of cancer biomarkers with clinical outcomes
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title:
    CLINICAL PHARMACOGENOMICS SUPPLEMENT - A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND BRAIN METASTASES

    Version and Date: Final - 23 June 2006

    Objectives:
    The primary objective of this additional research component is to allow for the collection, storage, and use of samples to investigate possible associations between genomic (eg DNA, RNA, protein) variation in relation to response to SU011248 (sunitinib) and in relation to characteristics of Non-Small Cell Lung Cancer (NSCLC) and related conditions. Scientific information about these differences among groups of subjects can help researchers to better understand the response of subjects to investigational drugs such as SU011248 and to learn more about conditions such as NSCLC.

    The secondary objective is to collect, store, and use the samples as controls in genomic investigations of the causes, natural history, and other aspects of important diseases and conditions for which Pfizer is researching new or improved drug therapies.
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed NSCLC
    2. Radiologically proven brain metastases secondary to histologically or cytologically
    confirmed NSCLC. Prior resection of brain metastases is allowed provided at least 1
    metastatic brain lesion can be followed by postoperative MRI.
    3. Previous whole brain radiation therapy ≥2 weeks prior to study entry.
    4. None or 1 prior systemic therapy for the treatment of advanced/metastatic NSCLC.
    5. Patients who received prior systemic therapy for the treatment of NSCLC must have
    evidence of disease progression.
    6. Completion of all prior chemotherapy, immunotherapy, and radiotherapy ≥4 weeks prior to study entry, and resolution of all acute toxic effects of any prior systemic anticancer therapy, radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ≤1. Note: WBRT may have occurred ≥2 weeks prior to study entry.
    7. For systemic disease, evidence of unidimensionally measurable disease. Measurable brain disease is not required.
    8. Male or female, 18 years of age or older.
    9. ECOG performance status 0 or 1.
    10. Adequate organ function as defined by the following criteria:
    • Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase
    [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate
    transferase) [SGPT] ≤2.5 x upper limit of normal (ULN)
    • Total serum bilirubin ≤1.5 mg/dL
    • Prothrombin time (PT) ≤1.5 x ULN
    • Absolute neutrophil count (ANC) ≥1500/mL
    • Platelets ≥100,000/mL
    • Hemoglobin ≥9.0 g/dL
    • Serum creatinine ≤1.5 x ULN
    • Sodium ≥120 mEq/L
    • 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 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. Brainstem lesions, spinal cord compression, carcinomatous meningitis, or
    leptomenengeal disease
    2. Brain metastases >4 cm in any linear direction
    3. Candidate for definitive therapy for brain metastases (e.g. Gamma Knife, surgery).
    4. Evidence of tonsillar or tentorial herniation
    5. Intracranial or intratumoral hemorrhage (except those with punctuate asymptomatic intratumoral bleeds).
    6. Uncontrolled seizure activity
    7. Treatment with potent CYP3A4 enzyme inducers or inhibitors within the past 2 weeks.
    Note 1: Patients on steroids must be dose reduced to the lowest possible dose if steroids cannot be completely discontinued.
    Note 2: Steroid dose must be stable (or decreasing) for at least 2 weeks at the time of study entry.
    Note 3: Patients taking anticonvulsants that affect CYP3A4 enzyme activity (e.g.
    phenytoin, carbamazepine) must switch to an anticonvulsant that is not a potent enzyme inducer, e.g. Keppra(levetiracetam).
    8. Ongoing treatment with therapeutic doses of Coumadin.
    9. Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior
    palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
    Note 1: WBRT must have occurred ≥ 2 weeks prior to study entry.
    Note 2: Resection of brain metastases is allowed provided at least 1 metastatic lesion is available for follow-up.
    10. NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment.
    11. Evidence of hemoptysis <4 weeks of starting study treatment. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to <5 mL of blood per episode and <10 mL of blood per 24-hour period in the best estimate of the investigator.
    12. Uncontrolled hypertension defined as blood pressure >150/100 mm Hg that cannot be controlled with standard antihypertensive agents.
    13. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
    14. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolism.
    15. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
    16. Known human immunodeficiency virus (HIV) infection.
    17. Current treatment on another therapeutic clinical trial.
    18. Pregnancy or breastfeeding. Female patients must be surgically sterile or be
    postmenopausal, or must agree to use effective contraception during the period of
    therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study treatment.
    19. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
    20. Receipt of any investigational agent within 4 weeks prior to study entry.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is Progression Free Survival (PFS.)
    PFS is defined as the difference in days between the first date that criteria for progression were met or the patient died due to any cause, and the date of first dose of medication. Since the day of first dose of medication and the day criteria for progression were met (or the day patient died due to any cause) are each counted as a full day, 1 day will be added to each calculation. Patients lacking a post-baseline evaluation of tumor response will have their event times censored at 1 day. PFS data will be censored on the day following the date of the last on treatment (including the 28 day follow-up period) tumor assessment documenting absence of progressive disease for patients who:
    • Do not have objective tumor progression and who do not die due to any cause while on treatment;
    • Are given anti-tumor treatment other than the study treatment, prior to observing objective tumor progression.
    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 Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    End of Trial in a Member State is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application and ethics application in the Member State. Poor recruitment is considered a normal conclusion to the trial in that Member State.

    End of Trial in all participating countries is defined as the time at which all patients enrolled in the study have completed treatment on study.
    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 years2
    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.1.3Elderly (>=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 30
    F.4.2.2In the whole clinical trial 60
    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)
    Upon study discontinuation patients will be followed every 2 months until death. Patients receiving clinical benefit, in the investigator’s opinion, from treatment will be offered continued access to SU011248 through participation on a separate protocol at the discretion of the investigator.
    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 Decision2008-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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