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    Summary
    EudraCT Number:2006-006538-16
    Sponsor's Protocol Code Number:A6181114
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-06
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2006-006538-16
    A.3Full title of the trial
    AN OPEN-LABEL SUNITINIB MALATE (SU011248) CONTINUATION PROTOCOL FOR PATIENTS WHO HAVE COMPLETED A PRIOR SUNITINIB STUDY AND ARE JUDGED BY THE INVESTIGATOR TO HAVE THE POTENTIAL TO BENEFIT FROM SUNITINIB TREATMENT
    A.4.1Sponsor's protocol code numberA6181114
    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
    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
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/267; EU/3/05/268
    D.3 Description of the IMP
    D.3.1Product nameSutent
    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 typerange
    D.3.10.3Concentration number12,5/25 to 50
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Malignant gastrointestinal stromal tumor (GIST), Metastatic Breast Cancer, Metastatic Renal Cell Cancer or Pancreatic Islet Cell Tumor.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level HLGT
    E.1.2Classification code 10027655
    E.1.2Term Miscellaneous and site unspecified neoplasms malignant and unspecified
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To provide access to sunitinib treatment for subjects who have participated in previous “parent” sunitinib protocols and who have the potential as judged by the investigator to derive clinical benefit from sunitinib treatment.

    •To assess the long-term safety and tolerability of sunitinib given in a continuous daily dose schedule (or of the combination of sunitinib and exemestane for subjects from parent protocol A6181108).

    •To assess the duration of clinical benefit for subjects taking sunitinib (or the combination of sunitinib and exemestane for subjects from parent protocol A6181108).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must have participated in a previous Pfizer Worldwide medical sponsored parent sunitinib study (as specified below) and, in the opinion of the parent study investigator are thought to have the potential to derive clinical benefit from continued treatment with sunitinib.
    • Protocol A6181107 subjects randomized to sunitinib who have completed treatment on the trial and who have shown clinical benefit.
    •Protocol A6181107 subjects randomized to capecitabine whose disease progressed on capecitabine during the study.
    •Protocol A6181108 subjects who have completed 2 years of treatment with sunitinib/exemestane and have shown clinical benefit.
    •Protocol A6181110 subjects who have completed one year of sunitinib treatment and have shown clinical benefit.
    •Protocol A6181111 subjects randomized to placebo whose disease has progressed while on placebo during the study.
    •Protocol A6181111 subjects who were randomized to either sunitinib or placebo, have completed the entire study treatment period, and have shown clinical benefit (sunitinib treated patients) or have stable disease (placebo patients) at the end of the trial.
    •Protocol A6181112 subjects randomized to sunitinib, who have completed the study and who have shown clinical benefit.
    2. ECOG performance status 0, 1 or 2
    3. Able to swallow an oral compound
    4. Adequate organ function as defined by the following criteria at their last study visit on the previous parent protocol, or at the first visit for this study. 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). If liver function abnormalities are due to underlying malignancy, then AST and ALT may be £5 x ULN.
    •Total serum bilirubin £1.5 x ULN
    •Prothrombin time (PT) and partial thromboplastin time (PTT) £1.5 x ULN
    •Serum albumin >3.0 g/dL
    •Absolute neutrophil count (ANC) >1500/mL
    •Platelets >100,000/mL
    •Hemoglobin >9.0 g/dL
    •Serum creatinine <1.5 x ULN
    •Serum amylase and lipase <1.0 x ULN
    5. Subjects must enroll as soon as possible from their End of Treatment/Withdrawal visit in the previous parent study, but in all cases within 4 weeks of this visit.
    6. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
    7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
    8. Male or female, 18 years of age or older.
    E.4Principal exclusion criteria
    1.Current treatment in another clinical research trial.
    2.Concurrent treatment with another anti-cancer drug except with exemestane as specified in this protocol.
    3.Evidence of neurological signs/symptoms secondary to brain metastases, spinal cord compression, or new evidence of brain or leptomeningeal disease.
    4.Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
    5.Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
    6.Treatment with potent CYP3A4 inhibitors and inducers within 7 and 12 days, respectively, prior to study drug administration. Potent CYP3A4 inhibitors and inducers will not be allowed as concomitant medications during the study.
    7.Current treatment with therapeutic doses of anticoagulant (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
    8.Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
    9.Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
    10.Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illness.
    11.Pregnancy or breastfeeding. Subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
    12.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 the study.
    E.5 End points
    E.5.1Primary end point(s)
    The objective of the study is to provide access to sunitinib treatment and assess long term safety, tolerability, and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint. The following will be collected and reported on:
    •Duration of clinical benefit: For subjects who were taking sunitinib in the parent protocol, duration of clinical benefit is defined as the length of time subjects remain on sunitinib from the first day of treatment on the parent protocol (or the combination of sunitinib and exemestane for subjects in parent protocol A6181108) until the end of sunitinib treatment in this study. For subjects who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time subjects are on sunitinib in this study.
    •Type, incidence, severity, timing, seriousness, and relatedness of Adverse Events
    In addition, for the purpose of calculating Overall Survival (OS) for the parent protocols, with the exception of A6181110, for which OS is not calculated, survival information will be collected and added to the Case Report Form (CRF) both during the term of this study, as well as after the subject terminates treatment in this study.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    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
    Subjects should continue to be evaluated for 28 calendar days after the last dose of study drug. During the post-treatment follow-up visit, the following procedures should be performed:

    •Assessment of adverse events
    •Assessment of concomitant medications and treatments
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 394
    F.4.2.2In the whole clinical trial 1400
    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)
    End of Trial in a Member State of the European Union 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 by a Member State is not a reason for premature termination but is considered a normal conclusion to the trial in that Member State
    End of Trial in all participating countries is defined as last subject, last visit.
    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 Decision2007-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-08-12
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