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    Summary
    EudraCT Number:2005-000525-30
    Sponsor's Protocol Code Number:A6181055
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-07-11
    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 ConcernedGreece - EOF
    A.2EudraCT number2005-000525-30
    A.3Full title of the trial
    AN OPEN LABEL INTERNATIONAL MULTI-CENTER PHASE 2 ACTIVITY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA
    A.4.1Sponsor's protocol code numberA6181055
    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 Hellas A.E.
    B.1.3.4CountryGreece
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/267
    D.3 Description of the IMP
    D.3.2Product code SU011248 L-Malate Salt
    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.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12,5- 25 - 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 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Histologically confirmed diagnosis of hepatocellular carcinoma. Patients with the fibrolamellar histology or a mixed histology are not eligible.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level VTc
    E.1.2Classification code 10019697
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the antitumor activity of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks repeated every 6 weeks in patients with unresectable hepatocellular carcinoma.
    E.2.2Secondary objectives of the trial
    - To assess measures of clinical benefit and duration of tumor control
    - To evaluate the safety and tolerability of SU011248
    - To evaluate SU011248 and SU012662 trough concentrations (Ctrough) and to
    correlate these plasma concentrations with activity and safety parameters
    - To explore the correlations of cancer biomarkers with cancer- and treatment-
    related outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of hepatocellular carcinoma. Patients with the
    fibrolamellar histology or a mixed histology are not eligible.
    2. Patients must present with disease not amenable to curative surgery (i.e. either
    hepatectomy, or liver transplant).
    3. Patients previously undergoing local treatment, such as surgery, radiation
    therapy, hepatic arterial embolization, chemoembolization, radiofrequency
    ablation, percutaneaous ethanol injection, or cryoablation are eligible if they
    have subsequently progressed or recurred. A minimum delay of 4 weeks is
    required between local therapy and progression.
    4. Resolution of all acute toxic effects of any prior local treatment to National
    Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE
    version 3.0) grade less than/ equal to 1.
    5. Measurable disease according to RECIST.
    6. No cirrhosis or cirrhotic status up to Child-Pugh class B.
    7. 18 years of age or older.
    8. ECOG performance status 0 or 1.
    9. Required baseline laboratory data within the following parameters:
    - Neutrophils ≥1,500/mL
    - Platelets ≥60,000/mL
    - Hemoglobin ≥8.5 g/dL
    - Serum albumin≥2.8 g/dL
    - Serum bilirubin less than/equal to 3 mg/dL
    - Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase
    [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate
    transferase [SGPT]) less than /equal to 5 x ULN
    - INR less thna /equal to 1.7 or Prothrombin time (PT) less than/equal to 6 sec
    over ULN
    - Serum creatinine < 1.5 x ULN.
    10. Life-expectancy of ≥ 3 months.
    11. Signed and dated an informed consent indicating that the patient (or legally
    acceptable representative) has been informed of all the 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. Prior treatment with any systemic treatment for HCC.
    2. Prior treatment on a SU011248 clinical trial.
    3. Prior local therapy (such as surgery, radiation therapy, hepatic arterial
    embolization, chemoembolization, radiofrequency ablation, percutaneous
    ethanol injection or cryoablation) of target lesions at any prior time, unless
    progressed or recurred as per RECIST or WHO.
    4. Prior history of liver transplant.
    5. Presence of clinically relevant ascites (i.e. requiring paracentesis).
    6. NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment.
    7. Diagnosis of any second malignancy within the last 3 years, except basal cell
    carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that
    has been adequately treated with no evidence of recurrent disease for 12
    months.
    8. History of or known brain metastases, spinal cord compression, or carcinomatous
    meningitis, or new evidence of brain or leptomeningeal disease.
    9. Any of the following within the 12 months prior to study drug administration:
    severe/unstable angina, myocardial infarction, coronary artery bypass graft,
    symptomatic congestive heart failure, cerebrovascular accident, including
    transient ischemic attack, or pulmonary embolism.
    10. 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.
    11. Hypertension that cannot be controlled by medications (blood pressure >150/90
    mmHg despite optimal medical therapy).
    12. Treatment with anticonvulsant agents and treatment with therapeutic doses of
    warfarin currently or within 2 weeks prior to first day of SU011248
    administration. Low dose warfarin for DVT prophylaxis is permitted (up to 2
    mg/day). Low molecular weight heparin is allowed.
    13. Inability to swallow oral medications, or presence of active inflammatory bowel
    disease, partial or complete bowel obstruction or chronic diarrhea.
    14. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
    syndrome (AIDS)-related illness.
    15. Pregnancy or breastfeeding. All female patients with reproductive potential
    must have a negative pregnancy test (serum or urine) within the 7 days prior to
    enrollment.
    16. 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.
    17. Receipt of any investigational agent prior to study entry.
    18. Current treatment on another therapeutic clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) as determined according to RECIST
    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 Information not present in EudraCT
    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) 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 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) No
    E.8.2.2Placebo No
    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.8.5The 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 Information not present in EudraCT
    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
    All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or withdrawal of patient consent. After discontinuation of treatment and the mandated 28-day follow up, patients will be followed only in order to collect information on further antineoplastic therapy and survival.
    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 years1
    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 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 160
    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 Decision2006-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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