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    Summary
    EudraCT Number:2006-003772-35
    Sponsor's Protocol Code Number:AURA-6202-006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-13
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-003772-35
    A.3Full title of the trial
    Phase II study of PHA-739358 administered by a 24-hour IV infusion every 14 days in advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung and non small cell lung cancers.
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberAURA-6202-006
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot available
    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 SponsorNerviano Medical Sciences S.r.l.
    B.1.3.4CountryItaly
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namenot applicable
    D.3.2Product code PHA-739358
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDanusertib
    D.3.9.1CAS number 827318-97-8
    D.3.9.2Current sponsor codePHA-739358
    D.3.9.3Other descriptive nameAurora kinase inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung, non small cell lung and squamous non small cell lung cancers.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033610
    E.1.2Term Pancreatic carcinoma metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059514
    E.1.2Term Small cell lung cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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 determine if PHA-739358 has an antitumor activity against breast, ovarian, pancreatic, colorectal, small and non-small cell lung cancers.
    E.2.2Secondary objectives of the trial
    ·To evaluate the antitumor activity of PHA-739358 in comparison to the last prior therapy,
    ·To evaluate the safety profile of PHA-739358,
    ·To monitor the PK of PHA-739358 in plasma,
    ·To analyze genes/proteins which might predict responsiveness to Aurora kinase inhibitors in tumor biopsies collected at diagnosis and/or thereafter from ovarian cancer patients,
    .To analyze genes/proteins which might predict responsiveness to PHA-739358 in parafin embedded tumor biopsies collected at diagnosis and/or thereafter, in any case before the enrollment in the study, from NSCLC patients with squamous cell histology.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically or cytologically documented progressive advanced/metastatic disease in one of the following solid tumors (see below):
    · Breast cancer (3rd line of chemotherapy),
    · Ovarian cancer (3rd line, platinum resistant/refractory disease),
    · Colorectal cancer (3rd line),
    · Pancreatic Cancer (2nd line),
    · Small Cell Lung Cancer (2nd line),
    · Non Small Cell Lung Cancer (2nd line),
    . Squamous Non Small Cell Lung Cancer (2nd line).

    Note: Any adjuvant chemotherapy followed by the recurrence of the disease within 12 months after the start of the adjuvant treatment will be considered as one chemotherapy line for advanced/metastatic disease.
    Platinum Resistant: Disease that relapsed within 6 months after completing prior platinum therapy.
    Platinum Refractory: Disease that progressed or was stable during prior platinum therapy.

    2. Prior chemotherapy must have been completed 2 weeks before study entry.

    3. Available information on the first day of administration of the previous chemotherapy and the precise date when progression has been assessed.

    4. Prior radiotherapy is allowed provided that a minimum of 2 weeks has elapsed between the end of prior radiotherapy and the entry into the trial.

    5. Age 18 years or older.

    6. ECOG performance status 0 – 1.

    7. Life expectancy of at least 3 months.

    8. Hematological and biochemical parameters:
    · Bilirubin ≤1,5 UNL,
    · AST/ALT ≤ 2,5 UNL (≤ 5 UNL in case of liver metastases),
    · ALP ≤ 2,5 UNL (≤ 5 UNL in case of liver and/or bone metastases),
    · Creatinine within normal limits (if out of range then perform the Creatinine clearance evaluation ≥ 50 ml/min),
    · ANC ≥ 1,500 cells/mm3,
    · Platelets count ≥ 75,000 cells/mm3,
    · Hemoglobin ≥ 10 g/dl.

    9. All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTCAE version 3.0 grade ≤ 1.

    10. Personally signed and dated IEC/IRB-approved informed consent form.

    11. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    1. Previous high-dose chemotherapy requiring bone marrow rescue.

    2. Concurrent enrollment in another investigational drug trial within the last 4 weeks.

    3. Known brain or leptomeningeal disease (baseline computerized tomography [CT] or MRI scan of the brain required only in case of clinical suspicion of central nervous system metastases).

    4. Uncontrolled hypertension with blood pressure exceeding 160/100 mmHg.

    5. Pregnancy or breast-feeding. Female patients must agree to avoid becoming pregnant during the study and in the following 3 months after the end of the treatment, be surgically sterile or be postmenopausal. Male patients must agree to have no intention to father a child during the study and in the following 3 months after the end of the treatment.

    6. Abnormal LVEF < 40% by Echocardiography or MUGA <45%.

    7. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event.

    8. Cardiac dysrhythmias grade ≥ 2 according to NCI CTCAE version 3.0.

    9. Known active infection including known human immunodeficiency virus (HIV) positivity.

    10. 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.

    11. History of previous cancer, except skin basal-cell carcinoma or in situ carcinoma of the cervix, within the previous 5 years.

    12. Marked baseline prolongation of QT/QTc interval [e.g., repeated demonstration of a QTc interval > 450 milliseconds (ms)].

    13. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).

    14. Use of concomitant medications that prolong the QT/QTc interval.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Rate at 4 months of treatment.
    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 Yes
    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 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 EEA22
    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
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 212
    F.4.2.2In the whole clinical trial 224
    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)
    Medical care for those conditions.
    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 Decision2007-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-25
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