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    Summary
    EudraCT Number:2008-002309-38
    Sponsor's Protocol Code Number:CASA404A2302
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-002309-38
    A.3Full title of the trial
    A phase III, randomized, double-blind, placebo-controlled multi-center study of ASA404 in combination with docetaxel in second-line treatment of patients with locally advanced or metastatic (stage IIIb/IV) non-small cell lung cancer (NSCLC).
    A.3.2Name or abbreviated title of the trial where available
    ATTRACT-2
    A.4.1Sponsor's protocol code numberCASA404A2302
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.3.2Product code ASA404
    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.3.9.1CAS number 29095-08-5
    D.3.9.2Current sponsor codeASA404
    D.3.9.3Other descriptive name5,6-Dimethylxanthenone-4-acetic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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.IMP: 2
    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 nameDocetaxel
    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.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with stage IIIb/IV NSCLC of all histologies, who have progressed while on or following a first-line therapy treatment (including bevzcizumab and/or EGFR inhibitors) and are eligible for second-line line chemotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non small cell lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare overall survival between the ASA404 plus docetaxel group and the placebo plus docetaxel group
    E.2.2Secondary objectives of the trial
    • To compare Progression-Free Survival (PFS) and the Overall Response Rate (ORR) per RECIST assessed by the investigators between patients receiving ASA404 or placebo in combination with docetaxel.
    • To assess Time to Response (CR or PR) and Duration of Response per RECIST assessed by the investigator between patients receiving ASA404 or placebo in combination with docetaxel.
    • To assess safety of ASA404 in combination with docetaxel.
    • To determine population pharmacokinetics and factors influencing systemic exposure to ASA404.
    • To assess physical functioning and global health status quality of life (QoL) as measured by the EORTC QLQ-C30 in patients receiving ASA404 or placebo in
    combination with docetaxel.
    • To assess lung cancer specific symptoms as measured by the QLQ-LC13 in patients
    receiving ASA404 or placebo in combination with docetaxel
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploartory Biomarker study for CASA404A2302, dated 22 July 2008.

    Exploratory pharmacogenetic assessments are planned as part of this study with the objectives of examining whether individual genetic variation in genes relating to drug metabolism, NSCLC and the drug target pathway confer differential response to ASA404.

    See Protocol Post Text Supplement 3 for full details
    E.3Principal inclusion criteria
    1. Histologically confirmed non-small cell carcinoma of the lung of all histologies.
    2. Patients who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible
    3. Age ≥ 18 years old
    4. WHO Performance Status of 0-2
    6. Central laboratory values within the range, as defined below, within 2 weeks of randomization:
    • Absolute neutrophils count (ANC) ≥ 2.0 x 109/L
    • Platelets ≥ 100 x109/L
    • Hemoglobin ≥ 10 g/dL
    • Serum creatinine ≤ 1.5 x ULN
    • Serum bilirubin ≤ 1.5 x ULN
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)
    • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x ULN
    • Electrolyte values (sodium, potassium, calcium, magnesium) within ≥1 x LLN and ≤ 1 x ULN. Patients with corrected electrolyte values are eligible
    • Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing). Any female presenting with a positive or borderline pregnancy test may undergo a gynecological exam and ultrasound to rule out pregnancy and if found to be negative
    may be included in the trial.
    7. Life expectancy ≥ 12 weeks
    8. Written informed consent obtained according to local guidelines
    E.4Principal exclusion criteria
    1. Patients having CNS metastases
    2. Patients with concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer.
    3. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all acute radiotherapy-related toxicities.
    4. Major surgery must be completed 4 weeks prior to starting study treatment. Major surgery is defined at the investigator’s discretion. Insertion of a vascular access device is not considered major or minor surgery. Patients must have recovered from all acute major surgery-related complications.
    5. Treatment with all prior anticancer therapies≤ 3 weeks prior to randomization (≤ 6 weeks for bevacizumab, mitomycin and nitrosoureas)
    6. Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
    7. Prior treatment with docetaxel in the locally advanced or metastatic first-line setting
    8. Prior treatment with VDAs or tumor - VDAs
    9. Any medical condition resulting in ≥ CTC grade 2 dyspnea
    10. Patients with systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg while on medication for hypertension
    11. Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
    12. Patients with any one of the following:
    • Patients with long QT syndrome
    • Patients with a Baseline 12-lead ECG QTcF of > 450 msec for women using the Fridericia [QTcF formula] measurement determined per central ECG evaluation report
    • Congestive heart failure (NY Heart Association class III or IV)

    • Patients with a myocardial infarction within 12 months of starting study treatment or with implanted cardiac pacemaker
    • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
    • History of poorly-controlled labile hypertension or poor compliance with antihypertensive regimen
    • History of a sustained ventricular tachycardia
    • Presence of atrial tachyarrhythmia (e.g. atrial fibrillation, atrial flutter, multifocal atrial tachycarida, supraventricular tachycardia) in not effectively rate-controlled
    • Any history of ventricular fibrillation or Torsades de Pointes (TdP)
    • Right bundle branch block (RBBB) and either left anterior hemiblock or left posterior hemiblock (bifasicular block)
    • Bradycardia defined as heart rate < 50 beats per minute

    13. Patients who are currently receiving treatment with any medications that have the potential to prolong QT interval or are known to have Concomitant use of drugs with a risk of causing Torsades de Pointes (See Section 6.8.5.1Table 6-4 and Appendix 2) which cannot be either safely discontinued or switched to a different medication prior to starting study drug administration must be discussed with and approved by the Novartis Global Clinical team prior to randomization
    14. Known allergy or hypersensitivity to docetaxel or drugs formulated with polysorbate 80
    15. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
    16. Pregnant or breast feeding females
    17. Women of child bearing potential or sexually active males,
    unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment.
    18. Concurrent severe and/or uncontrolled medical disease
    19. Significant neurologic or psychiatric disorder which could compromise participation in the study
    20. Patient unwilling or unable to comply with the protocol
    21. Patients receiveing full-dose therapeutic oral or parenteral antiguagulation are ineligible. Patients receiving thrombolytic therapy within 10 days starting study treatment are also ineligible.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be overall survival
    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 Yes
    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.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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA210
    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 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 final analysis wil be perfored with 693 events are observed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    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 months3
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 365
    F.4.2.2In the whole clinical trial 900
    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)
    Optional maintenance treatment until documented disease progression, unacceptable toxicity or consent withdrawn. Tumor assessments q6 weeks until documented disease progression or new cancer therapy. Follow up q6 weeks for survival until death or data cut-off date.
    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 Decision2009-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-20
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