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    Summary
    EudraCT Number:2009-012709-20
    Sponsor's Protocol Code Number:LF-0207
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-07
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-012709-20
    A.3Full title of the trial
    A Phase 3, randomized, double-blind, placebo-controlled study of oral talactoferrin in addition to best supportive care in patients with non-small cell lung cancer who have failed two or more prior treatment regimens.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Talactoferrin in Previously Treated Patients With
    Non-small Cell Lung Cancer
    A.3.2Name or abbreviated title of the trial where available
    FORTIS-M
    A.4.1Sponsor's protocol code numberLF-0207
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00707304
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAgennix Incorporated
    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 supportAgennix Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Limited
    B.5.2Functional name of contact pointFORTISMstudy
    B.5.3 Address:
    B.5.3.1Street AddressStation House, Market Street,
    B.5.3.2Town/ cityBracknell, Berkshire
    B.5.3.3Post codeRG12 9YZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441344708508
    B.5.5Fax number00441344708105
    B.5.6E-mailFORTISMStudy@Quintiles.com
    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 nameTalactoferrinum alfa
    D.3.2Product code TLF
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    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 INNTalactoferrinum alfa
    D.3.9.1CAS number 308240-58-6
    D.3.9.2Current sponsor codeTLF
    D.3.9.3Other descriptive nameTalactoferrin alfa
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 placeboOral solution
    D.8.4Route of administration of the placeboOral use
    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 in patients who have failed two or more prior treatment regimens.
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Study:
    To determine overall survival.

    Extension Study (Appendix D for patients who continue after 5 cycles):
    To provide ongoing study drug to patients who previously completed all
    five cycles of study drug in the FORTIS-M (LF-0207) study and have no
    other available alternative therapies.
    E.2.2Secondary objectives of the trial
    Main Study:
    To determine six month and one year survival rate
    To determine progression-free survival
    To determine objective tumor response rate
    To determine disease stabilization rate
    To assess talactoferrin safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Study:
    1. Age ≥ 18 years.
    2. Histologically or cytologically confirmed stage IIIB or IV NSCLC
    3. Failed at least 2 prior systemic anti-cancer regimens for advanced or
    metastatic NSCLC. The following criteria must be satisfied:
    • Failure is defined as disease progression or unacceptable toxicity
    • The patient must have received a platinum-containing regimen for advanced or metastatic NSCLC
    • Failure to the most recent systemic anti-cancer regimen must have
    occurred
    4. At least one target lesion that is unirradiated and measurable by
    RECIST
    5. Hemoglobin ≥ 9.0 g/dL
    6. Absolute neutrophil count ≥ 2000/mm3
    7. Lymphocytes ≥ 800/mm3
    8. Platelet count ≥ 100,000/mm3
    9. Total bilirubin ≤ 1.5 mg/dL
    10. Creatinine ≤ 2.0 mg/dL
    11. AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN)
    12. Lactate dehydrogenase ≤ 1.5 x ULN
    13. Karnofsky performance status of >50 (ECOG 0, 1, or 2)
    14. Life expectancy of >12 weeks
    15. Able to understand and sign an informed consent

    Extension study:
    1. Completed Cycle 5 of study drug in the FORTIS-M (LF-0207) study
    2. No evidence of disease progression
    3. Overall medical condition sufficient to continue receiving study drug in
    the judgment of the investigator
    4. Able to understand and sign an informed consent
    E.4Principal exclusion criteria
    Main Study:
    1. Presence of brain metastases, unless the patient received brain
    irradiation, including adequate stereotactic radiosurgery, at least 4
    weeks prior to randomization, and is stable, asymptomatic, and off
    steroids for at least 3 weeks prior to randomization
    2. History of allergic reactions to compounds of similar chemical or
    biologic composition to talactoferrin
    3. Any gastrointestinal tract disease or other medical condition resulting
    in the inability to take oral medications
    4. History of other malignancies except: (i) adequately treated basal or
    squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ
    carcinoma of the uterine cervix, b) prostate cancer, or c) superficial
    bladder cancer; or (iii) other curatively treated solid tumor with no
    evidence of disease for ≥ 5 years
    5. Uncontrolled ischemic heart disease, or uncontrolled symptomatic
    congestive heart failure
    6. Serious active infection
    7. Psychiatric illness/ social situations that would limit study compliance
    8. Other uncontrolled serious chronic disease or conditions that in the
    investigator's opinion could affect compliance or follow-up in the
    protocol
    9. Concurrent radiotherapy to any site or radiotherapy within 4 weeks
    prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
    10. Known HIV positive or on active anti-retroviral therapy
    11. Known Hepatitis B surface antigen positive or hepatitis C positive
    12. Receipt of any systemic anti-cancer regimen or investigational
    medication within 4 weeks prior to randomization
    13. Pregnant or lactating patients, or fertile female patients with a
    positive pregnancy test (serum β-human chorionic gonadotropin [β-hCG] at screening or at baseline), or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment
    14. Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of
    treatment
    15. Legal incapacity or limited legal capacity, unless authorization is
    granted by a legal guardian
    16. Oral corticosteroid therapy within 4 weeks prior to randomization or
    expected to be ongoing during the study, except replacement therapy for adrenal insufficiency

    Extension Study:
    1. Prior Grade 3 or 4 adverse events attributed to study drug
    2. Any gastrointestinal tract disease or other medical condition resulting
    in the inability to take oral medications
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints Main Study

    • Overall Survival (OS)

    Efficacy Endpoints Extension Study
    • Progression-Free Survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Main Study:
    Continuously

    Extension Study:
    End of every cycle until disease progression
    E.5.2Secondary end point(s)
    Efficacy Endpoints Main Study
    • Six month and one year survival rate
    • Progression-Free Survival (PFS)
    • Objective Response Rate (ORR): radiologically confirmed partial
    response + complete response (PR+CR) using RECIST
    • Objective disease stabilization rate (PR+CR+stable disease [SD])

    Safety Endpoints Main Study
    • Number of adverse events per month while receiving study drugs
    • Number of Grade 3 or 4 adverse events per month while receiving study drugs
    • Incidence of Grade 3 or 4 adverse events
    • Incidence of Grade 3 or 4 pulmonary/upper respiratory adverse events
    • Incidence of Grade 3 or 4 gastrointestinal adverse events

    Extension Study:
    Assess talactoferrin safety and tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main Study:
    6 months and 1 year
    PFS at end of every cycle until disease progression
    ORR, PR+CR, PR+CR+stable disease at end of every cycle until disease
    progression
    Safety endpoints continuously

    Extension Study:
    Continuously
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    India
    Italy
    Korea, Republic of
    Latvia
    Malaysia
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    Spain
    Taiwan
    Turkey
    United Kingdom
    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
    Main study:
    Patients will be followed for survival for at least 12 months from the
    date of randomization or until the data cut-off for the principal analysis
    for the survival has occurred. The principal analysis of the overall
    survival will be calculated after 576 events. The statistical parameters
    calculated after 576 events should provide sufficient data to show IMP
    activity.

    Extension Study
    Last Patient, Last Visit
    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 days15
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 408
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 334
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 464
    F.4.2.2In the whole clinical trial 742
    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)
    The patient should receive the expected normal treatment after participation in the trial
    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 Decision2009-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-06
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