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    Summary
    EudraCT Number:2012-001038-32
    Sponsor's Protocol Code Number:8-55-58102-002
    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:2012-07-30
    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 number2012-001038-32
    A.3Full title of the trial
    A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROOF OF CONCEPT STUDY OF MAINTENANCE THERAPY WITH TASQUINIMOD IN PATIENTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER WHO ARE NOT PROGRESSING AFTER A FIRST LINE DOCETAXEL BASED CHEMOTHERAPY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PROOF OF CONCEPT STUDY OF MAINTENANCE THERAPY WITH TASQUINIMOD IN PATIENTS WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER WHO ARE NOT PROGRESSING AFTER A FIRST LINE DOCETAXEL BASED CHEMOTHERAPY
    A.4.1Sponsor's protocol code number8-55-58102-002
    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 SponsorIpsen Pharma
    B.1.3.4CountryFrance
    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 supportIpsen Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Pharma
    B.5.2Functional name of contact pointVP Worldwide Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address65 quai Georges Gorse
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.6E-mailct-application@ipsen.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 nametasquinimod
    D.3.2Product code ABR-215050
    D.3.4Pharmaceutical form Capsule, hard
    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 INNtasquinimod
    D.3.9.1CAS number 254964-60-8
    D.3.9.2Current sponsor codeABR-215050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.25 to 1
    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) 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 No
    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 placeboCapsule, hard
    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
    maintenance therapy in metastatic Castrate Resistant Prostate Cancer patients who are not progressing under/after a first line docetaxel based chemotherapy
    E.1.1.1Medical condition in easily understood language
    maintenance therapy in metastatic Castrate Resistant Prostate Cancer patients who are not progressing under/after a first line docetaxel based chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 the clinical efficacy (i.e. radiological progression free survival [PFS]) of tasquinimod maintenance therapy with placebo in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not progressed after a first line docetaxel based chemotherapy.
    E.2.2Secondary objectives of the trial
    To further evaluate the safety profile of tasquinimod
    To compare other clinical benefits (such as overall survival, PFS on next-line therapy [PFS 2] and symptoms) of tasquinimod with placebo
    To evaluate the impact of tasquinimod on health related quality of life (QoL)
    To further characterise the pharmacokinetics (PK) of tasquinimod using a population approach.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients must fulfil the following criteria to participate in the study:
    (1)Has provided written informed consent
    (2)Histologically documented prostate cancer with evidence of metastatic disease on radiological evaluation, with or without symptoms (defined according to the brief pain inventory [BPI] scale, with use of analgesics or narcotics)
    (3)Has received a first line docetaxel based chemotherapy (as a monotherapy) every 3 weeks schedule of administration with corticosteroids for a minimum of 6 cycles with a cumulative dose ≥360 mg/m2. Any combination with investigational or non investigational agent is prohibited
    (4)Male aged ≥18 years old
    (5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    (6)Docetaxel-related adverse effects must have been resolved to NCI-CTCAE v4.03 Grade ≤1. Chemotherapy-induced alopecia and Grade 2 peripheral neuropathy are allowed
    (7)No progressive disease at the end of docetaxel treatment defined according to RECIST criteria, no new lesion(s) assessed by bone scan and no elevated PSA for the three last tests with PSA3≤PSA2≤PSA1. The time between each PSA test should be preferably at least 14 days, however, a minimum of 7 days is acceptable.
    Note: PSA value can be rounded to the nearest whole number if PSA>10 ng/mL. If the PSA3 value is above the PSA2, a fourth PSA test will be performed. The PSA4 value should be below or equal to PSA2.
    (8)Last dose of docetaxel administered between 21 and 42 days before randomisation
    (9)Chemical or surgical castration verified by levels of serum testosterone ≤50 ng/dL (1.75 nmol/L)
    (10)A life expectancy of at least 12 weeks in the judgment of the Investigator
    (11)The following laboratory values within 14 days prior to randomisation:
    •Haematology
    -Absolute granulocytes ≥1.5 x 109/L
    -Platelets ≥100 x 109/L
    -Haemoglobin ≥9 g/dL transfusions allowed, epoetin alfa allowed only if last administration >2 weeks before randomisation
    •Biochemistry
    -Bilirubin ≤1.5 x upper limit of normal (ULN)
    -Serum creatinine ≤1.5 x ULN or calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula ≥60 mL/min
    -Alanine aminotransferase/ aspartate aminotransferase ≤3 x ULN (≤5 x ULN if liver metastases present)
    (12)If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive method (barrier contraceptive with spermicide) while receiving study treatment and until 14 days after the stop of study treatment or have been previously vasectomised
    (13)Able to swallow and retain oral drug
    (14)Able to adhere to the study visit schedule and other protocol requirements
    (15)Must be available for treatment, evaluation assessments and follow-up at the study centres
    (16)Able to comprehend the full nature and purpose of the study, including possible risks and side effects, and to cooperate with the Investigator and to comply with the requirements of the entire study.
    E.4Principal exclusion criteria
    A patient will not be included in the study if he:
    (1)Has concurrent use of other anticancer agents or treatments, with the following exceptions: ongoing treatment with luteinising hormone-releasing hormone agonists or antagonists, denosumab or bisphosphonate (e.g. zoledronic acid) is permitted if started ≥4 weeks prior to Screening. Ongoing treatment should be kept at a stable dose regimen
    (2)Has ongoing treatment with warfarin
    (3)Had prior radiation therapy since starting docetaxel. Exceptions may be made for palliative non-myelosuppressive radiation therapy administered more than 2 weeks prior to randomisation
    (4)Had prior strontium, samarium or radium therapy or prior treatment with tasquinimod, or any agents with antiangiogenic properties
    (5)Has ongoing treatment with corticosteroids at >10 mg/day prednisolone equivalent
    (6)Has prostate cancer pain that warrants the initiation of radiotherapy or chemotherapy
    (7)Has known hypersensitivity to the study treatment, to any of its excipients or treatments with a similar chemical structure
    (8)Has ongoing treatment with cytochrome P450 (CYP) 1A2 or CYP3A4 metabolised drug substance with narrow therapeutic range at the start of study treatment
    (9)Has a systemic exposure to ketoconazole or other strong CYP3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not permitted within 1 year prior to the start of study treatment
    (10)Has simultaneous participation in any other study involving treatment with investigational drugs or device or has received treatment with investigational drugs less than 4 weeks prior to randomisation
    (11)Has myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, New York Heart Association (NYHA) class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within 6 months prior to randomisation, has history of venous thrombo-embolic disease within 3 months prior to randomisation and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension and uncontrolled atrial or ventricular arrhythmias
    (12)Has history of pancreatitis
    (13)Has known brain or epidural metastases. Patients with previous medullary cord compression without any neurological deficit could be included
    (14)Has known positive serology for human immunodeficiency virus
    (15)Has chronic hepatitis with advanced, decompensated hepatic disease, cirrhosis of the liver, history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be permitted to enter the study)
    (16)Has active tuberculosis (TB), or with known, untreated latent TB. Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and patient should intend to complete the entire course of that therapy
    (17)Has any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of clinically significant laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study
    (18)Should not participate in the study in the opinion of the Investigator
    (19)Is currently receiving immunosuppressive therapy
    (20)Has a history of major surgery 4 weeks prior to randomisation, or has an incompletely healed surgical incision
    (21)Has a history of other malignancies, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated, without evidence of disease for >5 years
    (22)Is deprived of his freedom or rights by virtue of an order issued either by any judicial or administrative authorities, is unable to express his consent, or is committed to a health institution for reasons other than the study
    (23)Has a history of, or known current, problems with drug or alcohol abuse
    (24)Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is radiological PFS including skeleton related events, defined as the time from the date of randomisation to the date of radiological progression or death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    assessment every 8 weeks until radiological progression
    E.5.2Secondary end point(s)
    • Overall survival, defined as the time from randomisation to death due to any cause
    • Symptomatic PFS, defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first (symptomatic progression as assessed by Pain BPI and analgesic use)
    • Time from randomisation to further treatment for prostate cancer
    • QoL measured by the Functional Assessment of Cancer Therapy Prostate Module (FACT P) questionnaire and by the EuroQol-5 Dimension QoL Instrument (EQ 5D)
    • PK measurements of tasquinimod.
    • PFS on next-line therapy (PFS 2)
    • Complete physical examination including the evaluation of performance status (ECOG), vital signs measurements and body weight
    • Electrocardiogram findings
    • Clinical laboratory assessments
    • Adverse events.


    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see schedule of assessment (pages 10-12 of the protocol)
    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 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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 study will be considered to have finished (end of study) when 80% of the patients have died or 2 years after the last patient randomised, whichever occurs last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 98
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    Treatment after the subject has ended the participation in the trial will be let to investigator's judgement.
    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 Decision2012-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
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