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    Summary
    EudraCT Number:2016-004429-17
    Sponsor's Protocol Code Number:CO39303
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-05-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-004429-17
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL TESTING IPATASERTIB PLUS ABIRATERONE PLUS PREDNISONE/PREDNISOLONE, RELATIVE TO PLACEBO PLUS ABIRATERONE PLUS PREDNISONE/PREDNISOLONE IN ADULT MALE PATIENTS WITH ASYMPTOMATIC OR MILDLY SYMPTOMATIC, PREVIOUSLY UNTREATED, METASTATIC CASTRATE-RESISTANT PROSTATE CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer
    A.4.1Sponsor's protocol code numberCO39303
    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 SponsorF. Hoffmann-La Roche Ltd
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameipatasertib 100mg
    D.3.2Product code RO5532961
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNipatasertib
    D.3.9.2Current sponsor codeRO5532961
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.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 nameipatasertib 200mg
    D.3.2Product code RO5532961
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNipatasertib
    D.3.9.2Current sponsor codeRO5532961
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Tablet
    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 INNAbiraterone acetate
    D.3.9.1CAS number 154229-18-2
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Metastatic Castrate-Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer is the development of cancer in the prostate, a gland in the male reproductive system
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate To evaluate the efficacy in the intent to treat (ITT) population
    • To evaluate the efficacy in patients with PTEN-loss tumors by immunohistochemistry (IHC)
    E.2.2Secondary objectives of the trial
    • To evaluate the clinical benefit in the ITT population, and in patients with PTEN-loss tumors by IHC
    • To evaluate the efficacy in patients with Phosphatase and tensin homolog (PTEN)-loss tumors by next-generation sequencing
    • To evaluate the safety in the ITT population and in patients with PTEN-loss tumors by IHC
    • To characterize ipatasertib and abiraterone pharmacokinetics
    • To characterize ipatasertib exposure, abiraterone exposure in relation to efficacy and safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged >= 18 years
    - Eastern Cooperative Oncology Group performance status of 0 or 1
    - Adequate hematologic and organ function test results within 28 days before the first study treatment
    - Life expectancy of at least 6 months
    - Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in the protocol
    - For enrollment into the China extension cohort, residence in the People's Republic of China
    Disease-Specific Inclusion Criteria:
    - Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
    - Consent to provide a formalin-fixed, paraffin-embedded tissue block or a minimum of 15 freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report
    - A valid PTEN IHC result
    - Metastatic disease documented prior to randomization by clear evidence of bone lesions by bone scan and/or measurable soft tissue disease by computed tomography (CT) and/ or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors, Version 1.1(RECIST v1.1)
    - Asymptomatic or mildly symptomatic form of prostate cancer
    - Progressive disease before initiating study treatment, defined using at least one of the following criteria:
    . Two rising prostate-specific antigen (PSA) levels measured >= 1 week apart with second result >= 1 ng/mL according to Prostate Cancer Working Group 3 (PCWG3) criteria (Patients who have received an anti-androgen therapy must have PSA progression after withdrawal [>= 4 weeks since last flutamide or >= 6 weeks since last treatment of bicalutamide or nilutamide])
    . Radiographic evidence of disease progression in soft tissue according to RECIST v1.1 and/or bone scan according to PCWG3 criteria
    - Ongoing androgen deprivation with gonadotropin-releasing hormone analog or bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 2.0 nmol/L) within 28 days before randomization
    E.4Principal exclusion criteria
    -Inability or unwillingness to swallow whole pills
    -History of malabsorption syndrome/other condition that would interfere with enteral absorption
    -Clinically significant history of liver disease consistent with Child-Pugh Class B or C including cirrhosis, current alcohol abuse or current known active infection with hepatitis B or B virus
    .Patients positive for anti-HBc are eligible only if test results are negative for HBsAg and polymerase chain reaction is negative for HBV DNA
    .Patients positive for HCV serology are eligible only if testing for HCV RNA is negative
    -Need of more than 10 mg/day of prednisone or equivalent dose of other anti-inflammatory corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease
    -Active infection requiring intravenous antibiotics within 14 days before Day1 Cycle 1 (D1 C1)
    -History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
    -History of another malignancy within 5 years prior to randomization except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of <5% at 5 years
    -Any other diseases, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patients at high risk from treatment complications
    Disease-Specific Exclusion Criteria
    -Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate
    -Any therapy including chemotherapy or biological therapy for the treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-α reductase inhibitor is permitted
    -In the setting of chemotherapy received for hormone-sensitive prostate cancer, treatment with chemotherapy initiated more than 6 months after time of first castration (delayed initiation of chemotherapy for HSPC). Patients should not have progressed during/within 3 months after the completion of chemotherapy-based treatment (rapid progression on chemotherapy for HSPC)
    -Use of opioid medication for cancer-related pain including codeine and dextropropoxyphene currently or any time within 4 weeks of D1 C1
    -Prior treatment with abiraterone/other known potent CYP17 inhibitors or investigational agents that block androgen synthesis. Prior treatment with itraconazole and fluconazole is permitted
    -Prior treatment with enzalutamide/other potent androgen-receptor blockers approved or experimental
    -Prior treatment with flutamide, steroidal anti-androgens, androgens or estrogens treatment within 4 weeks of C1 D1
    -Prior treatment with bicalutamide/nilutamide within 6 weeks of C1 D1
    -Prior treatment with 5α reductase inhibitors within 4 weeks of C1 D1
    -Prior treatment with systemic radiopharmaceuticals (except for imaging). Focal palliative radiation to treat cancer-related pain is permitted provided that the last treatment with radiation is at least 14 days prior to C1 D1
    -Prior treatment with approved or experimental therapeutic agents with known inhibition of the PI3K pathway, including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors
    -Administration of an investigational therapeutic agent within 28 days of C1 D1
    -Known untreated or active central nervous system (CNS) metastases
    -Patients with a history of treated CNS metastases are eligible provided they meet all of the following criteria:
    .An evaluable or measurable disease according to the inclusion criteria outside the CNS
    .Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
    .No history of intracranial hemorrhage or spinal cord hemorrhage
    .Minimum of 2 weeks between completion of radiotherapy and D1 C1 and recovery from significant (Grade >= 3) acute toxicity, with no ongoing requirement for >= 10 mg/day of prednisone or an equivalent dose of another corticosteroid
    -Any chronic therapy or use of food supplement that is a strong CYP3A4/5 inhibitor or inducer, or sensitive CYP3A substrates with a narrow therapeutic window
    Abiraterone-Specific Exclusion Criteria
    -Uncontrolled hypertension
    -History of pituitary or adrenal dysfunction
    -Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy
    Ipatasertib-Specific Exclusion Criteria
    -Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
    -History of inflammatory bowel disease and active bowel inflammation
    E.5 End points
    E.5.1Primary end point(s)
    1) Investigator-assessed radiographic progression-free survival (rPFS), per PCWG3 criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Approximately 7 years
    E.5.2Secondary end point(s)
    1) Overall survival
    2) Time to pain progression
    3) Time to initiation of cytotoxic chemotherapy for prostate cancer
    4) Time to function deterioration per European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 physical function and role functioning
    5) Time to PSA progression, per the PCWG3 criteria
    6) Time to first opioid use
    7) Time to symptomatic skeletal events
    8) Objective response rate, per RECIST v1.1 and PCWG3 criteria in patients with measurable disease
    9) PSA response rate
    10) Investigator-assessed rPFS per PCWG3 criteria
    11) Incidence, nature, and severity of adverse events
    12) Plasma concentration of ipatasertib and abiraterone
    13) Relationship between plasma concentration or PK parameters of ipatasertib and abiraterone, via safety and efficacy endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-11. Approximately 7 years
    12-13. Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, and Cycle 6 Day 1
    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 Yes
    E.6.13.1Other scope of the trial description
    clinical benefit
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    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
    Austria
    Belgium
    Brazil
    Canada
    China
    Costa Rica
    Denmark
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Norway
    Poland
    Portugal
    Russian Federation
    Slovenia
    Spain
    Sweden
    Taiwan
    Thailand
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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: 275
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 825
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 517
    F.4.2.2In the whole clinical trial 1100
    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 Sponsor will offer post-trial access to the study drug ipatasertib free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product
    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 Decision2017-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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