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    Summary
    EudraCT Number:2016-002036-32
    Sponsor's Protocol Code Number:MDV3800-06(C3441006)
    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:2016-09-15
    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 number2016-002036-32
    A.3Full title of the trial
    TALAPRO 1: A PHASE 2, OPEN LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study to evaluate the effectiveness of Talazoparib in men with a genomic defect and metastatic castration-resistant prostate cancer who received previous chemotherapy and progressed on hormonal treatment
    A.4.1Sponsor's protocol code numberMDV3800-06(C3441006)
    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 SponsorMedivation, Inc. a wholly owned subsidiary of Pfizer Inc.
    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 supportMedivation, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedivation, Inc.
    B.5.2Functional name of contact pointMedical Officer
    B.5.3 Address:
    B.5.3.1Street Address525 Market Street, 36th Floor
    B.5.3.2Town/ citySan Francisco
    B.5.3.3Post codeCA 94105
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 4155433470
    B.5.5Fax number1 4155433411
    B.5.6E-maildg-MDV3800-06@medivation.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 nameTalazoparib
    D.3.2Product code PF-06944076
    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 INNTalazoparib
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codePF-06944076
    D.3.9.3Other descriptive nameMV3800 and BMN 673
    D.3.9.4EV Substance CodeSUB122393
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 nameTalazoparib
    D.3.2Product code PF-06944076
    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 INNTalazoparib
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codePF-06944076
    D.3.9.3Other descriptive nameMV3800 and BMN 673
    D.3.9.4EV Substance CodeSUB122393
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone)
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    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 PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 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
    To evaluate the efficacy of single agent talazoparib in DNA damage repair (DDR) + metastatic CRPC, as measured by best objective response rate (ORR).
    E.2.2Secondary objectives of the trial
    To evaluate efficacy with respect to the following parameters:
    -Time to objective response;
    -Duration of response;
    -Proportion of patients with prostate-specific antigen (PSA) decrease ≥ 50%;
    -Proportion of patients with conversion of circulating tumor cell (CTC) count;
    -Time to PSA progression;
    -Radiographic progression-free survival (PFS);
    -Overall survival.
    To evaluate the safety of talazoparib in this patient population.
    To evaluate the following patient-reported outcomes:
    -Time to deterioration in pain as assessed by the Brief Pain Inventory Short Form
    (BPI-SF);
    -Change from baseline in pain per BPI-SF;
    -Change from baseline in general health status as assessed by the European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L).
    To evaluate the pharmacokinetics (PK) of talazoparib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.For patients who are at least 18 years of age, there must be evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    2.Histologically or cytologically confirmed adenocarcinoma of the prostate without signet cell, or small cell features. Histologic confirmation may be based on a de novo tumor biopsy obtained for purposes of screening. Biopsies of the brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel may not be performed for the sole purpose of determining study eligibility.
    3.Patients must have measurable soft tissue disease per RECIST1.1.
    4.DNA damage repair gene alterations likely to sensitize to PARP inhibition (DDR positive) as determined by:
    •Prospective testing of de novo or archival tumor tissue (via central laboratory) or prior historical (with Sponsor preapproval) testing of tumor tissue using the Foundation Medicine, FoundationOne® NGS gene panel test;
    Archival or de novo tumor tissue also should be submitted prior to Day 1 if possible to support concordance analyses and additional molecular profiling.
    5.Unless prohibited by local regulations or ethics committee (EC) decision, consent to a saliva sample collection for retrospective sequencing of DDR genes used to assess patient eligibility based on tumor tissue, and to serve as a germline control in identifying tumor mutations.
    6.Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.
    7.Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).
    8.Progressive disease at study entry defined as 1 or more of the following 3 criteria:
    •A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ≥ 2 μg/L (2 ng/mL) if qualifying solely by PSA progression.
    •Soft tissue disease progression as defined by RECIST 1.1.
    •Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions on bone scan.
    9.Metastatic disease. Patients whose only evidence of metastasis is measurable soft tissue disease below the aortic bifurcation will be acceptable. Neither bone metastases on bone scan nor non- measurable soft tissue disease alone will qualify a patient.
    10.Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane based regimen for metastatic (non castrate or castrate) prostate cancer. Patients may have received radium 223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
    11.Documented disease progression (either radiographic or biochemical) on at least 1 novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) for the treatment of metastatic CRPC, irrespective of prior NHT treatment for non castrate prostate cancer or nonmetastatic (M0) CRPC.
    12.Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
    13.ECOG performance status of 0 to 2.
    14.Estimated life expectancy of ≥ 6 months as assessed by the investigator.
    15.Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.
    16.Must use a condom when having sex with a pregnant woman from the time of the first dose of study drug through 105 days after last dose of study drug. An additional highly effective form of contraception (Section 4.3.1) must be used from the time of the first dose of study drug through 105 days after last dose of study drug when having sex with a non pregnant female partner of childbearing potential.
    17.Must agree not to donate sperm from the first dose of study drug to 105 days after the last dose of study drug.
    18.Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.


    E.4Principal exclusion criteria
    1.Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
    2.Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone chemotherapy. Patients who discontinued prior platinum based chemotherapy  6 months prior to screening or whose disease previously progressed on platinum based therapy at any time in the past are also excluded.
    3.Treatment with any concurrent cytotoxic chemotherapy or investigational drug(s) within 4 weeks or 5 half lives of the drug (whichever is longer) before Day 1 and/or during study participation.
    4.Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
    5.Major surgery within 2 weeks before day 1.
    6.Clinically significant cardiovascular disease, including any of the following:
    •Myocardial infarction or symptomatic cardiac ischemia within 6 months before screening.
    •Congestive heart failure New York Heart Association class III or IV.
    •History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening.
    •History of Mobitz II second degree or third degree heart block unless a permanent pacemaker is in place.
    •Hypotension as indicated by systolic blood pressure < 86 mm Hg at screening.
    •Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram.
    •Uncontrolled hypertension as indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening.
    7.Significant organ dysfunction as defined by any one of the following laboratory abnormalities:
    •Renal: eGFR < 30 mL/min /1.73 m2 by the MDRD equation (Modification of Diet in Renal Disease [available via www.mdrd.com]).
    •Hepatic:
    •Total serum bilirubin > 1.5 times the upper limit of normal (ULN) (> 3 × ULN for patients with Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation);
    •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5 times ULN (if liver test abnormalities are due to hepatic metastasis, then AST or ALT ≥ 5 × ULN);
    •Albumin < 2.8 g/dL.
    •Bone marrow reserve: absolute neutrophil count < 1500/μL, platelets < 100,000/μL, or hemoglobin < 9 g/dL (NOTE: may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening).
    8.Known or suspected brain metastasis or active leptomeningeal disease.
    9.Symptomatic or impending spinal cord compression or cauda equina syndrome.
    10.Diagnosis of myelodysplastic syndrome.
    11.History of another cancer within 3 years before enrollment with the exception of nonmelanoma skin cancers, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
    12.Gastrointestinal disorder affecting absorption.
    13.Current or anticipated use of the following P gp inhibitors (amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, verapamil, and valspodar), P gp inducers (avasimibe, carbamazepine, phenytoin, rifampin, and St. John’s wort), or BCRP inhibitors (curcumin, cyclosporine, elacridar [GF120918] and eltrombopag).
    14.Any other acute or chronic medical or psychiatric condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor, including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product 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.
    15.Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    16.Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 105 days after the last dose of investigational product.
    E.5 End points
    E.5.1Primary end point(s)
    Best objective response rate (ORR).The proportion of patients with a best overall
    soft tissue response of CR or PR per RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint analysis will be performed when the last enrolled patient completes at least 6 months of study drug treatment, withdraws consent, discontinues from the study, or dies, whichever occurs first.
    E.5.2Secondary end point(s)
    - Time to objective response
    - Duration of response
    - Proportion of patients with conversion of CTC count
    - Time to PSA progression
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Time to objective response: time from enrollment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3.
    - Duration of response: time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST 1.1 by independent central review and no evidence of confirmed bone disease progression per PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occurs first.
    -CTC assessment at weeks 1,9,17,25, safety follow up
    -PSA assessment at weeks 1,9,13,17,21,25, safety follow up
    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 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
    Exploratory biomarker assessments: Sufficient fresh or archival tumor tissue must be submitted for whole exome sequencing, homologous recombination deficiency (HRD) analysis, and transcriptome studies.Blood samples for circulating tumor cells (CTC), circulating tumor DNA (ctDNA), and protein biomarker analyses will be collected throughout the study.
    Saliva samples will be collected to serve as a germline DNA sequencing comparator to assist in identifying tumor tissue mutations.
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA61
    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
    Denmark
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    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
    LVLS
    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 months6
    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 months7
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 70
    F.4.2.2In the whole clinical trial 100
    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)
    None
    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 Decision2016-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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