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    Summary
    EudraCT Number:2010-023062-40
    Sponsor's Protocol Code Number:PRP-001
    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:2010-11-24
    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 number2010-023062-40
    A.3Full title of the trial
    A Phase 1/2, First in Human, Single-arm, Open-label Study of Once a Day, Orally Administered Talazoparib (BMN 673) in Patients with Advanced or Recurrent Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of talazoparib (BMN 673), a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
    A.4.1Sponsor's protocol code numberPRP-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01286987
    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.
    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 code94105
    B.5.3.4CountryUnited States
    B.5.4Telephone number1415543 3470
    B.5.5Fax number1415543 3411
    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 BMN 673
    D.3.4Pharmaceutical form Capsule
    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 INNN/A
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeBMN 673
    D.3.9.3Other descriptive nameBMN 673ts
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeBMN 673
    D.3.9.3Other descriptive nameBMN 673ts
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeBMN 673
    D.3.9.3Other descriptive nameBMN 673ts
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 1373431-65-2
    D.3.9.2Current sponsor codeBMN 673
    D.3.9.3Other descriptive nameBMN 673ts
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Advanced or recurrent solid tumors for which there is no accepted standard treatment or for which standard treatment has failed. Patients may also be eligible if they are unable or decline to undergo standard therapy because it has limited antitumor efficacy or has significant toxicidty.
    E.1.1.1Medical condition in easily understood language
    Advanced or recurrent solid tumors for which there is no accepted standard treatment or for which standard treatment has failed.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to establish the maximum tolerated dose (MTD) of daily, oral BMN 673
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to:
    • assess the safety and tolerability of BMN 673
    • determine the PK profile of BMN 673
    • determine the Recommended Phase 2 Dose (RP2D) of BMN 673
    • assess preliminary efficacy of BMN 673
    • assess change in pharmacodynamic activity in blood, surrogate and/or fresh tumor tissue before and during treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed. Patients may also be eligible if they are unable or decline to undergo standard therapy because it has limited antitumor efficacy or has significant toxicity.
    • Must have available archived tumor tissue (formalin-fixed paraffin-embedded) [FFPE].
    • 18 years of age or older.
    • Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST,
    v1.1) or increased CA-125 (ovarian cancer) or prostate-specific antigen (PSA;
    prostate cancer), and/or CA 19-9 (pancreatic cancer).
    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
    • Have adequate organ function as defined below:
    o Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN); if liver function abnormalities are due to hepatic metastasis, then AST and ALT may be ≤ 5 X ULN;
    o Total serum bilirubin ≤ 1.5 X ULN;
    o Hemoglobin ≥ 9.0 g/dL with last transfusion at least 28 days before Cycle 1, Day 1;
    o Absolute neutrophil count (ANC) ≥ 1500/mm3;
    o Platelet count ≥ 100,000/mm3;
    • Able to take oral medications.
    • Willing and able to provide written, signed informed consent after the nature of the
    study has been explained, and prior to any research-related procedures.
    • Sexually active patients must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 30 days after the last dose of BMN 673.
    • Females of childbearing potential must have a negative serum pregnancy test at
    screening and be willing to have additional serum pregnancy tests during the study.
    Females considered not of childbearing potential include those who have been in
    menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or who have had total hysterectomy.
    • Willing and able to comply with all study procedures
    E.4Principal exclusion criteria
    • Has not recovered (recovery is defined as National Cancer Institute (NCI) Common
    Terminology Criteria for Adverse Events [CTCAE v4.03] grade ≤ 1) from the acute
    toxicities of previous therapy, except treatment-related alopecia or laboratory
    abnormalities otherwise meeting the inclusion requirements stated in the inclusion
    criterion.
    • Part 2 Expansion: Prior treatment with a PARP inhibitor.
    • Has history of central nervous system (CNS) metastasis.
    • Any antitumor systemic cytotoxic therapies within 28 days before Cycle 1, Day 1
    (6 weeks for nitrosoureas or mitomycin-C), treatment with immune modulators
    (including, but not limited to, corticosteroids, cyclosporine and tacrolimus; locally
    active treatments such as Beconase are allowed) within 28 days before Cycle 1,
    Day 1, or radiotherapy within 28 days before Cycle 1, Day 1.
    • Prior high-dose chemotherapy with bone marrow or stem cell transplant
    • Is known to have human immunodeficiency virus (HIV) or has active hepatitis C
    virus (HCV), or active hepatitis B virus (HBV).
    • Has had major surgery within 28 days before Cycle 1, Day 1.
    • Has active peptic ulcer disease.
    • Active gastrointestinal tract disease with malabsorption syndrome.
    • Requirement for IV alimentation.
    • Prior surgical procedures affecting absorption.
    • Uncontrolled inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
    • Myocardial infarction within 6 months before starting therapy, symptomatic
    congestive heart failure (New York Heart Association > class II), unstable angina, or
    unstable cardiac arrhythmia requiring medication
    • Breastfeeding at screening or planning to become pregnant (self or partner) at any
    time during study participation.
    • Use of any investigational product or investigational medical device within 28 days
    before Cycle 1, Day 1.
    • Concurrent disease or condition that would interfere with study participation or
    safety, such as:
    o Active, clinically significant infection requiring the use of parenteral antimicrobial
    agents, or grade > 2 by NCI CTCAE (v4.03) within 14 days before
    Cycle 1, Day 1;
    o Clinically significant bleeding diathesis or coagulopathy, including known
    platelet function disorders;
    o Non-healing wound, ulcer, or bone fracture.
    o Bone marrow disorder including myelodysplasia
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    The following safety outcome(s) measurements(s) will be assessed:
    • incidence of adverse events (AEs) and dose limiting toxicities (DLTs)
    • change in clinical laboratory tests (serum chemistry and hematology)
    • change in electrocardiogram (ECG) results
    • change in vital signs
    • change in physical examination
    • change in concomitant medication use
    Additional safety assessments may be made at any time if clinically indicated.

    Efficacy:
    A preliminary assessment of efficacy is a secondary objective of this study. The following efficacy measurements will be assessed:
    • objective response rate (ORR), as determined by the RECIST (v1.1) in patients with measurable solid tumors (Eisenhauer, 2009, Eur.J.Cancer); or as determined by measurement prostate-specific antigen (PSA; in patients with prostate cancer) or CA-125 (for patients with ovarian cancer) and/or CA 19-9 (for patients with pancreatic cancer) assessed with standard guidelines (Rustin, 2004, J Natl.Cancer Inst.), (Scher, 2008, J Clin Oncol), (Melnik, 2010, Mol.Cancer Ther.).
    Postbaseline tumor assessments will be performed using the same method as at baseline. Samples for tumor markers will be collected if appropriate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed after each visit until completion of Part 1 (Estimated duration is 12-18 months)
    E.5.2Secondary end point(s)
    •Number of participants with adverse events
    •Determine the pharmacokinetic (PK) profile of BMN 673
    •Determine the Recommended Phase 2 Dose (RP2D) of oral daily BMN 673
    •Assess preliminary efficacy of BMN 673 by Response Rate, based on RECIST (Response Evaluation Criteria In Solid Tumors)
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Assessed after each visit until completion of the study (Estimated duration is 24-30 months)
    •Assessed at each visit in cycle 1 - 5 (Estimated duration is 24 months)
    •Assessed after each visit until completion of the study (Estimated duration is 24-30 months)
    •Assessed approximately every 8 weeks (Estimated duration is 24-30 months)
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose Escalation/MTD (maximum tolerated dose)
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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
    Last visit of the last subject undergoing the trial
    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 months0
    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 months0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 40
    F.4.2.2In the whole clinical trial 95
    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)
    Expected normal treatment of the condition
    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 Decision2010-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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