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    Summary
    EudraCT Number:2017-004009-42
    Sponsor's Protocol Code Number:I4D-MC-JTJN
    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:2018-01-22
    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 number2017-004009-42
    A.3Full title of the trial
    A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study in Patients with advanced Ovarian Cancer
    A.4.1Sponsor's protocol code numberI4D-MC-JTJN
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center
    B.5.3.2Town/ cityDC 1526 Indianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2606368
    D.3.2Product code LY2606368
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLY2606368
    D.3.9.2Current sponsor codeLY2606368
    D.3.9.4EV Substance CodeSUB176839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number67
    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
    Patients with platinum-resistant or platinum-refractory high-grade serious ovarian, primary peritoneal, or fallopian tube cancer who have failed standard of care treatment.
    E.1.1.1Medical condition in easily understood language
    Patients with Ovarian 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 10066697
    E.1.2Term Ovarian cancer recurrent
    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 PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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 PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian 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 PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 PT
    E.1.2Classification code 10016182
    E.1.2Term Fallopian tube 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 PT
    E.1.2Classification code 10061269
    E.1.2Term Malignant peritoneal neoplasm
    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 estimate the overall response rate for each cohort (Cohort 1: Platinum-resistant, BRCA negative, and received ≥3 lines of prior therapy, Cohort 2: Platinum-resistant, BRCA negative, and received <3 lines of prior therapy, Cohort 3: Platinum-resistant, BRCA positive, there is no restrictions on number of lines
    of prior therapy, but patients must have received prior PARP inhibitor, Cohort 4: Platinum-refractory, BRCA positive or negative, no restrictions on number of
    lines of prior therapy)
    E.2.2Secondary objectives of the trial
    1. To characterize the safety and toxicity
    profile of prexasertib, 2. To characterize the PK of prexasertib, 3. To estimate secondary efficacy
    measures including DCR (disease control rate), DoR (duration of response), CA-125 response, PFS (progressioin free survival), OS (overall survival)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women who have histologically or cytologically verified high-grade serous ovarian,
    primary peritoneal or fallopian tube cancer.
    - Cohorts 1 to 3: Have platinum-resistant disease, which is defined as disease
    progression within 6 months of last dose of platinum-based chemotherapy.
    - Cohort 4: Have primary platinum-refractory disease defined as disease progression
    during or within 4 weeks after the last dose of initial line of platinum-based
    chemotherapy.
    - Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy for
    high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
    immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
    - Cohort 2: Are BRCA negative have received less than 3 prior lines of therapy for
    high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (including
    immunotherapy, targeted therapies, or chemotherapy (systemic or intraperitoneal).
    - Cohort 3: Are BRCA positive and have previously received a PARP inhibitor at any
    time following diagnosis.
    - Cohort 4: Are BRCA positive or negative; no restriction on number of lines of prior
    therapy.
    - Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group
    (ECOG) scale
    - Have adequate organ function,
    - Must be able and willing to undergo mandatory tumor biopsy which will be collected following determination of eligibility and before treatment (≤28 days before C1D1). Note that the biopsy may be collected prior to the predose Cycle 1 Day 1 pregnancy test and labs.
    E.4Principal exclusion criteria
    - Cohorts 1-3: Have previously received all of the following agents at any time in the
    platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and
    paclitaxel. It is acceptable to have received 1 or 2 of these agents for platinumresistant
    disease.
    - Have known central nervous system (CNS) malignancy or metastasis.
    - Have a known serious medical condition (e.g., active infection, increased risk of bleeding events) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol or tolerate the study treatment.
    - Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.
    - Have at least one of the following:
    history of abdominal fistula or gastrointestinal (GI) perforation
    intra-abdominal abscess within last 3 months prior to the first dose of study drug
    a radiographically confirmed bowel obstruction (including sub-occlusive disease)
    within 3 months prior to the first dose of study drug.
    - Have a symptomatic human immunodeficiency virus (HIV) infection or symptomatic
    activated/reactivated hepatitis A, B, or C (screening is not required).
    - Have a serious cardiac condition, such as:
    symptomatic congestive heart failure or any uncontrolled cardiac disease
    New York Heart Association Class III/IV heart disease
    unstable angina pectoris
    symptomatic or poorly controlled cardiac arrhythmia
    myocardial infarction within the last 3 months
    have a QT interval using Fridericia’s correction (QTcF) of >480 msec on more
    than one electrocardiogram (ECG) obtained during the baseline (screening) period
    family history of long-QT syndrome.
    - Have a history of prior radiotherapy to the whole pelvis.
    - Have chronic daily treatment with corticosteroids (dose >10 mg/day methylprednisolone
    equivalent), excluding inhaled and topical steroids.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate: proportion of all enrolled patients who achieve a best overall response of PR+CR as determined per RECIST version 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR will be performed when all enrolled patients have completed ≥2 months of follow-up and/or investigator-assessed best response assessments have been completed for all patients.
    E.5.2Secondary end point(s)
    safety & toxicity: The safety endpoints evaluated will include but are not limited to the following: AEs, SAEs, clinical laboratory tests, ECGs vital signs, and physical examinations
    PK: Prexasertib concentrations in plasma
    secondary efficacy measures including DCR, DoR, CA-125 response, PFS, OS: DCR: proportion of patients who achieve a best overall
    response of CR, PR and SD (for at least 4 months) as
    determined per RECIST version 1.1.
     DoR: time from the date measurement criteria for CR or PR
    (whichever is first recorded) are first met until the first date of
    documented PD, per RECIST 1.1 criteria, or the date of death
    from any cause in the absence of documented PD.
     CA-125 response: at least a 50% reduction in CA-125 levels from a
    pretreatment sample that is at least twice the upper limit of the
    reference range and obtained within 2 weeks before starting the
    treatment, with confirmation after 4 weeks according to GCIG
    criteria.
     PFS: time from enrollment until the first radiographic
    documentation (as assessed by the investigator) of
    progression or death from any cause in the absence of
    documented PD
     OS: time from enrollment until death from any cause
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated at the time of the primary endpoint analysis
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health outcome
    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 No
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Brazil
    Israel
    Korea, Republic of
    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 years1
    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 years1
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 180
    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)
    Patients who are still on prexasertib at the time of study completion may continue to receive prexasertib if they are experiencing clinical benefit and no undue risks. Lilly may allow patients to enroll in a “rollover” protocol to provide long-term continued access for patients enrolled in this study.
    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 Decision2018-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
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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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