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    Summary
    EudraCT Number:2017-000607-25
    Sponsor's Protocol Code Number:KCP-330-024
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-27
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-000607-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer
    A.3.2Name or abbreviated title of the trial where available
    SIENDO:Selinexor in Endometrial Cancer
    A.4.1Sponsor's protocol code numberKCP-330-024
    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 SponsorKaryopharm Therapeutics 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 supportKaryopharm Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharm-Olam International (Polska) Sp. z o. o.
    B.5.2Functional name of contact pointClinical Operations Director Poland
    B.5.3 Address:
    B.5.3.1Street Address181 Al. Jerozolimskie
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-222
    B.5.3.4CountryPoland
    B.5.4Telephone number+4822290 1877
    B.5.5Fax number+4822290 1878
    B.5.6E-mailslawomir.debicki@pharm-olam.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 nameSelinexor
    D.3.2Product code KPT-330
    D.3.4Pharmaceutical form 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 INNSelinexor
    D.3.9.2Current sponsor codeKPT-330
    D.3.9.3Other descriptive nameSELINEXOR
    D.3.9.4EV Substance CodeSUB177942
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCoated tablet
    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
    Selinexor/placebo will be given as maintenance therapy after combination chemotherapy for patients with advanced endometrial cancer
    E.1.1.1Medical condition in easily understood language
    Selinexor/placebo will be given as maintenance therapy after combination chemotherapy for patients with advanced endometrial 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 10014733
    E.1.2Term Endometrial 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 10014734
    E.1.2Term Endometrial 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 10014736
    E.1.2Term Endometrial cancer recurrent
    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 and compare the efficacy of selinexor compared to placebo, as assessed by the investigator, as maintenance therapy in patients with advanced or recurrent endometrial cancer.
    E.2.2Secondary objectives of the trial
    To evaluate and compare the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review (BICR).
    To evaluate and compare selinexor and placebo for time to subsequent therapies.
    To evaluate and compare selinexor and placebo for efficacy on subsequent therapy.
    To evaluate and compare selinexor and placebo on survival rates.
    To evaluate and compare selinexor and placebo for disease control.
    To evaluate health-related quality of life (HR-QoL) outcomes.
    Assess the safety and tolerability of selinexor.
    Exploratory
    To evaluate and compare selinexor and placebo on tumor response rate
    To evaluate and compare selinexor and placebo on duration of response (DOR)
    To identify predictive biomarkers of response to treatment and explore treatment mechanism of action using genomics analyses
    To evaluate the PK of selinexor used as maintenance therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Female, at least 18 years of age at the time of informed consent.
    2.Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed.
    3.Meet at least 1 of the following:
    a.Stage IV disease, completed at least 12 weeks of first-line taxane-carboplatin combination therapy, and is in partial or complete remission according to RECIST v1.1
    b.Have relapsed after primary therapy, completed at least 12 weeks (4 cycles of 3-or 4 weekly or 12 courses of weekly) of paclitaxel-carboplatin combination therapy, and is in partial or complete remission according to RECIST v1.1
    c.Have relapsed after primary therapy with a paclitaxel-carboplatin combination, have received at least 12 weeks of a second-line chemotherapy, and is in partial or complete remission according to RECIST v1.1 on this second-line chemotherapy
    Note: Prior adjuvant for Stage I-III is not counted as a line of chemotherapy unless the relapse occurred within 6 months after the last adjuvant course of chemotherapy for stage I-III disease; chemotherapy prior to inclusion should be completed as planned and cannot be interrupted prematurely to enter the trial.
    4.Must be able to initiate study treatment 5 to 8 weeks after completion of their final dose of chemotherapy.
    5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    6.Patients must have an adequate organ function.
    a.Hepatic function: total bilirubin up to 1.5 x upper limit of normal (ULN); ALT and AST ≤2.5 x ULN in patients without liver metastasis. For patients with known liver involvement of their tumor: AST and ALT ≤5 x ULN.
    b.Absolute neutrophil count (ANC) ≥1.5 x 109/L; platelet count ≥100 x 109L; hemoglobin ≥10.0 g/dL
    c.Adequate renal function: estimated creatinine clearance (CrCl) of ≥30 mL/min, calculated using the formula of Cockroft and Gault.
    7.In the opinion of the Investigator, the patient must:
    a.Have a life expectancy of at least 12 weeks
    b.Be fit to receive experimental therapy
    8.Premenopausal females of childbearing potential must have a negative pregnancy test (serum β HCG test) prior to the first dose of study drug. Female patients of childbearing potential must agree to use must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
    9.Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
    E.4Principal exclusion criteria
    1.Has any sarcomas, small cell carcinoma with neuroendocrine differentiation, or clear cell carcinomas.
    2.Received a blood or platelet transfusion during 4 weeks prior to randomization.
    3.Being treated with a concurrent cancer therapy.
    4.Previous treatment with XPO1 inhibitor.
    5.Concurrent treatment with an investigational agent or participation in another clinical trial.
    6.Patients who received any systemic anticancer therapy including investigational agents or radiation ≤3 weeks (or ≤5 half-lives of the drug [whichever is shorter]) prior to C1D1. Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease (PD).
    7.Major injuries or surgery within 14 days prior to C1D1 and/or planned surgery during the on-treatment study period.
    8.Have had complete cytoreductive surgery (ie, no visible residual disease) prior to the last chemotherapy.
    9.Previous malignant disease, except patients with other malignant disease, for which the patient has been disease-free for at least 3 years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
    10.Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient’s safety or compliance with the protocol.
    11.Known contraindications to selinexor.
    12.Known uncontrolled hypersensitivity to the investigational drugs, or to their excipients.
    13.Radiotherapy to the target lesion within the past 3 months prior to baseline imaging.
    14.Persistent Grade 3 or 4 toxicity from previous chemotherapy and/or radiotherapy, with the exception of alopecia.
    15.Active brain metastases (eg, stable for <8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsants. Corticoid therapy is allowed if administered as stable dose for at least 1 month before randomization).
    16.Known unstable cardiovascular function:
    a.Symptomatic ischemia, or
    b.Uncontrolled clinically significant conduction abnormalities (ie, ventricular tachycardia on anti-arrhythmia are excluded; 1st degree AV block or asymptomatic LAFB/RBBB will not be excluded), or
    c.Congestive heart failure of NYHA Class ≥3, or
    d.Myocardial infarction within 3 months
    17.Females who are pregnant or actively breastfeeding.
    18.Uncontrolled (ie, clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.
    19.Active hepatitis C and/or B infection.
    20.Patients unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI dysfunction that could interfere with absorption of study treatment. A history of bowel obstruction requiring a nasogastric tube or intravenous infusion during the past 2 months is not allowed (except when this obstruction is caused by surgery or other non-malignant causes).
    21.Psychiatric illness or substance use that would prevent the patient from giving informed consent or being compliant with the study procedures.
    22.Patients unwilling or unable to comply with the protocol.
    23.Persons who have been committed to an institution by official or judicial order.
    24.Patients with dependency on the Sponsor, Investigator or study site.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is Progression Free Survival (PFS), which is defined as the time from randomization until documented progressive disease or death due to any cause, whichever occurs first. For the primary analysis of the primary endpoint, documented progressive disease will be determined by the Investigator using RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after Last Patient In
    E.5.2Secondary end point(s)
    •PFS, as assessed by a BICR, per RECIST v1.1
    •Time to first subsequent therapy (TFST) and time to second subsequent treatment (TSST).
    •Progression-free survival (PFS2)
    •Disease-specific survival (DSS) and overall survival (OS)
    •Disease-control rate (DCR; defined as best response of CR, PR, or SD for at least 16 weeks).
    •European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-EN24.
    •The safety and tolerability of study treatment will be evaluated based on AE reports, physical examination results (including vital signs), and clinical laboratory results by means of the occurrence, nature and severity of AEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months afer Last Patient Last Visit
    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 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) 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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Belgium
    Canada
    Czech Republic
    Germany
    Israel
    Italy
    Poland
    Spain
    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
    End of study will be 12 months after the last enrolled patient, when the last patient in the study has withdrawn consent, has been withdrawn from the study by the Investigator, has died, or has been lost to follow-up, whichever occurs first
    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: 132
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 60
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 192
    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)
    After the trial, the patients will receive the standard of care follow-up and/or treatment of this condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation MITO (Multicenter Italian trials in Ovarian Cancer)
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation GEICO (Grupo Español de Investigación de Cáncer de
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation NOGGO (North-Eastern-German Society of
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation CEEGOG
    G.4.3.4Network Country Czech Republic
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation UZLEUVEN/BGOG
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
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