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    Summary
    EudraCT Number:2013-003668-30
    Sponsor's Protocol Code Number:KCP-330-004
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-10-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003668-30
    A.3Full title of the trial
    A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients with Recurrent Gliomas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients with Recurrent Gliomas
    A.3.2Name or abbreviated title of the trial where available
    KING
    A.4.1Sponsor's protocol code numberKCP-330-004
    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 Therapeutic, 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 organisationKaryopharm Therapeutic, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address85 Wells Ave, 2nd floor
    B.5.3.2Town/ cityNewton
    B.5.3.3Post codeMA 02459
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617658 0600
    B.5.6E-mailclinicaltrials@karyopharm.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 nameSelective Inhibitor of Nuclear Export (SINE)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent glioblastoma or other brain cancer after failure of radiation therapy and temozolomide
    E.1.1.1Medical condition in easily understood language
    Recurrent glioblastoma or other brain 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 10002224
    E.1.2Term Anaplastic astrocytoma
    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 10073128
    E.1.2Term Anaplastic oligodendroglioma
    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 10018337
    E.1.2Term Glioblastoma multiforme
    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 10018336
    E.1.2Term Glioblastoma
    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 10027769
    E.1.2Term Mixed oligo-astrocytoma
    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 10026659
    E.1.2Term Malignant oligodendroglioma
    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 determine the efficacy of Selinexor in adults with recurrent GBM as determined by the 6-months progression-free survival (6mPFS) rate
    E.2.2Secondary objectives of the trial
    • To determine the efficacy of Selinexor in adults with recurrent GBM as determined by response rate according to the RANO criteria
    • To determine the efficacy of Selinexor in adults with recurrent GBM as estimated by median overall survival (OS)
    • To determine the efficacy of Selinexor in adults with recurrent GBM as determined by median progression-free survival (PFS)
    • To evaluate safety and tolerability of Selinexor
    • To determine tumor concentration of Selinexor and molecular effects during treatment
    • To evaluate preliminary evidence of efficacy of Selinexor in a small group of patients undergoing cytoreductive surgery (Arm A)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pathologically confirmed diagnosis of GBM (including all histologic variants) with radiographic evidence of recurrent disease after treatment with radiotherapy and temozolomide;
    2. Age ≥ 18 years;
    3. Karnofsky Performance Status (KPS) ≥ 60;
    4. Patients enrolling in the medical arm (Arms B, C, or D) must be on a stable or decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline CT/MRI;
    5. Patients must have received prior treatment with radiation therapy and temozolomide (all arms);
    6. Measurable disease (according to RANO guidelines, within 14 days of starting treatment). Measurable disease after surgery on arm A is not required.
    7. Written informed consent obtained prior to any screening procedures. Patients must be willing and able to comply with the protocol and aware of the investigational nature of this study.
    8. Patients must have adequate bone marrow function and organ function within 2 weeks of study treatment as defined by the following laboratory criteria;
    o Hematopoietic function: total white blood cell count (WBC) ≥ 3000/mm³, absolute neutrophil count (ANC) ≥ 1500/mm³, platelet count ≥ 125,000/mm³; hemoglobin ≥ 9g/dL
    o Hepatic function: bilirubin < 1.5 times the upper limit of normal (ULN), ALT < 2.0 times ULN, AST < 2.0 times ULN; unless bilirubin elevation is related to Gilbert’s Syndrome for which bilirubin must be <4 times ULN.
    o Renal function: estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockroft and Gault or other standard methods at the treating institution..
    9. All female patients of childbearing potential must agree to use reliable methods of birth control during study treatment and for 3 months after the last dose of study drug and have a negative serum pregnancy test at Screening. Reliable methods of contraception include intrauterine devices, hormonal contraceptives [contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release], abstinence or sterilization of the partner;
    10. Fertile males must be willing to employ reliable methods of contraception during study treatment and for 3 months after the last dose of study drug.
    11. Archived paraffin-embedded tissue: approximately 10 unstained slides (if less, contact Sponsor) or a tumor block must be available for correlative studies.
    12. Patients in the Surgical Arm (Arm A) must be predicted pre-operatively to have sufficiently sized tumor to be resected and provide tissue samples for exploratory assessments.
    13. Patients enrolling in the medical arm (Arms B, C, or D) must have an interval of at least 12 weeks from completion of radiation therapy and study unless there is histologic proof of active tumor from intervening resection.
    E.4Principal exclusion criteria
    1. Patients must not have significant medical illness that in the Investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy.
    2. <24 days from prior temozolomide, <6 weeks from nitrosourea, <4 weeks from other chemotherapy or investigational agents prior to start of treatment within study.
    3. Unstable cardiovascular function.
    4. Known active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); hepatitis testing is not required.
    5. Known HIV infection; HIV testing is not required.
    6. Markedly decreased visual acuity if attributed to other causes than GBM.
    7. Active infection requiring parenteral systemic antibiotics.
    8. Patients with coagulation problems and medically significant bleeding in the month prior to start of treatment (e.g., peptic ulcer, epistaxis, spontaneous bleeding). Prior history of DVT or PE is not exclusionary.
    9. Patients who are pregnant or breast-feeding.
    10. Other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.
    11. Patients must not have significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications.
    12. Dehydration of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 1.
    13. Patients must not have serious psychiatric or medical conditions that could interfere with treatment.
    14. History of organ allograft.
    15. Concurrent therapy with approved or investigational anticancer therapeutics.
    16. Prior treatment with bevacizumab or other direct VEGF/ VEGFR inhibitors. For any question of the definition of a direct VEGF/VEGFR consult Sponsor.
    17. Arms C and D only: Body Surface area < 1.2 m2, to avoid a dose exceeding the maximum allowable dose of 70 mg/m2.
    18. Major surgery < 4 weeks prior to the start of study treatment.
    E.5 End points
    E.5.1Primary end point(s)
    • 6-months Progression-free survival (6mPFS) rate (Progression of disease defined according to the RANO criteria)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after start of treatment within the study
    E.5.2Secondary end point(s)
    1 Response rate according to the RANO criteria
    2 Median progression-free survival (PFS)
    3 Median overall survival (OS)
    4 Safety
    5 Tumor concentration of Selinexor
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Assessment of disease status every 8 weeks from start of therapy within study
    2. From Start of therapy within study to occurrence of disease progression
    3. At the time of death of patients
    4. From Start of therapy within study to End of treatment visit
    5. At the time of surgery in Arm A (Day 3 or 8)
    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) 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) 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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Denmark
    Netherlands
    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
    End of study will be when the last patient has died or all patients have completed EOT and have been followed for at least 6 months after their first dose of study drug, or have been lost to follow-up, or withdrew consent, 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 110
    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 completion of the End of Treatment visit, patients will generally be treated at the discretion of the investigator according to standard medical routine.
    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 Decision2015-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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
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