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    Summary
    EudraCT Number:2014-001434-29
    Sponsor's Protocol Code Number:VX-EC-2-2013
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-26
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2014-001434-29
    A.3Full title of the trial
    A Phase II Study of Sodium Cridanimod in Conjunction with Progestin Therapy in Patients with Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma.
    Štúdia fázy II kridanimodu sodného v spojení s progestínovou liečbou u pacientok negatívnych na receptor progesterónu s rekurentným alebo pretrvávajúcim karcinómom endometria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study of Sodium Cridanimod in Conjunction with Hormonal Therapy in Patients with Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma.
    Klinická štúdia kridanimodu sodného v spojení s progestínovou liečbou u pacientok negatívnych na receptor progesterónu s rekurentným alebo pretrvávajúcim karcinómom endometria
    A.4.1Sponsor's protocol code numberVX-EC-2-2013
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02064725
    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 SponsorAS Kevelt
    B.1.3.4CountryEstonia
    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 supportAS Kevelt
    B.4.2CountryEstonia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccord Research s.r.o.
    B.5.2Functional name of contact pointLibor Gajda
    B.5.3 Address:
    B.5.3.1Street AddressU Mlýna 1797/1
    B.5.3.2Town/ cityPrague 4
    B.5.3.3Post code141 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number00420725 428 160
    B.5.5Fax number00420222 318 403
    B.5.6E-mailLibor.Gajda@accordresearch.eu
    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 nameSodium Cridanimod
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium 2-(9-oxoacridin-10-yl)acetate
    D.3.9.3Other descriptive nameOxodihydroacridinylacetate sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    PrR negative papillary serous adenocarcinoma, endometroid type of endometrial carcinoma
    E.1.1.1Medical condition in easily understood language
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10014743
    E.1.2Term Endometrial carcinoma
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10014747
    E.1.2Term Endometrial carcinoma 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 17.0
    E.1.2Level PT
    E.1.2Classification code 10033700
    E.1.2Term Papillary serous endometrial carcinoma
    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 assess antitumor activity of sodium cridanimod in conjunction with progestin therapy as measured by objective response rate (partial and complete) in women with progestin receptor (PrR) negative recurrent or persistent endometrial carcinoma not amenable to treat with surgery, radiotherapy, chemotherapy.
    E.2.2Secondary objectives of the trial
    - Efficacy: To assess progression free survival, time to response, time to progression, duration of overall survival and overall Disease Control Rate for patients receiving sodium cridanimod and progestin therapy.
    - Safety: To evaluate the safety and tolerability of sodium cridanimod in conjunction with progestin therapy as measured by adverse events, laboratory safety parameters and electrocardiac safety assessments (including QT prolongation potential).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients age 18 and older;
    2. Histologically confirmed papillary serous adenocarcinoma or endometroid type of endometrial carcinoma (histological documentation of recurrence is not required);
    3. Patient has documented evidence of PrR negative endometrial cancer. PrR negativity can be determined by immunohistochemistry. The tumor is considered PrR negative if the number of PrR positive cells is less than 1% determined by immunohistochemistry;
    4. Availability of tumor tissue sample that can be used for assessment of PrR levels with the use of immunohistochemistry;
    5. Recurrent or persistent (after the failure of chemotherapy) disease that cannot be treated with surgery or radiotherapy;
    6. Documented disease progression after a platinum based chemotherapy in patients for whom administration of taxanes and anthracyclines is not planned. Progression must fulfill one of the following criteria:
    - Progression has occurred within 30 days of platinum based chemotherapy consisting of minimum of two cycles of cisplatin-based (≥60 mg/m2/cycle) or carboplatin-based (≥300 mg/m2/cycle, or area under the time-concentration curve ≥4) chemotherapy.
    - Progression after neoadjuvant or adjuvant platinum based chemotherapy if the recurrence occurred while on neoadjuvant/adjuvant chemotherapy or within 6 months since the last administration of such therapy.
    7. Measurable disease as defined by RECIST 1.1 criteria;
    8. At least one "target lesion" to be used to assess response, as defined by RECIST 1.1 criteria;
    9. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented;
    10. GOG performance status 0-2 (see Appendix A);
    11. Glomerular filtration rate ≥ 50 mL/min;
    12. Total bilirubin normal;
    13. AST ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastases);
    14. Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases);
    15. Albumin ≥ 3.0 mg/dL;
    16. Ability to take oral medication;
    17. Ability to understand and the willingness to sign a written informed consent document.
    E.4Principal exclusion criteria
    1. Evidence of histology of the tumor other than papillary serous adenocarcinoma or endometroid type of endometrial carcinoma or mixed histology of the tumor;
    2. History of hormonal therapy for endometrial carcinoma for more than 3 months;
    3. History of use of progestins for a period of longer than 3 months for any indication, including endometriosis;
    4. Concurrent maintenance corticosteroids;
    5. Concurrent oral contraceptives/ Fertile patients must use effective barrier contraception;
    6. Pregnancy as determined by pregnancy test or nursing;
    7. History of bleeding (i.e. disseminated intravascular coagulation or clotting factor deficiency);
    8. Prior major surgery less than 4 weeks prior to the start of the study;
    9. Concurrent serious illness which, in the opinion of the investigator, would place the patient at unreasonable risk from study therapy;
    10. Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin;
    11. History of allergic reactions or idiosyncrasy attributed to progestins or compounds of similar chemical structure to sodium cridanimod or lidocaine;
    12. Known brain metastases;
    13. Other concurrent investigational agents;
    14. Other concurrent anticancer therapies.
    15. Known carrier of HIV.
    16. Participation in any clinical study within 4 weeks prior to the planned administration of the drug.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (CR and PR) as defined by RECIST 1.1 criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    as defined by RECIST 1.1 criteria
    E.5.2Secondary end point(s)
    Progression-Free Survival (PFS).
    Time to response
    Duration of overall response
    Duration of stable disease
    Overall survival.
    Overall Disease Control Rate
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression-Free Survival (PFS). The PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
    Time to response (The duration of time from start of treatment to CR or PR).
    Duration of overall response (Defined in protocol appendix B).
    Duration of stable disease (Defined in protocol appendix B).
    Overall survival. Overall survival is defined as the period from registration onto the study until the patient’s death on any cause or the patient was last contacted.
    Overall Disease Control Rate (Rate of patients that achieved complete response, partial response and stable disease as defined in protocol appendix B).
    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) 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.8.3 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 EEA8
    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
    Belarus
    Czech Republic
    Estonia
    Russian Federation
    Slovakia
    Ukraine
    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 years3
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 15
    F.4.2.2In the whole clinical trial 58
    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 Decision2014-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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