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    Summary
    EudraCT Number:2018-003190-96
    Sponsor's Protocol Code Number:SHR-3680-III-HSPC
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-04
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-003190-96
    A.3Full title of the trial
    One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load
    Multicentrické, randomizované, otevřené klinické hodnocení fáze III
    porovnávající přípravek SHR3680 v kombinaci s androgen deprivační
    terapií (ADT) oproti bikalutamidu v kombinaci s ADT při léčbě
    metastazujícího hormonálně senzitivního karcinomu prostaty s vysokou
    nádorovou zátěží
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of prostate cancer
    A.4.1Sponsor's protocol code numberSHR-3680-III-HSPC
    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 SponsorJiangsu Hengrui Pharmaceuticals Co., Ltd.
    B.1.3.4CountryChina
    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 supportJiangsu Hengrui Pharmaceuticals Co., Ltd.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJiangsu Hengrui Pharmaceuticals Co., Ltd.
    B.5.2Functional name of contact pointFrank Becker
    B.5.3 Address:
    B.5.3.1Street AddressNo. 7 Kunlunshan Road
    B.5.3.2Town/ cityLianyungang
    B.5.3.3Post code222047
    B.5.3.4CountryChina
    B.5.4Telephone number+41 79 735 5315
    B.5.6E-mailfrank.becker@hengrui.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 nameSHR3680
    D.3.2Product code SHR3680
    D.3.4Pharmaceutical form 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 INNn/a
    D.3.9.1CAS number 1572045-62-5
    D.3.9.2Current sponsor codeSHR3680
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Casodex®
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBicalutamide
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Film-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 INNBicalutamide
    D.3.9.1CAS number 90357-06-5
    D.3.9.2Current sponsor codeBicalutamide
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Metastatic hormone-sensitive prostate cancer with high tumor load
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10071119
    E.1.2Term Hormone-dependent prostate cancer
    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 whether SHR3680 combined with ADT is superior to Bicalutamide combined with ADT in improvement of rPFS and OS in subjects with high tumor load mHSPC.
    E.2.2Secondary objectives of the trial
    - To evaluate and compare the time to PSA progression, time to the next bone related event, time to the start of the next anti-prostate cancer therapy and objective response rate in the subjects with high tumor load mHSPC who were treated with SHR3680 combined with ADT versus Bicalutamide combined with ADT
    - To evaluate and compare the safety of SHR3680 combined with ADT versus Bicalutamide combined with ADT in treatment of subjects with high tumor-load mHSPC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≧18 years, male;
    - Performance status ECOG scores 0-1;
    - Histologically or cytologically confirmed adenocarcinoma of the prostate, and no neuroendocrine differentiation or small cell features;
    - High tumor load, i.e., the radiological examination meets at least one of the following conditions: 1) ≧4 bone metastatic foci are found in Tc-99m bone scan (at least one focus not in pelvis or spine); 2) visceral metastasis is shown in CT/MRI (not including lymph node);
    - Plan to receive or maintain ADT in study period, i.e., continuous use of luteinizing hormone releasing hormone analogue (LHRHA) (drug castration) or previous bilateral orchidectomy (surgical castration);
    - Being unable to tolerate or not willing to receive chemotherapy;
    - The organ function level must meet the following requirements:
    ANC≧1.5×109/L;
    PLT≧100×109/L;
    Hb≧90 g/L;
    TBIL≦1.5×ULN;
    ALT and AST ≦2.5 × ULN;
    BUN(or UREC) and Cr≦1.5×ULN;
    LVEF≧50%.
    - Ability to comply with the study protocol as judged by the investigator;
    - Being voluntary to participate in this clinical trial, understanding the study procedure and being able to sign the written informed consent.
    E.4Principal exclusion criteria
    - Previous ADT, chemotherapy, surgery, external irradiation, brachytherapy, radiopharmaceutical or investigational local therapy (e.g., radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.) for prostate cancer
    - Previous use or plan to use the second generation androgen receptor antagonist (e.g., enzalutamide, ARN-509, ODM-201), ketoconazole, Abiraterone Acetate or other drugs medicines uder development inhibiting synethsis of androgen (e.g., TAK-700) for treatment of prostate cancer during study treatment;
    - Having received the following therapies within 4 weeks prior to C1D1:
     5α-reductase inhibitor (e.g., Finasteride, dutasteride);
     Estrogen, Progesterones, androgen, systemic steroids (except temporary use for anti-allergic purpuse);
     Plant medicine with known anti-prostate cancer or PSA-lowering effect (e.g., Saw Palmetto);
     Other study treatment in clinical trials.
    - Presence of radiologically confirmed central nervous system lesions;
    - Plan to receive any other antitumor therapies during this trial;
    - History of known allergy to the components of SHR3680 tablet or Bicalutamide tablet;
    - Inability to swallow, chronic diarrhea and intestinal obstruction, presence of multiple factors affecting drug intake and absorption;
    - History of epilepsy, or diseases that can induce epileptic seizure within 12 months prior to C1D1 (including history of transient ischemic attack, cerebral stroke, brain trauma with disturbance of consciousness requiring hospitalization);
    - Presence of active heart diseases within 6 months prior to C1D1, including severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug therapy;
    - Any other malignant tumor within 5 years prior to C1D1 (except carcinoma in situ that has been completely relieved and the malignant tumor that is judged by investigators as slowly progressive);
    - Active HBV, HCV infection (HBV virus≧104copies/mL, HCVviru ≧103copies/mL);
    - History of immunodeficiency (including positive HIV test, or having other acquired or congenital immunodeficiency disease) or history of organ transplantation;
    - Unwillingness to take effective contraceptive measures throughout the study treatment period and within 30 days after the last dose;
    - Presence of concomitant diseases (e.g., poorly controlled hypertension, serious diabetes, neurological or psychological disorders, etc.) or any other conditions that seriously endanger patient’s safety, may confuse the study results or affect completion of the study, according to investigator’s judgement.
    E.5 End points
    E.5.1Primary end point(s)
    rPFS, OS
    E.5.1.1Timepoint(s) of evaluation of this end point
    When 282 events of radiological progression of disease occur, the primary endpoint rPFS will be analyzed. When 195 events of death occur, the interim analysis of the primary endpoint OS will be performed. When 325 events of death occur, the final analysis of the primary endpoint OS will be performed.
    E.5.2Secondary end point(s)
    - Time to PSA progression
    - Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bone)
    - Time to the start of the next anti-prostate cancer therapy
    - Objective response rate
    - Safety endpoint
    E.5.2.1Timepoint(s) of evaluation of this end point
    - PSA evaluation: it will be performed within 7 days prior to the first dose, on Day 1 of each cycle from Cycle 2-12, once every two cycles from Cycle 13-36, once every 4 cycles afterwards; the first progression of PSA needs to be confirmed ≧3 weeks later
    - Objective response rate: CT/MRI at baseline. If the evaluation first reaches the criteria of CR or PR, subjects must receive repeated test for confirmation 4 weeks after the first evaluation.
    - Bone related event, next anti-prostate cancer therapy, safety: throughout the study
    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 No
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    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 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 EEA18
    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
    China
    Bulgaria
    Czechia
    Poland
    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
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 342
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 572
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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