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    Summary
    EudraCT Number:2009-014699-24
    Sponsor's Protocol Code Number:4SC-201-2-2009
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-26
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-014699-24
    A.3Full title of the trial
    A Phase 2 Proof of Concept Study to Evaluate the Efficacy, Safety and Pharmacokinetics of the HDAC Inhibitor 4SC-201 in Patients with Relapsed or Refractory Hodgkin’s Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    SAPHIRE
    A.4.1Sponsor's protocol code number4SC-201-2-2009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsor4SC AG
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 name4SC-201
    D.3.2Product code 4SC-201
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNto be proposed
    D.3.9.1CAS number 864814-88-0
    D.3.9.2Current sponsor code4SC-201
    D.3.9.3Other descriptive nameBYK408740
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typehistone diacetylase (HDAC) inhibitor
    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
    Relapsed or refractory Hodgkin’s lymphoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to determine the best overall objective response rate (ORR) based on IWG criteria (20) of 4SC-201 in patients with refractory or relapsed HL
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are:
    • to investigate the safety and tolerability of repeated oral doses of 4SC-201
    • to assess overall survival (OS) in patients treated with repeated oral doses of 4SC-201
    • to determine progression free survival (PFS) in patients treated with repeated oral doses of 4SC-201, including radiological and symptomatic progression
    • to determine time to progression (TTP) in patients treated with repeated oral doses of 4SC-201 including objective and symptomatic progression
    • to determine duration of response (DOR) in patients treated with repeated oral doses of 4SC-201
    • to assess the pharmacokinetics of 4SC-201 after oral dosing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Patients must have histological or cytological evidence of Hodgkin’s lymphoma (all subtypes are acceptable).
     Patients must have relapsed HL after second or subsequent-line therapy or have a refractory disease defined as non-CR after or PD during first-line therapy and PD following second-line (salvage) therapy. Patients may have also undergone high-dose chemotherapy with autologous stem cell transplantation at least 12 weeks prior to study entry.
     Patients must have measurable anatomical disease present on CT scan
     Patients must be > 18 years of age
     Patients must have an ECOG Performance Score of 0, 1 or 2 (Appendix A)
     Patients must have a life expectancy of at least 12 weeks
     Patients or their legal representatives must be able to comprehend and provide written informed consent
     Patients must have adequate bone marrow reserve as evidenced by:
     Absolute neutrophil count (ANC) > 1,500/µl
     Platelet count > 75,000/µl
     Patients must have adequate renal function as evidenced by a serum creatinine <2.0 mg/dl
     Patients must have adequate hepatic function as evidenced by a serum bilirubin < 2.0 mg/dl and serum asparatate aminotransferase (AST) and alanine aminotransferase (ALT) levels < 3X the ULN for the reference lab (< 5X the ULN if there is known to be hepatic involvement by HL)
     Patients must be fully recovered from the effects of any prior therapy for HL.
     Women of childbearing potential must have a negative urine or serum pregnancy test (a women is considered to be NOT of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for 12 consecutive months)
     Women of childbearing potential as well as fertile men and their partners must agree to either abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method, such as condom and diaphragm)
     Men with partners of childbearing potential are requested to use barrier contraception in addition to having their partner use another method of contraception during the trial and until at least 3 months following the last administration of the study medication. Male patients will also be advised to abstain from sexual intercourse with pregnant or lactating women, or to use condoms.
    E.4Principal exclusion criteria
     Patients who have received previous treatment with an HDAC inhibitor
     Patients who have undergone allogeneic hematopoietic stem cell transplantation
     Patients with known or suspected involvement of the CNS by HL
     Any gastrointestinal disorder that could interfere with the absorption of 4SC-201, such as active ulcerative colitis, Crohn’s disease, diabetic gastroparesis, or other syndromes characterized by malabsorption
     Therapy with agents known to prolong the QT interval (Appendix E)
     Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA < 0.1 ng/ml; or cervical intraepithelial neoplasia.
     Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure (NYHA Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months.
     Patients with any other medical, psychiatric or social condition, which in the opinion of the investigator would preclude participation in the trial, pose an undue medical hazard, interfere with the conduct of the trial or interfere with interpretation of the trial results
     Patients with a history of hypersensitivity reactions to any of the components of 4SC-201
     Women who are pregnant or lactating or who are planning on becoming pregnant during the trial or for 90 days after completion of the trial
     Patients who have received an investigational therapy within 4 weeks of signing the informed consent for the current study
     Patients with a confirmed QTcF > 450 msec
     Patients with a history of, who were treated for, or who are suspected of having, hepatitis B, hepatitis C or HIV. Patients suspected of having any of these conditions should undergo appropriate evaluations prior to being enrolled in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The objective response rate (ORR) will be defined as the best response over the course of a patient’s participation in the trial. For the purposes of this trial, objective response will be a complete response or partial response based on anatomical imaging according to the International Working Group (IWG) criteria, or stable anatomical disease with improvement in functional (PET) imaging. The ORR and the exact 95% confidence interval will be presented. The ORR will be evaluated on the efficacy population.
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The trial will conclude when the last patient remaining in the study completes 12 months of therapy, expires, develops progressive neoplastic disease, or discontinues treatment for any other reason.
    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 months8
    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 months8
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with malignancy
    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 45
    F.4.2.2In the whole clinical trial 45
    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)
    Standard treatment for the later stages of Hodgkin's lymphoma does not exist. For patients still benefiting from investigational treatment at the time point of the study completion, continuation of the treatment will be ensured by the Sponsor
    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 Decision2009-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-14
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