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    Summary
    EudraCT Number:2004-001012-32
    Sponsor's Protocol Code Number:GPI-04-0001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-001012-32
    A.3Full title of the trial
    A single agent Phase II study of depsipeptide (FK228) in the treatment of Cutaneous T-cell lymphoma
    A.3.2Name or abbreviated title of the trial where available
    Depsipeptide in CTCL
    A.4.1Sponsor's protocol code numberGPI-04-0001
    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 SponsorGloucester Pharmaceuticals 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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/279
    D.3 Description of the IMP
    D.3.1Product nameDepsipeptide
    D.3.2Product code FK228
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet given
    D.3.9.2Current sponsor codeFK228
    D.3.9.3Other descriptive nameDepsipeptide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.02 0.10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Cutaneous T-cell lymphoma (CTCL),
    (peripheral T-cell lymphoma unspecified NOS)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the efficacy of FK228, depsipeptide, as reported in the Phase I and early Phase II studies, in patients with CTCL who are no longer controlled on skin directed therapy and who have had at least one prior systemic therapy. The rate of objective disease response, as determined by the Objective Primary Disease Response Evaluation Criteria (OPDREC), will be used as the primary endpoint to assess efficacy.
    E.2.2Secondary objectives of the trial
    • To evaluate the rate of objective disease control.
    • To evaluate duration of objective disease response, and time to objective disease progression.
    • To evaluate the safety of depsipeptide in terms of adverse events, clinical laboratory data, physical examinations, ECG findings, rate of neutropenic fever and sepsis, blood transfusions, and treatment compliance.
    • To evaluate the pharmacokinetics of depsipeptide in a cohort of patients with CTCL
    • To evaluate disease status with molecular markers in PBMCs and potentially tumours, including acetylation status, apoptosis markers, STAT, AKT and caspases.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Males or non-pregnant females aged >/=18 years.
    • Histologically confirmed diagnosis of CTCL, including mycosis fungoides and Sézary syndrome.
    • Patients with CTCL stages IIa, IIb, III and IVa
    • Patients with CTCL stage Ib who have relapsed following previous therapy and where, in the investigator’s opinion, the potential benefit of treatment with FK228 outweighs the possible risks.
    • Patients who have failed standard skin-directed therapy and have had at least one course of systemic therapy, such as interferon, which they have been deemed to have failed.
    • Anticipated life expectancy greater than six months.
    • Written informed consent to participate in the study.
    E.4Principal exclusion criteria
    • ECOG Performance Status > 1 (see Appendix H).
    • Patients who have not received at least 1 course of prior systemic therapy for CTCL.
    • Visceral involvement i.e. Stage 4b disease (lymphadenopathy is allowed).
    • Patients with known cardiac abnormalities such as:-
    Congenital long QT syndrome
    QTc interval > 480 milliseconds
    Any cardiac arrhythmia requiring anti-arrhythmic medication.
    • Patients who have had a myocardial infarction within 12 months of study entry.
    • Patients who have a history of coronary artery disease (CAD) e.g. angina Canadian class II to IV (Appendix N). In any patient in whom there is doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.
    • Patients with an ECG recorded at screening showing evidence of cardiac ischaemia (ST depression of 2 mm). If in any doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.
    • Patients with congestive heart failure that meets New York Heart Association class II to IV definitions (Appendix O) and/or ejection fraction <40% by multiple gated acquisition (MUGA) scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI)
    • Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest, unless currently addressed with an automatic implantable cardioverter defibrillator (AICD).
    • Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above).
    • Patients with uncontrolled hypertension, i.e. 160/95 mmHg.
    • Concomitant use of any anti-cancer therapy. (For study eligibility, a one month washout period is required before treatment with depsipeptide is started for patients who have received radiotherapy or psoralen plus ultraviolet A (PUVA) therapy.)
    • Concomitant use of warfarin.
    • Concomitant use of any investigational agent.
    • Use of any investigational agent within 4 weeks before treatment with depsipeptide is started.
    • Concomitant use of drugs which may cause a prolongation of the QTc interval. (For study eligibility, a washout period of at least 5 half-lives must elapse before treatment with depsipeptide is started. A list of half lives is provided in Appendix F.)
    • Patients with a potassium level of <3.5 mmol/L and a magnesium level of <0.8 mmol/L.
    • Clinically significant active infection.
    • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
    • Inadequate bone marrow or other organ function, as evidenced by:
    o unsupported haemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted);
    o absolute neutrophil count (ANC) </=1.5 x 109/L;
    o platelet count <100 x 109/L;
    o total bilirubin >1.25 x upper limit of normal (ULN) for institution;
    o aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN, serum creatinine >2 x ULN for age and sex.
    • Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin or cervical epithelial neoplasm [CIN1, carcinoma in situ] that has been treated curatively).
    • Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
    • Patients who are pregnant or breast-feeding. All women of child bearing potential must use an effective method of contraception (either an intrauterine device or a double barrier method using condoms or a diaphragm plus spermicide) during the study and for at least 1 month after receiving the last dose of depsipeptide. Male patients must use a barrier method of contraception (condoms) during the treatment period and for at least 1 month thereafter. Hormonal methods of contraception such as the contraceptive pill or patch (particularly those containing ethinyl-estradiol) should be avoided due to a potential drug interaction (see Appendix L).
    • Use of topical steroids in the previous 2 weeks or systemic steroids in the previous 4 weeks before treatment with depsipeptide is started.
    • Having previously given consent to participate in this study.
    • Concomitant use of CYP3A4 inhibitors (see Appendix L).
    E.5 End points
    E.5.1Primary end point(s)
    The rate of objective disease control as defined as confirmed complete response (CR), complete clinical response (CCR), partial response (PR), or stable disease (SD, for SD with a duration of at least 3 months) as determined by the Objective Primary Disease Response Evaluation Criteria (OPDREC)
    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 Information not present in EudraCT
    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 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) 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    4 weeks after the last application of FK228 (last visit)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 90
    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)
    6 cycles (6 months) are possible in this study protocol, with an option (in responding patients) to continue until disease progression.
    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 Decision2006-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
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