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    Summary
    EudraCT Number:2007-002093-60
    Sponsor's Protocol Code Number:BCX1777-203
    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:2008-02-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-002093-60
    A.3Full title of the trial
    Single agent phase II study of Forodesine (BCX1777) in the treatment of cutaneous T-Cell Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    forodesine in CTCL
    A.4.1Sponsor's protocol code numberBCX1777-203
    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 SponsorBioCryst 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/3/06/428
    D.3 Description of the IMP
    D.3.1Product nameForodesine hydrochloride
    D.3.2Product code BCX1777
    D.3.4Pharmaceutical form Capsule*
    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.3.9.2Current sponsor codeBCX1777
    D.3.9.3Other descriptive nameforodesine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    Primary cutaneous T-cell lymphomas (CTCLs)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028508
    E.1.2Term Mycosis fungoides/Sezary syndrome
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL, stages IIb, III and IVa.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:

    1. To assess the safety and tolerability of daily administration of oral forodesine in this population;
    2. To determine the time to objective response in subjects with CTCL having cutaneous manifestations of the disease;
    3. To determine the duration of objective response in subjects with CTCL having cutaneous manifestations of the disease;
    4. To determine the loss of objective response;
    5. To determine the objective response rate of extracutaneous manifestations of CTCL (lymph node enlargement, Sezary cells in peripheral blood).
    6. To determine the time to objective response and duration of objective response of extracutaneous manifestations of CTCL in subjects who have extracutaneous manifestations of disease; and,
    7. To determine subjects' assessments of treatment-related changes in health related quality of life (HRQoL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or non-pregnant females aged ≥18 years;
    2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or sezary syndrome;
    3. Subjects with CTCL stages IB, IIA, IIB, III or IVA who have persistent, progressive, or recurrent disease during or following treatment with at least three forms of systemic therapy, one of which must have been bexarotene, unless treatment with oral bexarotene was not tolerated or was medically contraindicated;
    4. Anticipated life expectancy > 6 months;
    5. Performance status of 0, 1, or 2 by ECOG;
    6. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of study treatment ;
    7. Females of child bearing potential and sexually active males, if indicated, must be willing and able to use method(s) of contraception that are adequate to prevent or minimize the risk of pregnancy for the duration of the study; and,
    8. Written informed consent to participate in the study.
    E.4Principal exclusion criteria
    CTCL-related Exclusion Criteria

    1. Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB) (note: presence of lymphadenopathy is permitted);
    2. Previous treatment with forodesine;
    3. ECOG performance status >2;
    4. Concomitant use of any anti-cancer therapy or immune modifier;
    5. Concomitant use of any investigational agent or device;
    6. Concurrent treatment with any other anti-CTCL therapy, or radiation therapy. Topical corticosteroids (except classes 1 and 2 which are prohibited) or low dose oral corticosteroids (≤10 mg/day prednisone or equivalent) will not be excluded, but if used, must be a stable dose and schedule during the four weeks immediately prior to study entry;
    7. Use of previous therapies for CTCL within the timeframes specified below:
    a. Phototherapy in the previous 30 days;
    b. Electron beam therapy, photopheresis, systemic anticancer therapy, interferon therapy, or other investigational therapy in the previous 30 days;
    c. Oral retinoid (including bexarotene) in the previous 30 days;
    d. Alemtuzumab (Campath) or other monoclonal antibody within the previous 30 days
    e. Vorinostat or other HDAC inhibitor within previous 30 days
    f. Any investigational therapy within the previous 30 days;

    Hepatic/Renal/Metaboli Exclusion Criteria

    8. ALT or AST >3 times ULN or alkaline phosphatase >2 times ULN;
    9. Calculated creatine clearance ≤50mL/min or serum creatine ≥1.8mg/dL;
    10. Serum potassium <3.3mg/dL or >5.5mg/dL;
    11. Evidence of clinically significant (uncontrolled) hypo- or hyperthyroidism;

    Cardiovascular Exclusion Criteria

    12. Recent (in past 6 months) medically significant cardiac event (i.e., myocardial infarction, cardiac surgery);
    13. Presence of congestive heart failure (NYHA class IV) or angina (NYHA class IV) or presence of a medically significant dysrhythmia;
    14. Presence of any of the following ECG findings:
    a. Congenital long QT syndrome;
    b. QTc interval >480 msec (Bazett’s correction);
    15. Presence of uncontrolled hypertension manifested by systolic blood pressure ≥160mmHg and or diastolic blood pressure ≥90mmHg;

    Hematologic Exclusion Criteria

    16. Hemoglobin <9.0gm/dL (intermittent red blood cell transfusions permitted);
    17. Absolute neutrophil count <1500cells/mm^3;
    18. Platelet count <75,000/mm^3;
    19. Requirement for neutrophil or platelet growth factor therapy or administration of such therapy in the previous 30 days;
    20. CD4 count <200/mm^3

    Infection-Related Exclusion Criteria

    21. Documented current active infection with HIV, Hepatitis B, Hepatitis C and/or CMV;
    22. Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy); or,
    23. History of culture-documented bacteremia in the previous 2 weeks.

    General Exclusion Criteria

    24. Recent (i.e., in past 2 weeks) change in doses or regimens of medications used for any chronic non-oncologic condition for reasons of worsening of the chronic illness (change in doses of chronic medications associated with improvement in a chronic illness are not exclusionary);
    25. Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled;
    26. coexistent second malignancy or history of prior malignancy within 5 years [excluding basal cell or squamous cell carcinoma of skin and cervical neoplasia (carcinoma in situ) that has been treated curatively]. Surgically resected nonmelanomatous skin cancer (non-CTCL) with no evidence of recurrence in 6 months is permitted; and,
    27. Any significant medical or psychiatric condition that in the opinion of the investigator, might prevent the subject from complying with all required study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is an assessment of objective response (OR) for each patient, defined as either complete cutaneous response (CR) or partial cutaneous response (PR), in subjects with CTCL Stages IIB, III, or IVA. Cutaneous response will be determined by use of a modified severity weighted assessment tool (mSWAT). Objective response will be defined as either no evidence of clinical disease or a marked improvement that is ≥50% decrease in mSWAT score compared to Baseline. Confirmation of objective response will be required by a second assessment after at least 28 days. At the time of confirmation of OR, CT scans (neck, chest, abdomen and pelvis) should be performed to confirm the absence of progression of any pre-existing lymph node disease involvement.
    Cutaneous disease manifestations will be documented by serial standardised body photgraphy and skin assessment worksheets.
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    The end of the trial will be after the last enrolled patient has been treated for 6 months. Access to forodesine will continue to be provided for those patients who are deriving benefit and who are not adversely affected by side effects.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 150
    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 Decision2008-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
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