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    The EU Clinical Trials Register currently displays   44209   clinical trials with a EudraCT protocol, of which   7332   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002093-60
    Sponsor's Protocol Code Number:BCX-1777 203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-14
    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 ConcernedItaly - Italian Medicines Agency
    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 numberBCX-1777 203
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 Kingdom
    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 Information not present in EudraCT
    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
    D.3.2Product code BCX-1777
    D.3.4Pharmaceutical form Capsule, hard
    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 codeBCX-1777
    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 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
    Primary Cutaneous T-cell Lymphomas (CTCL)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028483
    E.1.2Term Mycosis fungoides
    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 repsonse 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
    1. Assess the safety and tolerability of daily administration of oral forodesine in this population 2. Determine the time to objective repsonse in subjects with CTCL having cutaneous manifestations of the disease 3. Determine the duration of objective repsonse in subjects with CTCL haing cutaneous manifestations of the disease 4. Determine the loss of objective response 5. Determine the objective response rate of extracutaneous manifestations of CTCL (lymph node enlargment, Sezary cells in peripheral blood) 6. Determine the time to objective response and duration of objective response of extracutaneous manifestations of CTCL in subjects who have extracutaneous manifestations of disease 7 Determine subjects assessment of treatment related changes in health related quality of life (HRQoL).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Males and non-pregnant femails aged &#8805; 18 years 2. Histologically confirmed diagnbosis 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 treament with at least three forms of systemic therpay one of which must have been bexarotene, unless treatment with oral bexarotene was not tolerated or was medically contraindicated 4. Anitipated life expectancy > 6 months 5. Performance status of 0,1 or 2 by ECOG 6. Females of child bearing potential must have a negative serum prenancy test within 14 days prior to intiation 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 mimimize the risk of pregnancy for the duration of the study 8. Written informed consent to participate in the study
    E.4Principal exclusion criteria
    CTCL related 1. Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVb)prescence of lymphadenopathy is permitted 2. Previous treatment with forodesine 3. ECOG performance status >2 4. Concomitant use of any anti-cancer therpay or immune modifer 5 Concomitant use of any investigational agent or device 6. Concomitant treatment with any other anti-CTCL therapy or radiation therapy. Topical corticosteriods (except clases 1 and 2 which are prohibited) or low dose oral corticosteriods (&#8804;10 mg/day prednisone or equivalent) will not be excluded, but if used must be a stable dose and schedle during the four weeks immediately prior to the study entry 7. Use of previous therapies for CTCL withi the previous 30 days: a)Phototherapy b. electron beam therapy, photophoresis, systemic anticancer therpay, interferon therapy, or other investigational therapy c. oral retinoid (including bexarotene) d. Alemtuzumab (Campath) or other monoclonal antibody e. Vorinostat or other HDAC inhibitor f. any investigational therapy Hepatic/Renal/ Metabolic EXcl Criteria 8. ALT or AST > 3 times ULN or alkaline phosphatase >2 times ULN 9. Calculated creatinine clearance &#8804;50ml/min or serum creatine &#8805;1.8 mg/dl 10 Serum potassium <3.3mg/dl or >5.5 mg/dl 11. Evidence of clinically significant (uncontrolled) hypo or hyperthyroidism CArdiovascular criteria 12. REcent(in the past 6 months) medically significant cardiac event 13. Prescence of congestive heart failure (NYHA IV) or angina (NYHA class IV) or prescence of a medically significant dysrhythmia 14. Prescence of the following ECG findings a. Congenital long QT syndrome; b. QTc interval >480 msec (Bazett’s correction); 14. Presence of uncontrolled hypertension manifested by systolic blood pressure &#8805;160 mmHg and/or diastolic blood pressure &#8805;90 mmHg; Hematologic Exclusion Criteria 15. Hemoglobin <9.0 gm/dL (intermittent red blood cell transfusions permitted); 16. Absolute neutrophil count <1500 cells/mm3; 17. Platelet count <75,000/mm3; 18. Requirement for neutrophil or platelet growth factor therapy or administration of such therapy in the previous 30 days; 19. CD4 count <200/mm3; Infection-Related Exclusion Criteria 20. Documented current active infection with HIV, Hepatitis B, Hepatitis C, and/or CMV; 21. Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy); or, 22. History of culture-documented bacteremia in the previous 2 weeks. General Exclusion Criteria 23. 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); 24. Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled; 25. Coexistent second malignancy or history of prior malignancy within previous 5 years [excluding basal cell or squamous cell carcinoma of skin and cervical neoplasia (carcinoma-insitu) that has been treated curatively]. Surgically resected nonmelanomatous skin cancer (non-CTCL) with no evidence of recurrence in previous 6 months is permitted; and, 26. 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 endoint 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 IIB, III or IVa.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 No
    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) 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.8.5The 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 Information not present in EudraCT
    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
    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 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 months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-01-14. Yes
    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 state10
    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 Decision2008-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
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