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    Summary
    EudraCT Number:2004-003701-24
    Sponsor's Protocol Code Number:21011
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-003701-24
    A.3Full title of the trial
    A randomised, open-label phase III trial to evaluate the efficacy and safety of Bexarotene (TargretinTM) capsules combined with PUVA, compared to PUVA treatment alone in patients with Mycosis Fungoides.
    A.4.1Sponsor's protocol code number21011
    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 SponsorEuropean Organisation for Research and Treatment of Cancer (EORTC)
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Bexarotene (TargretinTM)
    D.2.1.1.2Name of the Marketing Authorisation holderLigand Pharmaceuticals
    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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBexarotene (TargretinTM)
    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.3.11 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 Information not present in EudraCT
    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
    Patients suffering from histopathologically documented Mycosis Fungoides, clinical stage Ib-IIa
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028500
    E.1.2Term Mycosis fungoides NOS
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To adress whether adding Bexarotene (TargretinTM) to the standard PUVA treatment for patients with stage Ib and IIa Mycosis Fungoides could decrease the cumulative dose of UVA needed to achieve a complete clinical response. The primary objective will therefore be to compare the cumulative dose of UVA required to achieve a CCR in both treatment arms.
    E.2.2Secondary objectives of the trial
    Safety data, overall response rates and the duration of response will also be compared.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histopathologically documented Mycosis Fungoides, clinical stage Ib-IIa confirmed by current or previous diagnostic lesion biopsy
    -A Karnofsky performance ≥ 60
    -Age >18 years
    -Acceptable organ function defined as follows:
    -Hemoglobin ≥ 9 g/dl and WBC ≥ 2 x 1000000000/l
    -Bilirubin ≤ 1.5 times the upper limit of normal for the institution
    -Creatinine ≤ 2 times the upper limit of normal for the institution
    -SGOT (AST) and SGPT (ALT) ≤ 2.5 times the upper limit of normal for the institution
    -Serum calcium between LNN for the institution and ≤ 2.8 mmol/l or 11.5 mg/dl
    -Fasting serum triglycerides within normal limits for the institution (patients with serum triglycerides that are “normalized” prior to study entry with use of an antilidemic agent may be enrolled)
    -No evidence of severe cardiac insufficiency, (NYHA grade III-IV)
    -Women of child bearing potential must have a negative serum pregnancy test (β-HCG) within 7 days prior to randomization
    -Female patients and male patients with female partners of child bearing potential must agree to practice an effective contraception during the entire period of treatment and for at least 3 months after treatment is discontinued. Female patients with child bearing potential must agree to use a reliable form of contraception. A non-hormonal treatment of contraception is also necessary for women using hormonal contraception methods. Male patients with female sexual partners who are pregnant or potentially pregnant must agree to use condoms during sexual intercourse during the entire period of treatment and for at least 3 months after treatment is discontinued
    -No other prior or concurrent primary malignant tumor (except adequately treated in situ carcinoma of the cervix or basal or squamous cell skin carcinoma)
    -No prior systemic combination chemotherapy
    -TSEB (Total Body Electron Beam) therapy should not have been given less than 6 months before entry into the trial
    -Topical chemotherapy, photophoresis and interferon should not have been given less than 3 months before entry into the trial
    -No topical medications (corticosteroids or tar baths), UVB/PUVA phototerapy, superficial radiotherapy, treatment with any other retinoid class drugs or beta-carotene compounds within 1 month before entry into the trial
    -Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment
    -Patients must be willing and able to prolonged exposure to the sun. Patients must be willing to accept limited sun exposure on the day receiving PUVA treatment
    -Absence of intrinsic (lupus) or extrinsic (photosensitive drugs) photosensitivity
    -Patients must not have participated in any other investigational drug study within 30 days before entry into the trial, or have taken part in any other study of Bexaroten (TargretinTM) capsules
    -Absence of any psyciological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    -Before patient randomization written informed consent must be given according to ICH/GCP and national/local regulations
    E.4Principal exclusion criteria
    -Lactating women
    -Patients who were intolerant or unresponsive to prior PUVA therapy will be excluded
    -Patients with known contradiction to Bexarotene (TargretinTM) therapy: known hypersensitivity to retinoids, hypervitaminosis A, patients with prior pancreatitis, excessive alcohol consumption, patients taking drugs associated with pancreatic toxicity or known to increase triglyceride concentrations, patients with uncontrolled diabetes mellitus, uncontrolled thyroid disease
    E.5 End points
    E.5.1Primary end point(s)
    The cumulative dose of UVA necessary to achieve a complete clinical response in both treatment arms (Arm 1: Liquid Psoralen with UVA irradiation (PUVA). Arm 2: Bexarotene (TargretinTM) and PUVA).
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    PUVA treatment compared to PUVA treatment combined with Bexarotene (TargretinTM) treatment
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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 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 trial will end with the last visit of the last subject undergoing this trial.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 134
    F.4.2.2In the whole clinical trial 134
    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)
    The patients will receive the expected normal treatment of Mycosis Fungoides after ending their participation
    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 Decision2007-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-31
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