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    Summary
    EudraCT Number:2009-013665-26
    Sponsor's Protocol Code Number:CLDE225B2204
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-013665-26
    A.3Full title of the trial
    A double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the efficacy, safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on superficial and nodular sporadic skin basal cell carcinomas
    A.4.1Sponsor's protocol code numberCLDE225B2204
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.3.2Product code LDE225
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLDE225
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    sporadic superficial skin basal cell carcinomas
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10042503
    E.1.2Term Superficial basal cell carcinoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the safety and local tolerability of topically applied 0.75% LDE225
    cream during and after 6 weeks treatment of superficial basal cell carcinomas
    (sBCCs) and perilesional uninvolved skin.
    • To assess the efficacy (clinical evaluation) of topically applied 0.75% LDE225 cream
    in the treatment of sBCCs during and after the 6 week treatment period.
    E.2.2Secondary objectives of the trial
    • To evaluate the pharmacodynamic effect (histological signs of tumor regression;
    apoptosis, tumor proliferation markers) in sBCCs after treatment with topically applied 0.75% LDE225 cream.
    • To investigate the effect of topically applied 0.75% LDE225 cream on specific
    biomarkers related to the Smo pathway (Gli1, Gli2, Ptch1 and Ptch2) in sBCC tumor
    tissue.
    • To assess the LDE225 pharmacokinetics in plasma after multiple applications of 0.75% LDE225 cream onto the skin.
    • To evaluate the LDE225 concentration in perilesional uninvolved skin and involved skin (sBCCs) after multiple applications of 0.75% LDE225 cream onto the skin.
    • In addition exploratory objectives are also conducted these involve digital photography, immunohistochemistry, pharmacogenomics and pharmacogenetics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female (non-childbearing potential) patients, ages 18 to 75 years (inclusive), with one histologically confirmed superficial or nodular basal cell carcinoma (diameter 8-20 mm), eligible for surgical excision on selected body areas (scalp, arm, frontal trunk, posterior trunk, upper legs), will be included. (Note: Presence of other non-melanoma skin cancers at sites distant from the qualifying sBCC will not a priori exclude the patient from the study).
    2. Physical examination must be without significant disease findings (other than sBCC or nBCC) unless the Investigator considers an abnormality to be irrelevant to the outcome of the study.
    3. At Screening, day 1, 15 and Safety Visit, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the patient has rested for at least three (3) minutes and again when required after three (3) minutes in the standing position. Vital signs should be within the following ranges:
    - oral body temperature between 35.0-37.5 C
    - systolic blood pressure, 90-150 mm Hg
    - diastolic blood pressure, 50-95 mm Hg
    - pulse rate, 40 - 90 bpm
    If vital signs are out-of-range, see protocol for further advice and action.
    4. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of > 40 IU/L at screening. Female patients who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures (tubal ligation is not considered adequate) should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
    5. Male patients must be using two highly effective methods of contraception (comprising a barrier method such as condom or occlusive cap plus spermicide) plus ensure use by the female partner of a second method of contraception. These measures should be in place for the entire duration of the study to the Study Completion visit, males should refrain from fathering a child in the three (3) months following the last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.
    6. Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 29 kg/m2. See Appendix 3 of this protocol for BMI ranges.
    7. Able to communicate well with the Investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    E.4Principal exclusion criteria
    1. Previous treatment of the BCC that is selected for treatment.
    2. Use of any topical treatment whether prescribed or as on OTC on the treated areas during the course of the study.
    3. Any systemic treatment which is known to affect BCC especially cytostatic treatments, retinoids and photodynamic treatments.
    4. Treatment with any systemic immunomodulating drugs or systemic retinoid 4 weeks prior to initial dosing.
    5. Treatment with imiquimod within 4 weeks prior to initial dosing.
    6. Women of child-bearing potential; nursing or pregnant women.
    7. Dark-skinned persons whose skin color prevents readily assessment of skin reactions (patients with skin phototype IV or higher (Fitzpatrick classification of Skin Phototypes (I-VI) (Pathak and Fitzpatrick 1993) will be excluded.
    8. Use of prescription drugs (excluding those mentioned in exclusion criteria no. 2, 3, 4, and 5) are permitted and must be recorded on the Concomitant medications page of the eCRF.
    9. Use of any topical creams or lotions on the treated area during the course of the study.
    10. A history of, or suffering from, any skin condition in the area of application.
    11. Tattoos, scars or excess hair in the area of application that will prevent skin assessment.
    12. A history of keloid scars.
    13. Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    14. Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
    15. Significant illness within two (2) weeks prior to initial dosing.
    16. A past medical history of clinically significant ECG abnormalities.
    17. An abnormal ECG (defined as PR > 220 msec, QRS complex > 120 msec, QTcB > 430 msec females; QTcB > 420 msec males, or any significant morphological changes, other than non-specific T-wave changes).
    18. Recent (within the last three [3] years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
    19. History of multiple and recurring allergies or allergy to the investigational
    compound/compound class being used in this study.
    20. Laboratory safety tests outside the reference range and deemed clinically significant.
    21. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
    22. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    23. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
    24. Total WBC count which falls outside the range of 4000–10,000/μL, or platelets
    <150,000/μL at screening.
    25. Patients who are exposed to UV radiation and/or tanning beds within 2 weeks before screening and during treatment.
    26. Patients with history of allergy or intolerance to local anesthetics and or epinephrine to be used for skin surgical procedures.
    E.5 End points
    E.5.1Primary end point(s)
    see main objective section
    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 No
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    local tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    vehicle-controlled
    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
    vehicle-controlled
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 48
    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 Decision2009-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-05-10
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