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    Summary
    EudraCT Number:2012-000677-23
    Sponsor's Protocol Code Number:CLCL161A2201
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-000677-23
    A.3Full title of the trial
    A Phase II, multi-center, open-label, neoadjuvant, randomized study of weekly paclitaxel with or without LCL161 in patients with triple negative breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, phase 2, neoadjuvant study of weekly paclitaxel with
    LCL161 in patients with triple negative breast cancer
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberCLCL161A2201
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41613241111
    B.5.5Fax number+41613248001
    B.5.6E-mailclinicaltrial.enquiries@novartis.com
    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 LCL161
    D.3.4Pharmaceutical form Tablet
    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 codeLCL161
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Triple negative breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer,
    analyzed separately in the gene expression signature negative and
    positive groups.
    E.2.2Secondary objectives of the trial
    1. To characterize the safety and tolerability of the LCL161/paclitaxel
    combination compared to weekly paclitaxel alone.
    2. To evaluate whether combination treatment with LCL161 and
    paclitaxel is associated with increased apoptosis compared to weekly
    paclitaxel alone.
    3. To evaluate the PK of LCL161 when given in combination with
    Paclitaxel
    4. To assess other indicators of disease response for the LCL161 +
    Paclitaxel combination compared to paclitaxel alone.
    5. To assess whether adding LCL161 to weekly paclitaxel enhances the
    efficacy of paclitaxel in women with triple negative breast cancer
    regardless of tumor gene expression signature status
    6. To assess whether use of the gene expression signature identifies
    tumors more likely to respond to treatment with LCL161 and paclitaxel
    7. To assess whether the gene expression signature is correlated with
    response to single agent paclitaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of invasive triple negative breast cancer.
    - Known status for the LCL161 predictive gene expression signature as
    determined during molecular pre-screening.
    - Candidates for mastectomy or breast-conserving surgery.
    - Primary tumor of greater than 20 mm and less than 50 mm diameter measured by imaging.
    - Regional nodes NO-N2
    - Absence of distant metastatic disease.
    - ECOG performance status 0-1.
    - Adequate bone marrow function.
    - Adequate liver function and serum transaminases.
    - Adequate renal function.
    E.4Principal exclusion criteria
    - Bilateral or inflammatory breast cancer (bilateral mammography is
    required during Screening/baseline), locally recurrent breast cancer.
    - Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months.
    - Uncontrolled cardiac disease.
    - Patients who are currently receiving chronic treatment (more than 3
    months) with corticosteroids at a dose ≥ 10 mg of prednisone (or its
    glucocorticoid equivalent) per day (inhaled and topical steroids are
    allowed), or any other chronic immunosuppressive treatment that
    cannot be discontinued prior to starting study drug.
    - Impaired GI function that may affect the absorption of LCL161.
    - Pregnant or breast feeding (lactating) women.
    - Women of child-bearing potential, defined as all women physiologically
    capable of becoming pregnant, unless they are using highly effective
    methods of contraception during dosing and for at least 180 days after
    study treatment.
    - Other protocol-defined inclusion/exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    - Pathological complete response (pCR) rate in breast after 12 weeks of
    therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    1. Frequency of adverse events, serious adverse events and clinical
    laboratory abnormalities
    2. Caspase 3 activation in tumor by IHC
    3. PK parameters including Area under Curve (AUC)
    4.
    - Rates of breast conserving surgery and mastectomy
    - pCR rate in breast, regional nodes and axilla
    5. pCR rate in breast after 12 weeks of therapy - full study population
    6. pCR rate after treatment with LCL161 + Paclitaxel
    7. pCR rate in breast after 12 weeks of therapy with gene signature + or
    - treated with paclitaxel alone
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 18 weeks
    2. 12 weeks
    3. pre-dose, 0.5, 1, 2, 4 hours post-dose
    4.
    - 16 weeks
    - 12 weeks
    5. 12 weeks
    6. 12 weeks
    7. 12 weeks
    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 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) 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 Yes
    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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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 EEA24
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Czech Republic
    France
    Germany
    Ireland
    Italy
    Korea, Republic of
    Russian Federation
    Spain
    Turkey
    United Kingdom
    United States
    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
    The end of the study for each patient will occur approximately 45 days
    after the last administration of study medication (LCL161 or
    paclitaxel), and the study will be completed after the last patient
    treated completes the 45 days follow-up.
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 200
    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 Decision2013-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
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