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    Summary
    EudraCT Number:2014-000428-12
    Sponsor's Protocol Code Number:CLEE011X2201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-01-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-000428-12
    A.3Full title of the trial
    A randomized, blinded, placebo-controlled, phase II trial of LEE011 in patients with relapsed, refractory, incurable teratoma with recent progression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for patients with relapsed, refractory, incurable teratoma with recent progression. The study is randomized (the patient may receive the investigational drug or placebo) and it is blinded (the patient and the study doctor will not know what drug the patient receives).
    A.4.1Sponsor's protocol code numberCLEE011X2201
    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 S.A.S.
    B.5.2Functional name of contact pointInformation&Communication Médicale
    B.5.3 Address:
    B.5.3.1Street Address2-4 rue Lionel Terray
    B.5.3.2Town/ cityRueil-Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155476600
    B.5.5Fax number+33155476100
    B.5.6E-mailicm.phfr@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 LEE011
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 codeLEE011
    D.3.9.3Other descriptive nameLEE011
    D.3.9.4EV Substance CodeSUB31644
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsed, refractory, incurable teratoma
    E.1.1.1Medical condition in easily understood language
    relapsed, refractory, incurable teratoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory teratoma with recent progression
    E.2.2Secondary objectives of the trial
    1.To assess other measures of efficacy of LEE011 compared with placebo
    2.To assess safety and tolerability of LEE011 compared with placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥ 15 years old at time of informed consent.
    2.Diagnosis of teratoma for which no additional standard surgical or medical therapy exists
    3.Availability of an archival tumor biopsy specimen (collected at diagnosis or progression) with accompanying pathology report
    •Patients without an archival tumor sample may be permitted to participate after discussion between Novartis and the investigator
    4.Patients must have completed at least 1 prior line of chemotherapy for germ cell tumor
    5.If malignant transformation is present then chemotherapy appropriate for malignant transformation histology must have been given
    6. Radiographic progression, defined by RECIST v.1.1, after the last cancer treatment and within 12 weeks prior to enrollment, compared with scans within 1 year of enrollment.
    7.Measurable or evaluable extra-cranial disease as defined by RECIST v.1.1
    8.Patients must have ECOG performance status of 0-1

    Other criteria may apply.
    E.4Principal exclusion criteria
    1.CNS disease unless radiation therapy and/or surgery has been completed and serial evaluation by CT (with contrast enhancement) or MRI over a minimum of 3 months demonstrates stable disease. Patient must be asymptomatic and without need for treatment with systemic corticosteroids or anti-epileptic medications
    2.Malignant germ cell tumors other than that being treated in this study, including tumors with elements of mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or seminoma
    3.Concurrent malignancy other than teratoma or malignancy within 3 years of randomization, with the exception of adequately treated basal or squamous cell carcinoma of the skin, curatively resected cervical cancer or curatively resected carcinoma in situ of any type
    4.Prior treatment with any CDK4/6 inhibitor therapy
    5.Any concurrent severe and/or uncontrolled medical condition that, in the investigator’s judgment serves as a contraindication to patient participation (e.g., chronic pancreatitis, active hepatitis, viral hepatitis or known HIV positivity. Baseline HIV screening is not required
    6.Patients who have not recovered to ≤ CTCAE grade 1 from the acute toxic effects (except for alopecia) of all prior chemotherapy, immunotherapy, or radiotherapy
    7.Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
    8.Impaired cardiac function or any clinically significant cardiac disease, including any of the following
    •Left ventricular ejection fraction (LVEF) < 45% or less than the institution’s lower limit of normal as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO)
    •Congenital long QT syndrome or family history of unexpected sudden cardiac death
    •QT corrected with Fredericia’s (QTcF) QTcF >450 msec for males and >470 msec for females on screening ECG
    •Clinically significant heart disease such as CHF requiring treatment (NYH grade ≥ 2), unstable angina pectoris or myocardial infarction within the past 3 months. Any other clinically significant heart disease such as unstable arrhythmia, resting bradycardia, right bundle branch block, bifascicular block, or any heart disease that requires the use of a cardiac pacemaker ≤ 3 months prior to starting study drug
    •Patients who are currently receiving medications with known risk of prolonging the QT interval or inducing Torsades de Pointes and are unable to discontinue or switch to an alternate medication
    9.Concomitant therapy that precludes enrollment
    •Systemic antineoplastic therapy or any experimental therapy within 3 weeks before the first dose of study drug (6 weeks for prior nitrosoureas, bevacizumab, or mitomycin C)
    •Systemic corticosteroids within 2 weeks prior to starting study drug. Note: Corticosteroids are permitted for use as single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
    10.Major surgery within 2 weeks prior to planned start of study drug or patient has not recovered from major side effects of the surgery
    11.Received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, or patient has not recovered to ≤ CTCAE grade 1 related toxicity
    12.Requirement for treatment with any of the prohibited medications including strong CYP3A inhibitors, strong CYP3A inducers, CYP3A substrates with a narrow therapeutic index, and medications with strong risk of QT prolongation
    13.Have any of the following out-of-range laboratory values
    •Absolute neutrophil count < 1.5× 10^9/L
    •Platelet count < 100 × 10^9/L
    •Hemoglobin <9.0 g/dL
    •Potassium unless correctable by oral supplementation
    •Calcium (corrected for serum albumin) unless correctable by oral supplementation
    •Magnesium within normal limits for the institution unless correctable by oral supplementation
    •Serum creatinine ≥1.5 × ULN
    •Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) > 3 × ULN for age; for patients with liver metastases ≥ 5 × ULN for age.
    •Total serum bilirubin >1.5 x ULN; or total bilirubin ≥3.0 × ULN with direct bilirubin within normal range in patients with well documented Gilbert’s Syndrome
    •INR ≥1.5

    other criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) as per RECIST v1.1 (by local investigator assessment)
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Evaluated after at least 25 and approximately 62 PFS events have been documented for the interim analysis and primary CSR, respectively.
    E.5.2Secondary end point(s)
    1. Best Overall Response (BOR),Overall response rate (ORR) and Disease Control Rate (DCR) as per RECIST v1.1, Overall Survival (OS) and OS rate

    2. Incidence and severity of adverse events and serious adverse events, changes in laboratory values, and electrocardiograms will be used to assess the safety as per CTCAE v.4.03. Dose interruptions and changes will be used to assess the tolerability.

    E.5.2.1Timepoint(s) of evaluation of this end point
    -All secondary endpoints will be evaluated after at least 25 and approximately 62 PFS events have been documented for the interim analysis and primary CSR, respectively.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 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
    France
    Netherlands
    Spain
    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 study data will be analyzed and a primary clinical study report will be written based on all patients’ data at the time when there are approx. 62 PFS events for the primary efficacy analysis, or if the study is terminated early. Additional data for patients continuing on study or in survival follow-up past the data cutoff date for the primary CSR will be reported in a final CSR once the treatment period, safety follow-up, disease follow-up and survival follow-ups have ended for all patients
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) No
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 90
    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)
    none
    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 Decision2014-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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