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    Summary
    EudraCT Number:2013-004812-24
    Sponsor's Protocol Code Number:INCB39110-203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-09-03
    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 number2013-004812-24
    A.3Full title of the trial
    A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non–Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of INCB039110 in combination with docetaxel in advanced Non–Small Cell Lung Cancer
    A.3.2Name or abbreviated title of the trial where available
    INCB39110 with docetaxel in NSCLC
    A.4.1Sponsor's protocol code numberINCB39110-203
    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 SponsorIncyte Corporation
    B.1.3.4CountryUnited States
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressRt 141 & Henry Clay Road
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19880
    B.5.3.4CountryUnited States
    B.5.4Telephone number18554633463
    B.5.5Fax number13024252734
    B.5.6E-mailRegAffairs@incyte.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 INCB039110
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeINCB039110
    D.3.9.3Other descriptive nameINCB039110
    D.3.9.4EV Substance CodeSUB167037
    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) 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 placeboTablet
    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
    Male or female, 18 years or older with histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
    E.1.1.1Medical condition in easily understood language
    Adults with advanced NSCLC
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety Run-In Phase (Part 1):
    • To evaluate the safety and tolerability of INCB039110 in combination with docetaxel and select their doses for further evaluation.
    Randomized Phase (Part 2):
    • To evaluate and compare the OS of subjects with previously treated advanced or metastatic NSCLC when treated with INCB039110 in combination with docetaxel versus docetaxel alone.
    E.2.2Secondary objectives of the trial
    •To evaluate and compare the efficacy of the 2 treatment groups with respect to PFS.
    •To evaluate and compare the efficacy of the 2 treatment groups with respect to overall tumor response and duration of response.
    •To evaluate and compare disease control of INCB039110 in combination with docetaxel versus INCB039110 alone.
    •To evaluate and compare the safety and tolerability of INCB039110 in combination with docetaxel versus docetaxel alone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male or female, 18 years or older.
    •Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV or recurrent.
    •mGPS of 1 or 2 as defined below:
    •mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L
    •mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L.
    •Radiographically measurable or evaluable disease.
    •Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease (not including neoadjuvant and/or adjuvant therapy except as noted below).
    •Prior systemic regimens must include a platinum based therapy. Investigational agents used in combination with standard platinum therapies are allowed.
    •Tumors with driver mutations (EGFR mutation positive or ALK fusion oncogene positive) are allowed provided they also had prior treatment with a tyrosine kinase inhibitor (TKI).
    •Maintenance therapy after first-line chemotherapy is allowed provided that the maintenance therapy did not include docetaxel or other taxane.
    •Subjects who completed a platinum-containing regimen as adjuvant, neoadjuvant, or part of a course of chemoradiation therapy within the 6 months before screening are allowed.
    •Prior treatment of advanced or metastatic disease with immune targeted therapy is allowed.
    •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
    E.4Principal exclusion criteria
    •Received prior treatment with a taxane.
    •Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 3 months prior to study entry, defined as:
    -No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
    -Asymptomatic and off all corticosteroids and anticonvulsants for at least 3 months prior to study entry.
    •≥ Grade 3 peripheral neuropathy.
    •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy.
    •Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.
    If the subject has any of the following, they are excluded.
    •Absolute neutrophil count < 1.5 × 109/L.
    •Platelet count < 100 × 109/L.
    •Hemoglobin < 9 g/dL (transfusion are permitted to achieve baseline hemoglobin level.)
    •ALT/AST > 2.5 × the upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
    •Alkaline phosphatase >2.5 x ULN.
    • Subjects with ALT or AST elevation > ULN AND alkaline phosphatase > ULN.
    •Total bilirubin > ULN.
    •Creatinine clearance <50 mL/min measured or calculated by Cockroft-Gault equation or glomerular filtration rate (GFR) < 50 mL/min/1.73 m2 as calculated using modification of diet in renal disease (MDRD).
    •Currently receiving therapy with a potent CYP3A4 inducer or inhibitor. Subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin therapy after 1 week or 5 half-lives, whichever is longer.
    •Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive malignancy.
    E.5 End points
    E.5.1Primary end point(s)
    Safety run-in Phase (Part 1)
    •Safety and tolerability of the treatment regimens through assessment of AEs and changes in safety assessments including laboratory parameters.
    •Determination of a MTD of INCB039110 in combination with docetaxel.

    Randomized Phase (Part 2)
    •Overall survival determined from the date of randomization until death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is OS, defined as number of days from randomization to death.
    Once a total of 69 events has been observed, which is expected after an enrollment period of 12 months, and 5 months of follow-up after the last subject is randomized.

    E.5.2Secondary end point(s)
    •Progression-free survival defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause, if sooner.
    •Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment.
    •Safety and tolerability through assessment of AEs and changes in safety assessments and laboratory parameters.
    •Disease control as measured by the percentage of patients whose best response was not progressive disease (PD) (ie, complete response [CR], partial response [PR], or stable disease [SD] per RECIST v1.1). Stable disease will be included if it occurs at least 6 weeks after randomization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy analysis will be conducted for the intent-to-treat population.
    Progression-free survival will be determined from the randomization date until the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause if earlier.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned7
    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
    Australia
    Canada
    Hong Kong
    Korea, Republic of
    United States
    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
    Each subject enrolled in the study will continue receiving study treatment in until disease progression, when the treatment phase will end and the subject will enter the follow-up phase (30-35 days after last dose)
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 172
    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 Decision2014-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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