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    The EU Clinical Trials Register currently displays   40109   clinical trials with a EudraCT protocol, of which   6567   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-016083-36
    Sponsor's Protocol Code Number:CS7017-A-U204
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-016083-36
    A.3Full title of the trial
    Phase 2 Study of CS-7017 and Erlotinib in Subjects with Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to help test a study drug called CS-7017 in combination with chemotherapy in patients that have non-small cell lung cancer
    A.4.1Sponsor's protocol code numberCS7017-A-U204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01101334
    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 SponsorDaiichi Sankyo Pharma Development
    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 supportDaiichi Sankyo Pharma Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross
    B.5.3.3Post codeSL90BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441753482800
    B.5.5Fax number+441753899107
    B.5.6E-mailinfo@dsd-eu.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 CS-7017
    D.3.4Pharmaceutical form Film-coated 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.3.9.1CAS number 1048002-36-3
    D.3.9.2Current sponsor codeCS-7017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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
    Treatment of patients with advanced non-small cell lung cancer (NSCLC) after failure of prior chemotherapy regimen
    E.1.1.1Medical condition in easily understood language
    Cancer of the colon and rectum (colorectal cancer) can invade and damage tissues and organs. Tumors of the colon/ rectum are growths of the inner wall of the large intestine.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    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
    To estimate the difference in efficacy, as measured by progression-free survival (PFS), between erlotinib in combination with CS-7017 and erlotinib alone.
    E.2.2Secondary objectives of the trial
    To estimate the overall survival (OS) in the two treatment arms.

    To estimate the overall response rate (ORR) in the two treatment arms.

    To estimate plasma concentration of CS-7017 at scheduled times points.

    To evaluate the safety profile of the combination of CS-7017 and erlotinib relative to that of erlotinib alone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy all of the following criteria to be included in the study:
    1. Histologically or cytologically confirmed stage IIIB or IV NSCLC previously treated with a platinum-based regimen.
    2. Progressive disease (either no response to treatment or subsequent relapse after an objective response) after the last anti-cancer therapy.
    3. Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.
    4. ≥ 18 years of age
    5. ECOG performance status of 0, 1, or 2.
    6. Adequate organ and bone marrow function as assessed by clinical laboratory evaluations:
    - Hemoglobin ≥ 9 g/L
    - Absolute neutrophil count ≥ 1.5 x 10e9/L
    - Platelets ≥ 100 x 10e9 /L
    - Serum creatinine <1.5 upper limit of normal (ULN) or calculated
    creatinine clearance > 60 mL/min
    - Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase < 2.5 x ULN if liver metastases are absent or ≤ 5.0 x ULN if liver metastases are present
    - Total bilirubin ≤1.5 x ULN
    7. Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade ≤ 1 (see Section 17.2).
    8. Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. Men who are the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.
    9. All female subjects of childbearing potential must have a negative serum or urine pregnancy test result before initiating study treatment.
    10. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC- or IRB-approved ICF (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests.
    11. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will be disqualified from entering the study:
    1. More than two prior chemotherapy regimens for advanced disease. Maintenance
    therapy does not count as a separate regimen, if it is given after first line therapy
    without intervening disease progression.
    2. Prior treatment with EGFR inhibitors.
    3. Treatment with anticancer therapy within 3 weeks before study treatment.
    4. Therapeutic or palliative radiation therapy within 2 weeks or major surgery within
    4 weeks before study treatment.
    5. Prior administration of other TZDs within 4 weeks before study treatment or current need for concomitant use of other TZDs during the study.
    6. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms; uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Subjects with treated brain metastases which are no longer symptomatic and require no treatment may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 15 days must have elapsed between the end of radiotherapy and study enrollment.
    7. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening.
    8. History of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
    9. Pericardial effusion or pericardial involvement with the tumor. Clinically significant pleural effusion (ie, requiring drainage). Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
    10. History of malignancy other than NCSLC, except adequately treated
    non melanoma skin cancer, curatively treated in-situ cancer of the cervix or other
    solid tumors curatively treated with no evidence of disease for ≥ 5 years.
    11. Previous administration of CS-7017.
    12. Pregnant or breast feeding.
    13. Serious intercurrent medical or psychiatric illnesses or any other conditions that in
    the opinion of the Investigator would impair the ability to give informed consent
    or unacceptably reduce protocol compliance or safety of the study treatment.
    14. Known hypersensitivity to any of the two study drugs.
    15. Subjects currently enrolled in another investigational drug study or within
    4 weeks of start of treatment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For progression free survival, we will evaluate whole Kaplan-Meier curve over time, not Kaplan-Meier curve at some specific timepoint.
    E.5.2Secondary end point(s)
    The secondary endpoints are OS, ORR, safety endpoints of adverse events (AEs), clinical laboratory evaluations, physical examination findings, and vital sign measurements, and plasma concentrations of CS-7017.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For overall survival, we will evaluate whole Kaplan-Meier curve over time, not Kaplan-Meier curve at some specific timepoint.
    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 Yes
    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 No
    E.8.1.4Double blind No
    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
    Active-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
    The MP Erlotinib alone, without CS-7017
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Germany
    India
    Korea, Republic of
    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
    As per protocol
    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 months0
    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 months0
    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.1.3Elderly (>=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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    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)
    As per protocol.
    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 Decision2010-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-23
    The status of studies in GB is no longer updated from 1.1.2021
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