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    The EU Clinical Trials Register currently displays   35918   clinical trials with a EudraCT protocol, of which   5893   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-007107-32
    Sponsor's Protocol Code Number:M10-301
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-03
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2007-007107-32
    A.3Full title of the trial
    A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin /Paclitaxel in Combination with ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
    A.4.1Sponsor's protocol code numberM10-301
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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.3.1Product nameABT-869
    D.3.2Product code ABT-869, A-741439.0
    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.3.9.1CAS number 796967-16-3
    D.3.9.2Current sponsor codeABT-869, A-741439.0
    D.3.9.3Other descriptive name1-[4-(3-Amino-1H-indazol-4-yl)phenyl]-3 -(2-fluoro-5-methylphenyl)urea
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 2
    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.3.1Product nameABT-869
    D.3.2Product code ABT-869, A-741439.0
    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.3.9.1CAS number 796967-16-3
    D.3.9.2Current sponsor codeABT-869, A-741439.0
    D.3.9.3Other descriptive name1-[4-(3-Amino-1H-indazol-4-yl)phenyl]-3 -(2-fluoro-5-methylphenyl)urea
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Non small cell lung cancer.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029514
    E.1.2Term Non-small cell lung cancer NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029516
    E.1.2Term Non-small cell lung cancer stage 0
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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 if the addition of oral ABT-869 to carboplatin and paclitaxel can prolong progression-free survival (PFS) compared to carboplatin and paclitaxel alone in subjects with NSCLC.
    E.2.2Secondary objectives of the trial
    To evaluate overall survival and other efficacy endpoints as well as the safety and tolerability of each of the treatment arms. To evaluate Quality of Life (QoL), performance status and body weight.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    At selected clinical study sites, an optional pharmacogenetic sample collection will be performed. For subjects who have signed the appropriate Informed Consent Form, DNA samples from this protocol may be used to assess the influence of genetic variants on pharmacokinetics, safety or efficacy. For example, polymorphisms in genes encode drug metabolizing enzymes (such as cytochrome P450s or uridine
    glucuronosyltransferases) or drug transport proteins (such as ATP-binding cassette or solute-linked carrier proteins) may be assessed for their influence on ABT-869
    pharmacokinetics. Genetic variants of potential ABT-869 targets (such as VEGF or PDGF RTKs) may also be assessed.
    E.3Principal inclusion criteria
    1. The subject must be ≥ 18 years of age.
    2. The subject must have cytologically or histologically confirmed non-squamous NSCLC. Subjects may have a mixed histology but must be predominantly non- squamous to be eligible.
    3. The subject must have recurrent or advanced (Stage IIIb with pleural or pericardial
    effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection
    or radiation with curative intent.
    4. The subject has measurable disease, defined as at least 1 unidimensionally
    measurable lesion on a computed tomography (CT) scan as defined by RECIST
    (for subjects in the randomized portion only).
    5. The subject has an ECOG Performance Score of 0-1.
    6. The subject must have adequate bone marrow, renal and hepatic function. Please refer to section 5.2.1 of the study protocol for further information.
    7. Women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study
    participation and up to two months following completion of therapy.
    ● Total abstinence from sexual intercourse (minimum one complete menstrual
    cycle);
    ● A vasectomized partner;
    ● Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration;
    ● Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal
    ring with spermicidal jellies or cream).
    Women of childbearing potential must have a negative urine pregnancy test
    within 7 days prior to initiation of treatment and/or post menopausal women must
    be amenorrheic for at least 12 months to be considered of non-childbearing
    potential.
    8. The subject is capable of understanding and complying with parameters as
    outlined in the protocol and able to sign and date the informed consent approved
    by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB),
    prior to the initiation of any screening or study-specific procedures.
    E.4Principal exclusion criteria
    1. The subject has hypersensitivity to paclitaxel or to other drugs formulated with
    polyethoxylated castor oil (Cremophor).
    2. The subject has received any anti-cancer therapy for treatment of NSCLC
    including investigational agents, immunotherapy, traditional Chinese
    medicine/herbal remedies, hormonal, "targeted" agents (i.e., erlotinib, imatinib),
    biologic therapy or cytotoxic chemotherapy (i.e., alkalating agents, microtubule
    inhibitors, antimetabolites).
    3. Subject has received radiation therapy within 21 days of Study Day 1.
    4. The subject has had major surgery within 21 days.
    5. The subject has untreated brain or meningeal metastases. CT scans are not
    required to rule out brain or meningeal metastases unless there is a clinical
    suspicion of central nervous system disease. Subjects with treated brain
    metastases that are radiographically or clinically stable for at least 4 weeks after
    therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are
    eligible, providing that they are asymptomatic, and do not require corticosteroids
    (must have discontinued steroids at least 1 week prior to study drug
    administration).
    6. The subject is receiving therapeutic anticoagulation therapy. Low dose
    anticoagulation (e.g., low dose Warfarin®) for catheter prophylaxis will be
    permitted.
    7. The subject has a central thoracic tumor lesion as defined by location within the
    hilar structures. The presence of central nodal disease is allowed.
    8. The subject has proteinuria CTC Grade > 1 at baseline as measured by a UPC ratio
    of > 1 and confirmed by a 24-hour urine collection.
    9. The subject has a history of, or currently exhibits clinically significant cancer
    related events of bleeding (e.g., gross hemoptysis defined as bright red blood of at
    least ½ teaspoon or 2.5 mL per episode within 3 months prior to randomization
    unless definitively treated with surgery or radiation), or the subject has a recent
    history of (within 4 weeks of Study Day 1), or currently exhibits other clinically
    significant signs of bleeding.
    10. The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg. Subjects may be re-screened if BP is shown to be controlled with or without intervention.
    11. The subject has a history of myocardial infarction, stroke or Transient Ischemic
    Attack (TIA) within 6 months of Study Day 1.
    12. The subject has a documented left ventricular (LV) ejection fraction < 50%.
    13. The subject has known autoimmune disease with renal involvement (i.e., lupus).
    14. The subject is receiving combination anti-retroviral therapy for HIV.
    15. The subject has clinically significant uncontrolled condition(s) including but not
    limited to:
    ● Active uncontrolled infection;
    ● Symptomatic congestive heart failure;
    ● Unstable angina pectoris or cardiac arrhythmia;
    ● History of adrenal insufficiency; or
    ● Psychiatric illness/social situation that would limit compliance with study
    requirements.
    16. The subject has a history of another active cancer within the past 5 years except
    cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell
    carcinoma of the skin. Questions regarding inclusion of individual subjects should
    be directed to the Abbott Medical Monitor.
    17. The subject has active ulcerative colitis, Crohn's disease, celiac disease or any
    other conditions that interfere with absorption.
    18. The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
    19. The subject is pregnant or breast feeding.
    20. The subject has NSCLC with a predominant squamous cell histology.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is progression-free survival (PFS). The secondary endpoints of the study are overall survival, 12-month survival rate, time to
    disease progression (TTP), objective response rate, best response rate, best percent
    change in tumor size, duration of response as well as the safety and tolerability of the combination. The tertiary endpoints are QoL, performance status and body weight.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States No
    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 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 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
    The end of study is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is longer.
    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 months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months16
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-06-03. Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 120
    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)
    Please refer to section 5.4.1.3 of the clinical study protocol for details. Following discontinuation of the study drug, subjects will be treated in accordance with the investigator's best clinical judgement.
    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 Decision2009-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-04
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