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    Summary
    EudraCT Number:2007-005245-37
    Sponsor's Protocol Code Number:M06-880
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-02-22
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-005245-37
    A.3Full title of the trial
    An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
    A.4.1Sponsor's protocol code numberM06-880
    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
    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.3.8INN - Proposed INNNone
    D.3.9.1CAS number 796967-16-3
    D.3.9.2Current sponsor codeABT-869
    D.3.9.3Other descriptive nameA-741439
    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
    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.3.8INN - Proposed INNNone
    D.3.9.1CAS number 796967-16-3
    D.3.9.2Current sponsor codeABT-869
    D.3.9.3Other descriptive nameA-741439
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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 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 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 LLT
    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 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 PT
    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 determine the efficacy of 0.10 mg/kg and 0.25 mg/kg ABT-869 using Response Evaluation Criteria in Solid Tumors (RECIST) criteria and to establish the safety/tolerability profile of ABT-869 in subjects with advanced or metastatic NSCLC.
    E.2.2Secondary objectives of the trial
    To identify potential biomarkers that correlate and/or predict efficacy and toxicity in subjects with advanced or metastatic NSCLC and to explore if there are any ethnic differences in tumor response to ABT-869 between Asian and non-Asian NSCLC populations. The tertiary objectives of this study are to assess additional efficacy endpoints such as quality of life, changes in weight and performance status.
    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 that have signed the appropriate Informed Consent From, 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 that encode drug metabolizing enzymes (such as cytochromes 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. Subject must be ≥ 18 years of age.
    2. Subject must be histologically or cytologically diagnosed with locally advanced or
    metastatic NSCLC.
    3. Subjects must have at least one lesion measurable by CT scan as defined by
    RECIST. The measurable lesion may have not received radiation therapy.
    4. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status
    of 0-2.
    5. Subject has received at least one prior line of systemic treatment but no more than two treatment regimens for locally advanced or metastatic NSCLC. In addition,
    the subject may have received systemic neo-adjuvant or adjuvant chemotherapy for NSCLC.
    6. Subject must have the following laboratory values:
    ● Total Bilirubin ≤ 1.5 × upper normal limit (ULN)
    ● AST/ALT ≤ 2.5 × ULN or ≤ 5.0 ULN if subject has liver metastasis
    ● PTT ≤ 1.5 × ULN and INR ≤ 1.5
    ● ANC ≥ 1.0 × 109/L
    ● Platelet count ≥ 75 × 109/L
    ● Creatinine ≤ 1.5 × ULN
    7. No other active malignancy within the past 5 years except for cervical cancer in
    situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
    8. Women of childbearing potential and men 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. 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.
    ● 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)
    9. 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. Subject has received anti-cancer therapy within 21 days or 5 half lives, whichever
    is shorter, prior to study drug administration. Anti-cancer therapies include but are
    not limited to: investigational agents, immunotherapy, anti-cancer traditional
    Chinese medicine/herbal remedies, hormonal, targeted agents (i.e., erlotinib,
    imatinib) or biologic therapy. Subject has received cytotoxic chemotherapy (i.e.,
    alkylating agents, microtubule inhibitors, anti-metabolites) within 21 days prior to study drug administration. In addition, subject has not recovered to ≤ Grade 1
    clinically significant adverse effects/toxicities of previous therapy.
    2. Subject has received radiation or undergone major surgery within the previous
    21 days prior to study drug administration.
    3. Subject has received targeted VEGF/PDGF TKI (tyrosine kinase inhibitor) therapy
    (prior Avastin is allowed).
    4. 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 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).
    5. History of greater than 10% weight loss during the 6 weeks prior to study entry.
    6. Subject has significant central thoracic lesions invading or abutting the heart or
    major blood vessels with any appreciable cavitation.
    7. Subject has clinically relevant hemoptysis described as > 5 ml fresh blood within
    the last 3 months. Subjects with only flecks of blood in sputum are permitted.
    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 currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood
    pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to
    be controlled with or without intervention.
    10. The subject has a documented left ventricular ejection fraction < 50%.
    11. Subject is receiving therapeutic anticoagulation therapy. Low dose
    anti-coagulation (e.g., low dose Warfarin) for catheter prophylaxis only will be
    permitted. No low molecular weight heparin is allowed.
    12. Subject is receiving anti-retroviral therapy for HIV.
    13. Female subjects who are pregnant or breast-feeding.
    14. Clinically significant uncontrolled condition(s) including:
    ● Active uncontrolled infection
    ● Class III or IV heart failure as defined by the New York Heart Association
    functional classification system
    ● Unstable angina pectoris or cardiac arrhythmia
    ● Myocardial infarction within last 6 months
    ● History of adrenal insufficiency
    ● History of hemorrhagic cerebral vascular accident within last 6 months
    ● Active ulcerative colitis, Crohn's disease, celiac disease or any other
    conditions that interfere with absorption
    ● History of autoimmune disease that has kidney involvement
    ● History of overt bleeding (> 30 mL bleeding/episode) within 3 months of
    study drug administration
    ● Psychiatric illness/social situation that would limit compliance with study
    requirements
    ● Any other medical condition, which in the opinion of the study investigator
    places the subject at an unacceptably high risk for toxicities.
    E.5 End points
    E.5.1Primary end point(s)
    Determine the efficacy of low and high dosages using RECIST and establish safety and tolerability of ABT-869 in NSCLC.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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
    Option for patients in low dose group 0.10 mg/kg of ABT-869 to cross-over to 0.25 mg/kg dose
    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
    Different dose of the same IMP
    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.8.5The 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 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 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 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 months12
    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.1.3Elderly (>=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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    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 5.4.1.2 of the clinical study protocol for details. Following discontinuation of the study drug, the subject will be treated in accordance with the investigator's best clinical judgment.
    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 Decision2008-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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