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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:2006-002838-38
    Sponsor's Protocol Code Number:M05-782
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-01-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2006-002838-38
    A.3Full title of the trial
    A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination with Docetaxel Versus Docetaxel Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberM05-782
    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-751
    D.3.2Product code ABT-751
    D.3.4Pharmaceutical form Capsule, hard
    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 N-[2-[(4-hyd
    D.3.9.2Current sponsor codeABT-751, A-254751.0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 to 100
    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 placeboCapsule, hard
    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
    Advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following one or more chemotherapy regimens.

    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the Phase 1 portion of the study, which will be conducted in the US and Canada only, is to determine the maximum tolerated dose (MTD) of ABT-751 when administered daily for 14/21 days, in combination with standard docetaxel (75 mg/m2 every 21 days).The primary objective of the Phase 2 portion of the study (estimated to begin enrollment in Sep-Nov 2006) is to assess the impact on progression-free survival of the combination of ABT-751 docetaxel compared to docetaxel alone in subjects with NSCLC who have received at least one prior chemotherapy regimen.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the Phase 2 portion of the study will be overall survival, response rate, duration of response, time-to-progression (TTP), quality of life (QoL), and to characterize toxicities associated with ABT-751 when administered in combination with docetaxel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is ≥ 18 years old.
    2. The subject has histologically-documented NSCLC.
    3. The subject has locally advanced (Stage III) or metastatic (Stage IV) NSCLC not
    amenable to curative surgery or radiotherapy.
    4. The subject has received at least 1 prior treatment regimen for NSCLC in the
    neo-adjuvant, adjuvant or metastatic setting.
    5. The subject has received no more than 2 prior treatment regimens for NSCLC
    (i.e., study participation must be second-line therapy in the metastatic setting).
    6. The subject has received no more than 1 chemotherapy treatment regimen in the
    metastatic setting.
    7. The subject has experienced progressive disease following the previous
    chemotherapy regimen.
    8. The subject has the presence of measurable disease by RECIST criteria.
    9. Subjects with brain metastases must have had clinically controlled neurologic
    symptoms, defined as surgical excision and/or radiation therapy followed by
    30 days of stable neurologic function and no evidence of CNS disease progression.
    (Subjects with symptoms of CNS metastasis at Screening must have computed
    tomography [CT] or magnetic resonance imaging [MRI] scans of the brain prior to
    study entry that demonstrate no evidence of disease.)
    10. The subject has an Eastern Cooperative Oncology Group (ECOG) performance
    score of ≤ 2.
    11. All prior anti-tumor therapy must be discontinued at least 3 weeks prior to
    ABT-751/placebo and docetaxel administration.
    12. All adverse events from prior anti-tumor treatment are resolved or stable.
    13. The subject's life expectancy is ≥ 3 months.

    14. The subject must have adequate hematologic, renal and hepatic function as
    follows:
    Hematology
    Absolute Neutrophil Count (ANC) ≥ 2000/mm3
    Platelet Count ≥ 100,000/mm3
    Hemoglobin ≥ 9.0 g/dL
    Renal Function
    Creatinine Serum ≤ 2.0 mg/dL or
    Creatinine Clearance ≥ 45 mL/mina
    Hepatic Function
    Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL with liver metastasis)b
    Serum Glutamic-Oxaloacetic
    Tranaminase (SGOT)
    ≤ 2.5 × ULN (≤ 5.0 × ULN with liver metastasis)
    Serum Glutamic-Pyruvic
    Tranaminase (SGPT)
    ≤ 2.5 × ULN (≤ 5.0 × ULN with liver metastasis)
    a. If calculated creatinine clearance is < 45 mL/min, a 24-hour urine collection for creatinine clearance
    may be performed.
    b. Subjects with Gilbert's disease may have bilirubin up to 2.5 mg/dL (or 3.0 mg/dL with liver
    metastasis).
    15. Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or
    have negative results for a serum pregnancy test.
    16. All female subjects not surgically sterile or postmenopausal (for at least 1 year)
    and non-vasectomized male subjects must practice at least one of the following
    methods of birth control:
    ● Total abstinence from sexual intercourse during the study (minimum one
    complete menstrual cycle prior to study start);
    ● Vasectomized partner;
    ABT-751
    M05-782 Protocol Amendment 2
    EudraCT 2006-002838-38
    ● Hormonal contraceptives (oral, parenteral, or transdermal) for at least
    3 months prior to and during study drug administration;
    ● Double-barrier method (condoms, contraceptive sponge, or vaginal ring with
    spermicidal jellies or creams).
    17. The subject is amenable to completing the Quality of Life (QoL) questionnaire.
    18. The subject has voluntarily signed and dated an informed consent form, approved
    by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB),
    prior to any non-routine study-specific procedures.
    E.4Principal exclusion criteria
    1. The subject has NCI CTCAE (version 3.0) neurology category findings
    (e.g., paresthesia, impaired deep tendon reflexes, or weakness) greater than
    Grade 1.
    2. The subject has a documented allergy to sulfa medications.
    3. The subject has glucose-6-phosphate dehydrogenase deficiency.
    4. The subject has porphyria.
    5. The subject has previously received ABT-751 or docetaxel.
    6. The subject has received more than one investigational agent for NSCLC
    as a single agent or part of a previous regimen. (An investigational agent is any
    drug not currently approved for use in humans. Please contact the Abbott medical
    monitor with questions regarding investigational agents.)
    7. The subject exhibits significant weight loss (≥ 10%) during the 6 weeks before
    study entry.
    8. The subject has a significant history of cardiac, renal, neurologic, psychiatric,
    endocrinologic, metabolic, or hepatic disease that would adversely affect his/her
    participating in this study. Questions regarding inclusion of individual subjects
    should be directed to the Abbott medical monitor.
    9. The subject has a current history of a Class 3-4 cardiovascular disability status in
    accordance with the New York Heart Association Functional Classification.
    ● Class 3 is defined as marked limitation of physical activity, comfortable at
    rest, but less than ordinary activity causes fatigue or dyspnea.
    ● Class 4 is defined as being unable to carry on any physical activity without
    symptoms and symptoms are present even at rest. Also, if any physical
    activity is undertaken, symptoms are increased.
    10. A female subject who is pregnant or breastfeeding.
    11. The subject has previous or current malignancies at other sites, with the exception
    of:
    ● adequately treated in situ carcinoma of the cervix uteri;
    ● basal or squamous cell carcinoma of the skin;
    ● previous nonpulmonary malignancy (e.g., localized prostate cancer) surgically
    resected or curatively treated with no evidence of disease within three years of
    study initiation.
    ● previous nonpulmonary malignancy, which has been treated with surgery,
    chemotherapy, or radiation therapy and is considered cured by the
    investigator, may be approved by the Abbott Medical Monitor.
    E.5 End points
    E.5.1Primary end point(s)
    Primary - Progression-free survival
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Determine the maximum tolerated dose (MTD)
    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 Yes
    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
    Phase 1/2 Study : Open-label, Phase II: double-blind
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 2007-01-11. 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 180
    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 Decision2007-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-12-11
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