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    Summary
    EudraCT Number:2006-002830-38
    Sponsor's Protocol Code Number:M05-780
    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:2006-09-14
    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 number2006-002830-38
    A.3Full title of the trial
    A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination with Pemetrexed Versus Pemetrexed Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberM05-780
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Alimta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA, Houten, The Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAlimta
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPemetrexed
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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*
    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 only, is to determine the maximum tolerated dose (MTD) of ABT-751 when administered daily for 14/21 days, in combination with standard pemetrexed (500 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 + pemetrexed compared to pemetrexed 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 pemetrexed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 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 either during or following the
    previous chemotherapy regimen.
    8. The subject exhibits 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 0-2.
    11. All anti-tumor therapy has been discontinued at least 3 weeks prior to study start
    administration.
    12. All adverse events from prior anti-tumor treatment are resolved or stable.
    13. Adequate hematologic, renal and hepatic function: no NYHA Class 3-4 heart failure
    14. Female subjects must be surgically sterile, postmenopausal (for at least 1 year), or have negative results for a serum pregnancy test.
    15. 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;
    ● Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to and during study drug administration;
    Double-barrier method (condoms, contraceptive sponge, diaphragm, or
    vaginal ring with spermicidal jellies or creams).
    16. The subject's life expectancy is ≥ 3 months.
    17. The subject is amenable to completing the Quality of Life (QoL) questionnaire.
    18. Subject has voluntarily signed and dated an informed consent form, approved by
    an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to
    any study-specific procedures.
    E.4Principal exclusion criteria
    1. The subject has greater than Grade 1 NCI CTCAE (Version 3.0) neurology
    category findings (e.g., paresthesia, deep tendon reflexes, or weakness that is
    subjective and/or does not interfere with function).
    2. The subject has a documented allergy to sulfa medications.
    3. The subject has previously received ABT-751 or pemetrexed.
    4. 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.)
    5. The subject exhibits significant weight loss (≥ 10%) during the 6 weeks before
    study entry.
    6. The subject has glucose-6-phosphate dehydrogenase deficiency and/or porphyria.
    7. 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.
    8. 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.
    9. A female subject is pregnant or breastfeeding.
    10. 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) confined
    and surgically resected with no evidence of disease within three years of
    initiation of study
    ● 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)
    The primary efficacy analysis will be a comparison of PFS (radiologic progression as
    determined by the Central Imaging Center, clinical progression as determined by the investigator, or death) distributions between the pemetrexed + ABT-751 and
    pemetrexed + placebo treatment groups.
    For a given subject, PFS will be defined as the number of days from the day the subject was randomized to the day the subject experiences a confirmed event of disease progression (radiologic progression as determined by the Central Imaging Center or clinical progression as determined by the investigator) or to the date of death (all causes of mortality) if disease progression is not reached. All events of disease progression will be included, regardless of whether the event occurred while the subject was still taking study drug or had previously discontinued study drug. All events of death will be included for subjects who had not experienced disease progression provided the death occurred within 42 days of the last tumor assessment, vital sign measurement, performance status assessment, or physical exam, whichever is latest. If the subject does not have a confirmed event of disease progression nor has the subject died, the subject's data will be censored at the date of the subject's last available tumor assessment, vital sign measurement, performance status assessment, or physical exam, whichever is last.
    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: 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 years1
    E.8.9.1In the Member State concerned months6
    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 2006-09-14. 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 state42
    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 Decision2006-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-05
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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