Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2006-003298-28
    Sponsor's Protocol Code Number:M06-822
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-003298-28
    A.3Full title of the trial
    A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Small Cell Lung Cancer (SCLC) or other non-hematological malignancies.
    A.4.1Sponsor's protocol code numberM06-822
    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 Laboratories Limited (Queenborough, Kent, ME11 5EL, England)
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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-263
    D.3.2Product code ABT-263
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.2Current sponsor codeABT-263
    D.3.9.3Other descriptive nameA-855071.3
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.0
    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 Information not present in EudraCT
    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
    Small cell lung carcinoma (SCLC) (North America or UK) and other non-hematological malignancies (North America only).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10041067
    E.1.2Term Small cell lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1:
    - safety assessment
    - dose limiting toxicity 9DLT) determination
    - maximum tolerated dose (MTD) determination
    - pharmacokinetic profile evaluation
    Phase 2:
    - safety assessment at the recommended Phase 2 dose (RPTD)
    - preliminary efficacy assessment
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Diagnostic Tissue Sub-study
    Objective: to develop a test from tissue biopsy which identifies patients most likely to respond to the study drug ABT-263.

    Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) will be performed on tissue slides from archived, diagnostic, formalin fixed, paraffin embedded (FFPE) tissue blocks from patients who consent.

    Title: Genetic sub-study
    Objective: to identify genetic reasons for patients with small cell lung cancer and if they would benefit from taking ABT-263.

    One 4ml of blood sample for DNA isolation will be collected at screening from each subject that consents.

    E.3Principal inclusion criteria
    Phase 1
    1. The subject must be ≥ 18 years of age.
    2. The subject must have histologically documented diagnosis of small cell lung
    cancer (North America and UK) or other non-hematological malignancy (North
    America only) measurable by CT or MRI as defined by RECIST. Target lesion(s)
    may not have received radiation therapy.
    3. The subject has received at least 1 prior chemotherapy treatment regimen(s) and
    their disease is refractory or the subject has experienced progressive disease
    following the treatment.
    4. Subjects with brain metastases must have clinically controlled neurologic
    symptoms, defined as surgical excision and/or radiation therapy followed by
    21 days of stable neurologic function and no evidence of CNS disease progression
    as determined by CT or MRI within 21 days prior to the first dose of study drug.
    5. The subject has an Eastern Cooperative Oncology Group performance score
    of ≤ 2.
    6. Subjects receiving Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants
    (e.g., Prozac) must be receiving a stable dose for at least 21 days prior to the first
    dose of study drug.
    7. Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range at Screening (see protocol).
    8. Female subjects must be surgically sterile, postmenopausal (for at least one year), or have negative results for a pregnancy test (see protocol for details of pregancy test)
    9. All female subjects not surgically sterile or postmenopausal (for at least one year) and non-vasectomized male subjects must practice suitable method(s) of birth control (as defined in the protocol).
    10. The subject, or legal representative, must voluntarily sign and date an informed consent, apprpved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
    11. In the Investigator's opinion, the subject's life expectancy is at least 30 days.

    Phase 2a:

    Criteria 1,4,6,7,8,9, 10, 11 for phase 1, plus criteria (numbered as they appear in the protocol):
    2. The subject must have histologically documented diagnosis of small cell lung
    cancer (SCLC).
    3. The subject has extensive-stage SCLC and is chemotherapy naïve (US only) or the
    subject has experienced progressive disease following at least one chemotherapy
    regimen or their disease is refractory.
    5. Subjects with brain metastases must have clinically controlled neurologic
    symptoms, defined as surgical excision and/or radiation therapy followed by
    21 days of stable neurologic function and no evidence of CNS disease progression
    as determined by CT or MRI within 21 days prior to the first dose of study drug.
    12. The subject, or legal representative, must voluntarily sign and date an informed
    consent, approved by an Independent Ethics Committee (IEC)/Institutional Review
    Board (IRB), prior to the initiation of any screening or study-specific procedures.
    13. In the investigator's opinion, the subject's life expectancy is at least 30 days.
    E.4Principal exclusion criteria
    Phases 1 & 2a

    1. The subject has an underlying, predisposing condition of bleeding or currently
    exhibits signs of bleeding. The subject has a recent history of non-chemotherapy
    induced thrombocytopenia-associated bleeding within one year prior to first dose
    of study drug.
    2. The subject has active peptic ulcer disease or other potentially hemorrhagic
    esophagitis/gastritis.
    3. The subject has a history of platelet autoantibodies or autoimmune phenomena
    including immune thrombocytopenic purpura (ITP) or autoimmune hemolytic
    anemia (AIHA).
    4. Subject is currently receiving or requires anticoagulation therapy or any drugs or
    herbal supplements that affect platelet function, with the exception of low-dose
    anticoagulation medications that are used to maintain the patency of a central
    intravenous catheter.
    5. The subject has received any anti-cancer therapy including chemotherapy,
    immunotherapy, radiotherapy, hormonal (with the exception of hormones for
    hypothyroidism or estrogen replacement therapy (ERT), biologic (with the
    exception of colony stimulating factors [G-CSF, GM-CSF] or erythropoietin), or
    any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 clinically significant adverse
    effect(s)/toxicity(s) of the previous therapy.
    6. The subject has consumed grapefruit or grapefruit products within 3 days prior to
    the first dose of study drug.
    7. The subject has a significant history of cardiovascular disease (e.g., MI,
    thrombotic or thromboembolic event in the last 6 months), renal, neurologic,
    psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the
    opinion of the investigator would adversely affect his/her participating in this
    study. Questions regarding inclusion of individual subjects should be directed to
    the Abbott Medical Monitor or designee.
    8. A female subject is pregnant or breast-feeding.
    9. The subject has tested positive for HIV (due to potential drug-drug interactions
    between anti-retroviral medications and ABT-263, as well as anticipated ABT-263
    mechanism based lymphopenia that may potentially increase the risk of
    opportunistic infections and potential drug-drug interactions with certain
    anti-infective agents).
    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. 11. The subject exhibits evidence of other clinically significant uncontrolled
    condition(s) including, but not limited to:
    ● active systemic fungal infection;
    ● diagnosis of fever and neutropenia within one week prior to study drug
    administration.
    12. Subject has received aspirin within seven days prior to the first dose of study drug.
    13. The subject has received steroid therapy within seven days prior to the first dose of
    study drug with the exception of inhaled steroids for asthma, topical steroids, or
    replacement/stress corticosteroids.
    E.5 End points
    E.5.1Primary end point(s)
    As this is Phase 1/2a study, there is no primary endpoint.
    The objectives of the Phase 1 study include:
    ● Safety assessment
    ● Dose limiting toxicity (DLT) determination
    ● Maximum tolerated dose (MTD) determination
    ● Pharmacokinetic profile evaluation

    The objectives of the Phase 2a study include:
    ● Safety assessment at the recommended Phase 2 dose (RPTD)
    ● Preliminary efficacy assessment
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 90
    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 Decision2006-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-29
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 11:02:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA