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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:2007-002143-25
    Sponsor's Protocol Code Number:M06-873
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-12
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2007-002143-25
    A.3Full title of the trial
    A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia.
    A.4.1Sponsor's protocol code numberM06-873
    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-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.3.8INN - Proposed INNNavitoclax (proposed INN)
    D.3.9.2Current sponsor codeABT-263
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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-263
    D.3.2Product code ABT-263
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNNavitoclax (proposed INN)
    D.3.9.2Current sponsor codeABT-263
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Relapsed or Refractory Chronic Lymphocytic Leukemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008978
    E.1.2Term Chronic lymphocytic leukemia refractory
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the Phase 1 portion of the study include:
    ● Safety assessment
    ● Dose limiting toxicity (DLT) determination
    ● Maximum tolerated dose (MTD) determination
    ● Pharmacokinetic profile evaluation

    The objectives of the Phase 2a portion of the study include:
    ● Safety assessment at the recommended Phase 2 dose (RPTD) and schedule determination
    ● Preliminary efficacy assessment including biomarker assessment
    ● Pharmacokinetic profile evaluation
    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
    Biomarker sub-study as part of main study protocol, version 29 April 2008:
    Several putative biomarkers of efficacy and response will be evaluated to define the relationship between drug concentration and disease status.

    Pharmacogenetic sub-study as part of main study protocol, version 29 April 2008:
    DNA samples may be analyzed for genetic factors contributing to the subject's response to ABT-263 in terms of pharmacokinetics and safety and may also be used for the development of a diagnostic test for drug response.
    E.3Principal inclusion criteria
    Phase 1 Inclusion Criteria
    A subject will be eligible for study participation if he/she meets the following criteria:

    1. The subject must be ≥ 18 years of age.
    2. The subject must have alemtuzumab-refractory CLL or relapsed or refractory CLL
    with contraindications against the use of alemtuzumab and require treatment in the
    opinion of the investigator.
    3. The subject has an Eastern Cooperative Oncology Group performance score
    of ≤ 1.
    4. 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.
    5. The subject must have adequate bone marrow, renal and hepatic function. Please see protocol for more information.
    6. Female subjects must be surgically sterile, postmenopausal (for at least one year),
    or have negative results for a pregnancy test. Please see protocol for more information.
    7. All female subjects not surgically sterile or postmenopausal (for at least one year)
    and non-vasectomized male subjects must practice at least one of the methods of birth control described in the protocol.
    8. The subject 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.

    Phase 2a Inclusion Criteria
    A subject will be eligible for study participation if he/she meets the following criteria:

    1. The subject must be ≥ 18 years of age.
    2. The subject must have CLL and require treatment in the opinion of the
    investigator.
    3. The subject has alemtuzumab-refractory disease or the subject has relapsed disease with contraindications against the use of alemtuzumab and has received no more than 5 prior myelosuppressive/chemotherapy regimens (see Section 5.1).
    4. Subject has an Eastern Cooperative Oncology Group performance score of ≤ 1.
    5. 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.
    6. The subject must have adequate bone marrow independent of growth factor support (with the exception of subjects with ANC < 1000/μL and bone marrow heavily infiltrated with underlying disease [80% or more]), renal and hepatic function, per local laboratory reference range at Screening as follows:
    7. Female subjects must be surgically sterile, postmenopausal (for at least one year),
    or have negative results for a pregnancy test. Please see protocol for more information.
    8. All female subjects not surgically sterile or postmenopausal (for at least one year)
    and non-vasectomized male subjects must practice at least one of the methods of birth control described in the protocol.
    9. The subject 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.
    E.4Principal exclusion criteria
    Phase 1 and Phase 2a Exclusion Criteria
    A subject will not be eligible for study participation if he/she meets any of the following criteria:

    1. The subject has a history or is clinically suspicious for cancer-related Central
    Nervous System (CNS) disease.
    2. The subject has a recent history (within 1 year prior to first dose of study drug) of
    an underlying, predisposing condition of bleeding or currently exhibits signs of
    bleeding.
    3. The subject has undergone an allogeneic or autologous stem cell transplant.
    4. The subject has active peptic ulcer disease or other potentially hemorrhagic
    esophagitis/gastritis.
    5. The subject has active immune thrombocytopenic purpura or a history of being
    refractory to platelet transfusions (within 1 year prior to the first dose of study
    drug).
    6. The 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.
    7. Subject has received steroid therapy for anti-neoplastic intent 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.
    8. The subject has received aspirin within seven days prior to the first dose of study
    drug.
    9. The subject has received any anti-cancer therapy including chemotherapy,
    immunotherapy, radiotherapy, hormonal (with the exception of hormones for
    thyroid conditions or estrogen replacement therapy [ERT]), or any investigational
    therapy within 14 days prior to the first dose of study drug, or has not recovered to
    less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of the
    previous therapy.
    10. The subject has received a biologic within 30 days prior to the first dose of study
    drug.
    11. The subject has consumed grapefruit or grapefruit products within 3 days prior to
    the first dose of study drug.
    12. The subject has a significant history of cardiovascular disease (e.g., myocardial
    infarction [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.
    13. A female subject is pregnant or breast-feeding.
    14. 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).
    15. The subject has a history of other active malignancies within the past 3 years prior to study entry, with the exception
    of:
    ● adequately treated in situ carcinoma of the cervix uteri;
    ● basal or squamous cell carcinoma of the skin;
    ● previous malignancy confined and surgically resected with curative intent. 16. The subject exhibits evidence of other clinically significant uncontrolled
    condition(s) including, but not limited to:
    ● uncontrolled systemic infection (viral, bacterial, or fungal);
    ● diagnosis of fever and neutropenia within one week prior to study drug
    administration.
    17. The subject has received known CYP3A inhibitors (e.g., ketoconazole) within 7 days prior to first dose of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Assessment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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
    A Phase 1/2a Study Evaluating Safety, Pharmacokinetics and Efficacy
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Defined in the Protocol 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 years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    non-vasectomized male subjects must use contraception.
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 72
    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)
    Subject should discuss standard of care treatment options with his/her physician once participation in the trial has ended.
    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 Decision2007-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
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