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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:2007-007081-38
    Sponsor's Protocol Code Number:M10-300
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-20
    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 ConcernedGreece - EOF
    A.2EudraCT number2007-007081-38
    A.3Full title of the trial
    An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer
    A.4.1Sponsor's protocol code numberM10-300
    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, A-741439.0
    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.3.9.1CAS number 796967-16-3
    D.3.9.2Current sponsor codeABT-869, A-741439.0
    D.3.9.3Other descriptive name1-[4-(3-Amino-1H-indazol-4-yl)phenyl]-3 -(2-fluoro-5-methylphenyl)urea
    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, A-741439.0
    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.3.9.1CAS number 796967-16-3
    D.3.9.2Current sponsor codeABT-869, A-741439.0
    D.3.9.3Other descriptive name1-[4-(3-Amino-1H-indazol-4-yl)phenyl]-3 -(2-fluoro-5-methylphenyl)urea
    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.IMP: 3
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBevacizumab
    D.3.9.3Other descriptive nameBEVACIZUMABUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 colorectal cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010030
    E.1.2Term Colorectal cancer recurrent
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010035
    E.1.2Term Colorectal cancer stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess if the addition of oral ABT-869 to mFOLFOX6 (5-fluorouracil, folinic acid, and oxaliplatin) can prolong progression-free survival (PFS) compared to bevacizumab plus mFOLFOX6 as second-line treatment in subjects with advanced colorectal cancer.
    E.2.2Secondary objectives of the trial
    To evaluate overall survival and additional efficacy endpoints (listed in Section 8.1.6 of the study protocol), as well as the safety and tolerability of the combination.

    The tertiary objectives are to evaluate quality of life 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 who have signed the appropriate Informed Consent Form, 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 encode drug metabolizing enzymes (such as cytochrome P450s 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. Other genes potentially related to ABT-869 response, such as genes for targets (such as VEGF or PDGF RTKs), disease progression or kinase inhibitor responsivity, may also be assessed.
    E.3Principal inclusion criteria
    1. The subject must be ≥ 18 years of age.
    2. The subject must be diagnosed with adenocarcinoma of the colon or rectum.
    3. The subject must have metastatic disease or locally recurrent disease that is not
    amenable to surgical resection with curative intent.
    4. The subject must have received one prior chemotherapy regimen containing
    irinotecan or a fluoropyrimidine for locally recurrent or metastatic colorectal
    cancer. The subject has experienced progressive disease during or following the
    prior chemotherapy treatment.
    5. The subject may have received prior adjuvant treatment for colorectal cancer.
    6. The subject has measurable disease, defined as at least 1 unidimensionally
    measurable lesion on a CT scan as defined by RECIST (for subjects in the
    randomized portion only).
    7. The subject has an Eastern Cooperative Oncology Group (ECOG) performance
    score of 0-1.
    8. The subject must have adequate bone marrow, renal and hepatic function. Please refer to Section 5.2.1 of the study protocol for further information.
    9. The subject must have PTT ≤ 1.5 × ULN and INR ≤ 1.5.
    10. Female subjects of childbearing potential must have a negative urine pregnancy
    test within 7 days prior to initiation of treatment, must be surgically sterile and/or
    post menopausal women must be amenorrheic for at least 12 months to be
    considered of non-childbearing potential. Female subjects of childbearing
    potential and male subjects 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.
    ● 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).
    11. The 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. The subject has received cytotoxic chemotherapy (i.e. alkylating agents,
    microtubule inhibitors, anti-metabolites) within 21 days prior to Study Day 1.
    2. The subject has received non-cytotoxic, anti-cancer therapy within 21 days or
    within a period defined by 5 half lives whichever is shorter, prior to study drug
    administration. Anti-cancer therapies include, but are not limited to:
    investigational agents (any agent not approved for use in humans),
    immunotherapy, anti-cancer traditional Chinese medicine/herbal remedies,
    hormonal, "targeted" agents (i.e., erlotinib, imatinib) or biologic therapy.
    3. The subject has not recovered to less than or equal to Grade 1 clinically significant
    adverse effects/toxicities of the previous therapy.
    4. The subject has received prior treatment with bevacizumab or a tyrosine kinase
    inhibitor targeting VEGF or PDGF. Lead-in cohort only: Prior treatment with
    bevacizumab will be allowed, but not within 7 weeks of ABT-869 administration.
    5. The subject has received prior treatment for colorectal cancer with oxaliplatin in
    the metastatic setting.
    6. The subject has had major surgery within 28 days of Study Day 1.
    7. The subject has had radiotherapy within 14 days of Study Day 1.
    8. The subject has symptomatic or 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).
    9. The subject has a history of hypersensitivity to recombinant murine monoclonal
    antibodies, oxaliplatin or other platinum-containing compounds, 5-fluorouracil, or
    folinic acid.
    10. The subject has proteinuria CTC grade > 1 at baseline as measured by a UPCR
    of > 1 and confirmed by a 24-hour urine collection.
    11. The subject is receiving therapeutic anticoagulation therapy. Low dose
    anticoagulation (e.g., low dose warfarin) for catheter prophylaxis will be permitted.
    12. The subject has a history of, or currently exhibits, clinically significant cancer
    related events of bleeding (e.g., gross hemoptysis defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode within three months prior to Study Day 1 unless definitively treated with surgery or radiation) or the subject has a recent
    history of (within four weeks of Study Day 1) or currently exhibits other clinically
    significant signs of bleeding.
    13. The subject currently exhibits symptomatic or persistent, uncontrolled
    hypertension defined as diastolic blood pressure (BP) > 100 mmHg; or systolic
    blood pressure (BP) > 150 mmHg. Subjects may be re-screened if blood pressure
    is shown to be controlled with or without intervention.
    14. The subject has a history of myocardial infarction, stroke, or transient ischemic
    attack (TIA) within six months of Study Day 1.
    15. The subject has a history of abdominal fistula or gastrointestinal perforation within six months prior to Study Day 1.
    16. The subject has a documented left ventricular (LV) ejection fraction < 50%.
    17. The subject has known autoimmune disease with renal involvement (e.g., lupus).
    18. The subject is receiving combination anti-retroviral therapy for HIV.
    19. Female subject is pregnant or breast-feeding.
    20. The subject has clinically significant uncontrolled condition(s) including but not
    limited to:
    ● active uncontrolled infection,
    ● symptomatic congestive heart failure,
    ● unstable angina pectoris or cardiac arrhythmia,
    ● history of adrenal insufficiency,
    ● psychiatric illness/social situation that would limit compliance with study
    requirements.
    21. The subject has active ulcerative colitis, Crohn's disease, celiac disease or any
    other conditions that interfere with absorption.
    22. The subject has had another active malignancy within the past five years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin. Questions regarding inclusion of individual subjects should be directed to the Abbott Medical Monitor.
    23. The subject has a medical condition, which in the opinion of the study investigator, places them at an unacceptably high risk for toxicities.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is progression free survival of the two treatment groups (ABT-869 + mFOLFOX6 versus bevacizumab + mFOLFOX6).
    The secondary endpoints of the study will be overall survival, 12-month survival rate, time to disease progression, objective response rate, best response rate, maximum percent reduction in tumor size, duration of response, as well as the safety and tolerability of the combination.

    The tertiary endpoints are quality of life and performance status.
    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 No
    E.6.7Pharmacodynamic No
    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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 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 months26
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months26
    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 2009-02-20. 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    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 Decision2009-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-07
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