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    The EU Clinical Trials Register currently displays   41188   clinical trials with a EudraCT protocol, of which   6742   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-014796-51
    Sponsor's Protocol Code Number:120BC201
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-014796-51
    A.3Full title of the trial
    Phase 2a, open-label, randomized, noncomparative study of BIIB021 in combination with exemestane in women with hormone receptor-positive, advanced metatatic breast cancer who have progressed on a nonsteroidal aromatase inhibitor
    A.4.1Sponsor's protocol code number120BC201
    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 SponsorBiogen Idec Ltd.
    B.1.3.4CountryUnited Kingdom
    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 nameSynthetic, small molecule, heat shock protein 90 (Hsp90) inhibitor
    D.3.2Product code BIIB021
    D.3.4Pharmaceutical form Capsule*
    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.3.9.3Other descriptive nameBIIB021
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic, small molecule, heat shock protein 90 (Hsp90) inhibitor
    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 nameSynthetic, small molecule, heat shock protein 90 (Hsp90) inhibitor
    D.3.2Product code BIIB021
    D.3.4Pharmaceutical form Capsule*
    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.3.9.3Other descriptive nameBIIB021
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic, small molecule, heat shock protein 90 (Hsp90) inhibitor
    D.IMP: 3
    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 nameSynthetic, small molecule, heat shock protein 90 (Hsp90) inhibitor
    D.3.2Product code BIIB021
    D.3.4Pharmaceutical form Capsule*
    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.3.9.3Other descriptive nameBIIB021
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic, small molecule, heat shock protein 90 (Hsp90) inhibitor
    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 Metastatic Breast Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of enrollment or at the timepoint specified in the individual eligibility criterion listed:
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Age ≥18 years at the time of informed consent or the age of consent in accordance with national regulations, whichever is higher.
    3. Must have histologically or cytologically confirmed estrogen receptor-positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer.
    • If available, pre-existing formalin-fixed and paraffin-embedded (FFPE) tumor tissue must be submitted to Biogen Idec before study completion, but not necessarily prior to enrollment (see Study Reference Manual).
    4. Must have disease progression during treatment with a nonsteroidal AI for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting.
    5. Must be a postmenopausal female defined as ≥60 years old, OR age ≥45 years with amenorrhea for ≥12 months with an intact uterus AND follicle stimulating hormone levels within postmenopausal range, OR prior bilateral oophorectomy.
    6. Expected survival time of at least 3 months in the opinion of the Investigator.
    7. Must have measurable or evaluable disease.
    • Measurable disease is defined as ≥1 lesion with a diameter of ≥10 mm (lesion must be measurable in ≥1 dimension, with the longest diameter to be recorded). See Section 13.1.1 for details.
    • Evaluable disease is defined as bone lesions evaluable by plain X ray, CT scan, or MRI. Lesions identified only by radionuclide bone scan are not allowed.
    • The target lesion(s) must not have been previously irradiated (newly arising lesions in previously irradiated areas are acceptable).
    • The following are not considered measurable or evaluable disease: leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast cancer, lymphangitis cutis/pulmonitis, cystic lesions, and abdominal masses that cannot be reproducibly measured and followed by CT or MRI.
    8. One prior chemotherapy regimen for advanced metastatic breast cancer is allowed. Must be at least 2 weeks since final treatment, and the subject must be recovered to baseline or ≤Grade 1 toxicity from prior treatment.
    • Prior chemotherapy in the adjuvant and/or neoadjuvant setting is allowed.
    9. Prior radiotherapy is allowed. Must be at least 2 weeks since treatment and the subject must be recovered to baseline or ≤ Grade 1 toxicity from prior treatment. Exceptions are as follows:
    • Strontium 90 (or other radiopharmaceutical) within previous 3 months is not allowed.
    • Sites of measurable disease must be outside the radiotherapy port.
    10. If the subject is taking bisphosphonates for bone metastases, bisphosphonate therapy must be established for at least 3 months. Concurrent initiation of bisphosphonates will be allowed if the subject has soft tissue or visceral metastases as the measurable or evaluable target lesion.
    11. Must be able to swallow and retain oral medication.
    12. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 (Appendix A).
    13. Required laboratory values:
    • ANC ≥1 × 103 cells/mm3, platelet count 75 × 103 cells/mm3, hemoglobin ≥90 g/L (≥9 g/dL).
    • Bilirubin ≤3 x upper limit of normal (ULN) (unless due to Gilbert’s syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 ≥ULN.
    • Serum creatinine ≤177 μmol/L (≤2.0 mg/dL).
    • International Normalized Ratio (INR)≤1.5, except in subjects who are currently on anti coagulation therapy and their most recent thrombotic event occurred >3 months prior to Day 1, then INR≤3.5.
    • Glucose ≥3.3 mmol/L (≥60 mg/dL), sodium ≥130 mmol/L, calcium ≥2.0 mmol/L (≥8 mg/dL).
    • Plasma cortisol and adrenocorticotropic hormone (ACTH) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency.
    14. Electrocardiogram (ECG) with QTc of ≤470 msec and no clinically significant findings.
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment or at the timepoint specified in the individual criterion listed:
    1. HER2 overexpressing tumor (immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization [FISH]+).
    2. Life-threatening metastatic visceral disease.
    3. History of central nervous system (CNS) metastasis.
    4. History of prior malignancies within the past 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix.
    5. Previous treatment with exemestane.
    6. Previous treatment with an Hsp90 inhibitor.
    7. Other concurrent hormonal therapy except for the following: steroids for adrenal failure, hormones for nondisease-related conditions (i.e., insulin for diabetes or Synthroid® for hypothyroidism), intermittent dexamethasone as an antiemetic.
    8. Use of medications that may affect the metabolism of BIIB021 within 14 days of the first dose of study treatment
    9. Use of medications that may affect the metabolism of exemestane, such as potent inducers of cytochrome p450 3A4 (CYP3A4), within 14 days of the first dose of study treatment
    10. Use of proton pump inhibitors within 7 days of the first dose of study treatment. H2 antagonists, except cimetidine, will be allowed.
    11. Active bacterial or viral infection requiring concurrent treatment.
    12. Known history of or positive test result for hepatitis B or C.
    13. Known history of or positive test result for human immunodeficiency virus (HIV).
    14. Uncontrolled, severe medical illness, which in the opinion of the Investigator and/or Sponsor could compromise protocol objectives.
    15. History of gastrectomy or major surgery to small intestine.
    16. Chronic diarrhea (excess of 2 to 3 stools/day above normal frequency).
    17. Major surgery within 28 days of first study treatment.
    18. Conditions that may predispose subjects to seizures:
    • History of seizure, previous significant head trauma (e.g., associated with loss of consciousness for more than 5 minutes), abrupt discontinuation of benzodiazepines, or use of potentially epileptogenic medications
    19. Drug or alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is progression-free survival (PFS), which is defined as the time interval from the date of randomization until disease progression or death, whichever occurs first.
    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 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 No
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Non-comparative
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Literature
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 end of study is defined as the date of the last clinic visit for the last subject
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 53
    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)
    In accordance with section 10.6 of the study protocol
    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 Decision2009-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-31
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