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    The EU Clinical Trials Register currently displays   38185   clinical trials with a EudraCT protocol, of which   6272   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2011-002576-16
    Sponsor's Protocol Code Number:GINECO-EN102b
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-04
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2011-002576-16
    A.3Full title of the trial
    Phase 2 multicenter study to assess the safety and efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line therapy in patients who cannot undergo local surgery and/or radiotherapy.
    Etude multicentrique de phase 2 évaluant la tolérance et l’efficacité du BKM120 en monothérapie dans le cancer de l’endomètre métastatique d’emblée ou en rechute après une première ligne, chez des patientes ne pouvant être traitées avec une chirurgie locale et/ou une radiothérapie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude multicentrique de phase 2 évaluant la tolérance et l’efficacité du BKM120 en monothérapie dans le cancer de l’endomètre métastatique d’emblée ou en rechute après une première ligne, chez des patientes ne pouvant être traitées avec une chirurgie locale et/ou une radiothérapie.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberGINECO-EN102b
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorARCAGY
    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 supportARCAGY
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARCAGY
    B.5.2Functional name of contact pointSponsor office
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Hôtel-Dieu, 1, place du Parvis Notre-Dame
    B.5.3.2Town/ cityParis cedex 4
    B.5.3.3Post code75181
    B.5.4Telephone number33142348323
    B.5.5Fax number33143262673
    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.3.2Product code BKM120
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    initial or recurrent metastatic endometrial cancer after first line therapy in patients who cannot undergo local surgery and/or radiotherapy.
    E.1.1.1Medical condition in easily understood language
    metastatic endometrial cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemiotherapy.
    Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending on the group of patients. The primary endpoint is the non-progression rate at 3 months (12 weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive disease (high grade tumor = stratum 2).
    E.2.2Secondary objectives of the trial
    • safety and tolerance
    • progression-free survival at 6 months
    • objective response rate
    • duration of response.
    • overall survival.

    • mutational status of PIK3CA, PIK3R1, KRAS, BRAF, ß-catenine, AKT and PTEN genes on archived tumor block.
    • PTEN, AKT, TSC2, EUH, LE PR, pS6, pAKT, HER2 and LKB1 gene expression on archived tumor block.
    • amplified genes (including, for example: PIK3CA, PIK3CB, PTEN, TSC2, AKT, LKB1 genes) on archived tumor block
    • changes in biomarkers (e.g. p-AKT, p-S6, p-4EBP1) before and after treatment on recent tumor biopsies (if available).
    • To correlate the molecular anomalies observed and the efficacy of BKM120.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female ≥ 18 years old.
    • ECOG performance index 0-2.
    • Patient with histological confirmed endometrial cancer.
    • Patient who is not eligible for exclusive curative treatment by surgery and/or radiotherapy.
    • Patient with initial metastatic endometrial cancer that has not been treated with chemotherapy or radiotherapy prior to inclusion
    Patient with recurrent endometrial cancer previously treated with adjuvant chemotherapy and radiotherapy, presenting with a disease-free interval (period between the date of the last dose of chemotherapy and relapse) of at least 12 months.
    • Presence of one or more measurable lesion(s) outside the irradiated areas.
    • Availability at the time of inclusion of samples of tumor tissue, in the form of archived tissue (a block or at least 20 unstained slides) for tumor sub-classification (low grade = stratum 1; high grade = stratum 2) and for routine molecular analysis.
    • Satisfactory biological functions
    • Life expectancy 3 months.
    • The Information Consent Form (ICF) must be signed by the patient before any procedure is carried out.
    E.4Principal exclusion criteria
    • Previous treatment with PI3K inhibitors and/or mTOR.
    • Presence of symptomatic central nervous system (CNS) metastases.
    • Concomitant presence or history of another malignant tumor in the past 3 years prior to inclusion in the study (with the exception of spinocellular or cutaneous basal cell epithelioma or non-melanomatous skin cancer treated successfully).
    • Patient suffering from one of the following mood disorders based on an evaluation by the investigator or a psychiatrist OR with a limit score of ≥ 10 on the PHQ-9 (Patient Health Questionnaire) OR a limit score of ≥ 15 on the GAD-7 mood evaluation scale, respectively, OR with a positive response of "1, 2, or 3" to question number 9 relating to suicidal ideation in the PHQ-9 questionnaire (regardless of the overall score obtained in PHQ-9).
    o Medically documented earlier or active major depressive episodes, bipolar disorders (I or II), compulsive obsessive disorders, schizophrenia, history of suicide attempts or suicidal ideation or homicidal ideation (immediate risk of harming another person).
    o Anxiety ≥ grade 3 CTCAE
    • Concomitant administration of another approved or investigational anticancer agent (hormonal agents included).
    • Pelvic and/or para-aortic radiotherapy within ≤ 28 days prior to inclusion in the study or persistent side effects from this treatment on implementation of the selection procedures.
    • Major surgery during the 28 days prior to starting the investigational drug or persistent side effects from surgery.
    • Uncontrolled diabetes (HbA1c > 8 %).
    • Presence of an active heart disease
    • History of heart disease
    • Currently receiving treatment to prolong the QT interval accompanied by a known risk of triggering wave burst arrhythmia.
    • Gastrointestinal dysfunction (GI) or gastrointestinal disease (GD) that could significantly interfere with absorption of BKM120.
    • Chronic treatment with corticosteroids or other immunosuppressants.
    • Any other severe and/or uncontrolled concomitant disease
    • Currently receiving treatment known to be inhibitors or moderate and strong inducers of isoenzyme CYP3A.
    • Severe pneumonitis.
    • Grade ≥ 3 biological anomalies.
    • Known history of HIV infection.
    • Pregnant woman or nursing mother
    • Woman of child-bearing potential must use highly effective contraception and must have a negative serum pregnancy test ≤ 72 hours prior to initiating treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Non-progression rate according to RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 (stratum 1) or 2 months (stratum 2)
    E.5.2Secondary end point(s)
    -Safety according to CTCAE v4.0 criteria and mood questionnaires : PHQ-9 and GAD-7
    -PFS at 6 months
    -ORR according to RECIST 1.1
    -Duration of response
    -Overall Survival
    - Exploratory
    E.5.2.1Timepoint(s) of evaluation of this end point
    during all the time of the study
    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 No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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.8.2.4Number of treatment arms in the trial1
    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 concerned20
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    12 months after the last follow up visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state56
    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)
    standard of care
    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 Decision2011-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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