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    Summary
    EudraCT Number:2013-003252-20
    Sponsor's Protocol Code Number:989
    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:2013-09-19
    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 number2013-003252-20
    A.3Full title of the trial
    An open-label, two-stage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladder
    Eine offene, zweistufige, Phase I/IIa-Dosiseskalationsstudie mit BT062 bei metastasiertem dreifach rezeptor-negativem Brustkrebs und bei metastasiertem Übergangszellkarzinom der Harnblase
    Étude en ouvert en deux parties de phase I/ IIA d’escalade de dose de BT062 chez des patients de cancer du sein métastatique triple récepteur négatif et dans le carcinome métastatique à cellules transitionnelles de la vessie urinaire
    Een open-label, fase I/IIa twee-staps dosisescalatiestudie van BT062 in gemetastaseerde drievoudig receptor-negatieve borstkanker en gemetastaseerde kanker van de overgangsepitheelcellen van de blaas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, two-stage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladder
    Eine offene, zweistufige, Phase I/IIa-Dosiseskalationsstudie mit BT062 bei metastasiertem dreifach rezeptor-negativem Brustkrebs und bei metastasiertem Übergangszellkarzinom der Harnblase
    Étude en ouvert en deux parties de phase I/ IIA d’escalade de dose de BT062 chez des patients de cancer du sein métastatique triple récepteur négatif et dans le carcinome métastatique à cellules transitionnelles de la vessie urinaire
    Een open-label, fase I/IIa twee-staps dosisescalatiestudie van BT062 in gemetastaseerde drievoudig receptor-negatieve borstkanker en gemetastaseerde kanker van de overgangsepitheelcellen van de blaas
    A.3.2Name or abbreviated title of the trial where available
    INTRAIN-BB (INdaTuximab RAvtansin effect IN Brest and Bladder cancer
    A.4.1Sponsor's protocol code number989
    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 SponsorBiotest AG
    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 supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotest AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLandsteinerstr.5
    B.5.3.2Town/ cityDreieich
    B.5.3.3Post code63303
    B.5.3.4CountryGermany
    B.5.4Telephone number+4961038019865
    B.5.5Fax number+496103801341
    B.5.6E-mail989@biotest.de
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/593
    D.3 Description of the IMP
    D.3.1Product nameIndatuximab ravtansine
    D.3.2Product code BT062
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNIndatuximab ravtansine
    D.3.9.3Other descriptive nameBT062
    D.3.9.4EV Substance CodeSUB126113
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    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 typeBT062 is a novel agent composed of the cytotoxic maytansinoid DM4, covalently linked to the naked BT062 (nBT062) monoclonal antibody. BT062 is an Antibody Drug Conjugate.
    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
    Subjects with metastatic triple receptor-negative breast cancer (TNBC) who failed at least 2 and no more than 4 prior chemotherapies or alternatively

    Subjects with metastatic transitional cell carcinoma (TCC) of the urinary bladder who failed at least 1 and no more than 2 prior chemotherapies.

    E.1.1.1Medical condition in easily understood language
    metastatic triple receptor-negative breast cancer or metastatic transitional cell carcinoma of the urinary bladder
    metastasierter dreifach rezeptor-negativer Brustkrebs oder metastasiertes Übergangszellkarzinom der Harnblase
    cancer du sein métastatique triple récepteur négatif ou carcinome métastatique à cellules transitionnelles de la vessie urinaire
    gemetastaseerde drievoudig receptor-negatieve borstkanker of gemetastaseerde kanker van de overgangsepitheelcellen van de blaas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10071664
    E.1.2Term Bladder transitional cell carcinoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I Part (Dose Escalation):To determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and the recommended Phase II dose (RPTD) of BT062 in patients with metastatic triple-negative breast cancer (TNBC) or metastatic transitional cell carcinoma of the urinary bladder ((TCCUB).

    Phase IIa Part (Cohort Expansion):To assess the proportion of patients experiencing disease control (SD, PR or CR) according to RECIST criteria during the first 3 treatment cycles.
    E.2.2Secondary objectives of the trial
    Phase I Part (Dose Escalation):
    - To assess the safety and tolerability profiles of BT062 in patients with metastatic TNBC or metastatic TCCUB;
    - To assess peak and through levels and a potential accumulation of BT062 after repeated dosing
    - To assess the proportion of patients experiencing disease control during the first 3 treatment cycles
    Phase IIa Part (Cohort Expansion):
    • To assess the safety and tolerability profiles of BT062;
    • To assess the frequency and duration of response categories;
    • To assess the Progression Free Survival time;
    • To assess Overall Survival Time
    • To determine main PK parameters of BT062 and free DM4 (Cmax, Tmax, AUC, t1 / 2, CL, V) in plasma after multiple doses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written Informed Consent Form in accordance with institutional guidelines and applicable national law, prior to any study-related procedure;
    2. Diagnosis:
    • metastatic triple-negative breast cancer with histochemical confirmation of the absence of progesterone receptors, estrogen receptors and human epidermal growth factor receptors
    or
    • metastatic transitional celll carcinoma of the urinary bladder
    3. Relapsed or relapsed / refractory disease at a stage that cannot be controlled adequately by surgery, radiotherapy or standard chemotherapy;
    3a: Patients presenting with triple negative breast cancer and who failed at least 2, but not more than 4 previous chemotherapy / drug therapy regimens. In patients who failed more than 2 prior chemotherapy / drug therapy regimens, the last progression of disease must not have been observed earlier than within 9 weeks of the start of the treatment.
    3b: Patients presenting with urinary bladder cancer and who failed at least 1, but not more than 2 previous chemotherapy regimens.
    4. Measurable disease according to the RECIST (v1.1) with at least one measurable lesion and at least one tumor biopsy with histologically confirmed malignancy;
    5. Histological confirmation of moderate to high CD138 expression for at least one lesion;
    6. Female or male patients aged > 18 years;
    7. Estimated life expectancy ≥ 12 weeks;
    8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2;
    9. Absolute neutrophil count (ANC) ≥ 1500 cells / µL;
    10. Hemoglobin (Hb) ≥ 9.0 g / dL;
    11. Platelet count ≥ 100,000 / µL at screening;
    12. Liver transaminases:
    • In patients without liver metastases: AST (SGOT) and ALT (SGPT) ≤ 3 times the upper limit of normal (ULN);
    • In patients with liver metastases: AST (SGOT) and ALT (SGPT) ≤ 5 times the ULN, provided that there is no evidence of other reasons for transaminase level increase,
    13. Total bilirubin ≤ 1.5 times the ULN;
    14. Lipase ≤ 3 times the ULN;
    15. Renal function:
    Serum creatinine ≤ 2 mg / dL; Creatinine clearance (CRCL) ≥ 50 mL / min;
    16. Ability to understand, and willingness to sign a written Informed Consent Form;
    17. Ability and willingness to adhere to the study visit schedule and all protocol procedures;
    18. Subjects must use two acceptable methods of birth control from the point of signing Informed Consent Form (ICF) until 3 months after administration of the last dose of study drug;
    19. Patients must agree not to donate blood from the point of signing the ICF until at least 1 month after administration of the last dose of the study drug;
    20. Negative serum or urine pregnancy test in female patients of childbearing potential.

    E.4Principal exclusion criteria
    1. History of allergy against study drug related components or drugs
    2. Administration of chemotherapy or radiotherapy within 3 weeks prior to day of first dose of study drug or during the study;
    3. Chemotherapy with nitrosoureas or mitomycin C within 6 weeks prior to day 1
    4. Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half-lifes (t½) prior to first dose, whichever time period is longer
    5. Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is longer.
    6. Treatment with BT062 in previous studies;
    7. Previous treatment with vinflunine;
    8. Planned tumor-reduction surgery and surgical removal of well accessible metastases;
    9. Anticipation of the need to apply radiotherapy during the first 3 cycles/12 weeks of the study.
    10. Major surgery within 4 weeks prior to Day 1;
    11. Persistence of clinically relevant symptoms of incomplete recovery from a previous major surgery;
    12. Malignancy (other than the trial indications) within the past three years except:
    • Treated non-melanoma skin cancer;
    • Carcinoma in-situ of the cervix uteri;
    • Prostate carcinoma (Gleason Grade ≤ 6) with stable prostate specific antigen (PSA) levels
    13. Active metastasis of the central nervous System
    14. In patients of the dose escalation part (first part) of the study: treatment with denosumab within 5 months before the first dose of BT062 and / or planned treatment with denosumab and time during the treatment with BT062.
    15. In patients in the phase II part of the study who are scheduled to continue an ongoing denosumab treatment as a concomitant medication during the BT062 regimen:
    a) treatment with denosumab that started less than 6 months before the first dose of BT062
    b) changes in the denosumab dose level of more than 33% in the monthly dose in the last 3 months.
    c) history of severe hypercalcemia or hypocalcemia (of any origin)
    d) history of severe hypokalemia or severe hyperkalemia (of any origin)
    e) history of osteonecrosis (of any origin)
    f) history of severe adverse reactions that were assessed as related to denosumab
    g) history of severe pain that was assessed as related to denosumab
    h) history of hypersensitivity reactions to denosumab or any of its excipients
    16. Acute or clinically relevant abnormalities in electrocardiogram (ECG);
    17. Significant cardiac disease(≤ 6 months prior to Day 1)
    18. Uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg),
    19. History of clinically significant drug or alcohol abuse or ongoing clinically significant alcohol or drug abuse;
    20. Unwillingness or inability to adhere to the requirements of the study;
    21. Serious psychiatric or any other medical condition (including laboratory abnormalities), that could interfere with treatment and puts the patient at an unacceptable risk;
    22. Subject is a pregnant or nursing woman or is considering becoming pregnant during the study
    23. Subject is a woman of childbearing potential (unless surgically sterile or post-menopausal > 52 weeks) who is not using two independent effective contraceptive methods during the study
    OR
    Subject is a man and is not vasectomized or is not using two independent effective contraceptive methods during the study
    E.5 End points
    E.5.1Primary end point(s)
    The endpoint of the phase I part is the identification of the recommended part II dose (RPTD).
    The doses of BT062 will be escalated / de-escalated in a stepwise manner to determine the MTD, and to accordingly determine the RPTD for the patient population of interest (classical “3+3” approach).
    Participants will be evaluated for dose-limiting toxicities (DLTs) and /or adverse events (AE). Their safety and tolerability data will be used to identify the maximum tolerated dose (MTD) and the recommended Phase II dose (RPTD) of BT062. The MTD is defined as the highest dose of BT062 at which less than 2 out of 6 subjects experience a DLT. The MTD will normally be used as the RPTD. Alternatively, a RPTD can also be defined at a lower dose level or without reaching the maximum administered dose (MAD).

    The endpoints of the Phase II part of the study is derived from the fraction of patients who show at least disease control or a better outcome at the tumor staging after 3 cycles of chemotherapy of BT062 at the RPTD.
    The two tumor entities (TNBC and TCCUB) will be studied independently in parallel.
    The first endpoint (part I) will consist of the observation whether or not at least 5 out of 18 patients experienced disease control or a better. The observation will be made independently in 18 patients with TNBC and again in 18 other patients with TCCUB.
    If sufficient anti-tumor activity is observed at the first endpoint the recruitment will be expanded in the respective tumor entity/s by an additional 15 patients.
    The second primary endpoint (part II) will consist of the observation whether or not at least 11 out of 33 patients experienced disease control or better. If 11 or more responses are observed out of the 33 patients there will be sufficient evidence to reject the null hypothesis that the disease control rate is 20% or lower in the respective tumor entity.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I part: Assessment of DLTs after first treatment cycle (28d)
    Phase II part: Assessment of tumor progression after 3 treatment cycles (84d)
    E.5.2Secondary end point(s)
    Phase I Part (Dose Escalation):
    To assess the proportion of patients experiencing disease control during the first 3 treatment cycles (according to RECIST v1.1. criteria)
    To assess the safety and tolerability profiles of BT062 in patients with metastatic TNBC or metastatic TCCUB.
    To assess peak and through levels and a potential accumulation of BT062 after repeated dosing.
    To assess the frequency and duration of response categories (DOR);
    To assess the progression-free survival (PFS) time;
    To assess the overall survival (OS)

    Phase IIa (Cohort Expansion):
    To assess the safety and tolerability profiles of BT062 in patients with metastatic TNBC or metastatic TCCUB.
    To assess the frequency and duration of response categories (DOR);
    To assess the progression-free survival (PFS) time;
    To assess the overall survival (OS)
    To determine main PK parameters of BT062 and free DM4 (Cmax, Tmax, AUC, t1 / 2, CL, V).in plasma after multiple doses.
    To assess potential immunogenicity of BT062 after repeated doses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability: From study start until 30 days after the last dose of BT062.
    Anti-tumor efficacy: Regular tumor staging every 3 cycles (90d)
    Peak and trough levels of BT062 in plasma: Every treatment day (day 1, 8, 15 of a 28d cycle)
    Detailed Pharmacokinetic parameters: Cycle 1 Day 1, Cycle 1 Day 15
    Progression free survival, Overall survival: long term follow-up contacts every 90 days if possible, Data cut off time point 1 year after start of treatment in the last patient
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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
    Pharmacokinetics after repeated dose
    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 Yes
    E.8.1.7.1Other trial design description
    Phase I / IIa study with initial dose-escalation phase, followed by a two-stage part
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    The trial ends one year after the last patient started treatment or when the last patient is lost to follow up or deceases, whatever occurs earlier. Data up to this timepoint included in the clinical study report. However, if patients continue to experience disease control and adequate tolerability, they may continue to receive the study drug for an undefined period of time, also beyond this time point.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    Any treatment of patients having completed the trial (prematurely or not) will be at the discretion of the responsible physician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-04
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