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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-002036-24
    Sponsor's Protocol Code Number:Uni-koeln-1612
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-30
    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 number2013-002036-24
    A.3Full title of the trial
    A non-randomised, non-comparative monocenter investigator initiated trial to assess the efficacy and safety of Carmustine in patients with BRCA1/2-associated advanced breast and ovarian cancer

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of advanced breast- and ovarian cancer which are refractory to standard therapy and for which no suitable, effective/curative therapy exists.
    A.3.2Name or abbreviated title of the trial where available
    ADCARE
    A.4.1Sponsor's protocol code numberUni-koeln-1612
    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 SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    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 supportMedical Faculty of the University of Cologne
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter of Familial Breast and Ovarian Cancer
    B.5.2Functional name of contact pointAdCare
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Strasse 62
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number+4922147886509
    B.5.5Fax number+4922147886510
    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 Yes
    D.2.1.1.1Trade name Carmubris
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Powder and solvent for 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 INNCARMUSTINE
    D.3.9.1CAS number 154-93-8
    D.3.9.4EV Substance CodeSUB06132MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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) 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 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
    Patients with BRCA1- or BRCA2-associated advanced breast- and ovarian cancer which are refractory to standard therapy and for which no suitable, effective/curative therapy exists.
    E.1.1.1Medical condition in easily understood language
    Advanced breast- and ovarian cancer which are refractory to standard therapy and for which no suitable, effective/curative therapy exists
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Tumor response (i.e. non-progressive disease) after 2 and 4 cycles of chemotherapy / at week 12 and 24 (assessed using the principles of RECIST 1.1, based on confirmed response)
    E.2.2Secondary objectives of the trial
    Tumor response (OR) after 6 cycles of chemotherapy /at week 36, PFS, OS, DOR and DCR, health-related quality of life (EORTC QLQ C30 and EQ-5D), ECOG Performance Status
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female BRCA1 and BRCA2 mutation carriers
    • Histological confirmed breast or ovarian cancer
    • Refractory to standard therapies and for which no suitable effective standard therapy exists
    • Age ≥18 years
    • ECOG 0-2 with adequate cardiac, bone marrow (platelet count >/= 100x109/l), hepatic (total bilirubin </=1.5 x institutional upper limit of normal (ULN); ASAT/ALT </= 2.5 x institutional ULN unless liver metastases are present in which case it must be </= 5 x ULN) and renal function
    • Patients must have a life expectancy >/= 3 months
    • Postmenopausal or use of adequate contraceptive during chemotherapy and six months thereafter
    • Fully informed consent prior to study-specific procedures
    • Patient is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
    • At least one lesion (measurable and/or non-measurable) at baseline that can be accurately assessed by CT/MRI and is suitable for repeated assessment at follow-up visits
    • All baseline radiological tumour assessments must be performed no earlier than 21 days before start of the study treatment.
    E.4Principal exclusion criteria
    • Pregnant or nursing patients
    • Prior chemotherapy with nitroso-urea substances for any malignancy
    • Concurrent treatment with other experimental drugs or any other anti-cancer therapy
    • Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons) within 2 weeks from the last dose prior to study treatment.
    • Nicotine abuse
    • Limited pulmonary function
    • Pre-existing pulmonary diseases (e.g. chronic obstructive pulmonary disease/COPD, fibrosis)
    • Prior radiation including areas of the lung (except radiation of the breast after breast conserving surgery).
    • Pre-existing radiographical alterations of the lung
    • Any psychological, sociological or geographical condition potentially impeding compliance with study protocol or follow-up
    • Known or suspected allergy to the BCNU
    • Failure to use highly-effective contraceptive
    • Persistent toxicities (>CTCAE grade 2) caused by previous therapies
    E.5 End points
    E.5.1Primary end point(s)
    Tumor response (i.e. non-progressive disease) after 2 and 4 cycles of chemotherapy / at week 12 and 24 (assessed using the principles of RECIST 1.1, based on confirmed response)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 and 24 weeks (2 and 4 cycles) of chemotherapy
    E.5.2Secondary end point(s)
    Secondary objective is the efficacy of the treatment measured by tumor response after 6 cycles of chemotherapy /at week 36 (assessed by OR, PFS, OS, DOR and DCR, health-related quality of life (EORTC QLQ C30 and EQ-5D), ECOG Performance Status).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 36 weeks (6 cycles) of chemotherapy
    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 No
    E.6.7Pharmacodynamic No
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    42 days after LPLV
    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 months6
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 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 state10
    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)
    Best palliative 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 Decision2014-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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