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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-005116-28
    Sponsor's Protocol Code Number:38495
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-005116-28
    A.3Full title of the trial
    A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.
    The ReCab trial
    Een studie van combinatie van Rhenium-188-HEDP en Cabazitaxel in patiënten met naar het bot uitgezaaide prostaatkanker die onvoldoende reageren op hormonale controle en Docetaxel: de ReCab 1 studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I/II trial of Cabazitaxel +/- Rhenium-188 HEDP in patients with metastatic castration resistant prostate cancer who progressed on or after a docetaxel containing treatment.
    The ReCab trial
    Een studie van combinatie van Rhenium-188-HEDP en Cabazitaxel in patiënten met naar het bot uitgezaaide prostaatkanker die onvoldoende reageren op hormonale controle en Docetaxel: de ReCab 1 studie
    A.3.2Name or abbreviated title of the trial where available
    ReCab trial
    ReCab sudie
    A.4.1Sponsor's protocol code number38495
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Cabazitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    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.3.1Product nameCabazitaxel
    D.3.2Product code XRP6258
    D.3.4Pharmaceutical form 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 INNJevtana
    D.3.9.1CAS number 183133-96-2
    D.3.9.2Current sponsor codeXRP6258
    D.3.9.3Other descriptive nameCABAZITAXEL
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    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) 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
    Metastatic prostate cancer/bone metastases
    Uitgezaaide prostaatkanker met botuitzaaiingen
    E.1.1.1Medical condition in easily understood language
    metastatic prostate cancer
    uitgezaaide prostaatkanker
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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
    Primary objectives:
    To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with cabazitaxel in order to proceed with a Randomized Phase 2 trial designed to determine the clinical value of Rhenium-188 HEDP/cabazitaxel using overall survival as the primary endpoint. Patients included in the phase1 part with the dose schedule selected for the phase 2 part will be integrated in the final phase 2 analysis.
    Onderzoeken van veiligheid en effeciviteit van de combinatie van rhenium-188-HEDP en cabazitaxel in een dosis escalatie studie, gevolgd door een gerandomiseerde fase 2 studie
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    Evaluate time to progression, clinical benefit response and toxicity
    tijd tot ziekte progressie, klinisch effect, response en toxiciteit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • mCRPC patients with documented disease progression;
    - If measureable: (RECIST) progression
    - If non-measurable: documented rising PSA levels (at least 2 consecutive rises in PSA over a reference value taken at least 1 week apart) or appearance of new lesion
    • Previous treatment with a docetaxel-containing regimen
    • WHO performance status 0 or 1.
    • Life expectancy of at least 3 months.
    • Age > 18years.
    • Adequate renal function defined as serum creatinin ≤ 1.5 x ULN and/or calculated creatinin clearance 50ml/min
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x
    109/L
    • Total bilirubin ≤ 1 x ULN, ALT, AST ≤ 2.5 x ULN
    • Alkaline phosphatase < 10 x ULN.
    • Absence of any psychological, familial, sociological or geographical
    condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    • Written informed consent
    • Bone metastases must show uptake of Tc-99m-HDP on bone
    scintigraphy
    • Adequate hematological function defined as: Haemoglobin > 9 g/dl;
    Total White cell count >4.0 x 109/l; Platelet count >100 x 109/l.
    • Patients under LH-RH agonists must continue their treatment.
    • Prior hormonal therapy for prostate cancer, resulting in serum testosterone < 50ng/dl
    Hormoon en docetaxel resistent prostaatcarcinoom.
    E.4Principal exclusion criteria
    • Previous exposure to combined Rhenium -188- HEDP and docetaxel treatment.
    • Active uncontrolled bacterial, viral or fungal infection.
    • History of another malignancy within the last five years except adequately treated basal cell carcinoma of skin.
    • Organ allografts requiring immunosuppressive therapy.
    • Serious uncontrolled concomitant disease.
    eerdere behandeling met combinaie van rhenium-188-HEDP en docetaxel
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    Dose Limiting Toxicity (DLT) is defined as any grade 4 toxicity lasting >7 days, or any grade 3 toxicity which does not recover within 10 days. If a DLT occurs in 1 of the 3 patients in a particular treatment level, the group will be expanded to 6 patients. If 2 or more of the group experience a DLT, we will treat the next 3 patients at the previous dose level (i.e. If DLT in >2/6 at dose level 2, 3 patients will be treated at dose level 1. If none of the group of 3 or <1/6 experience DLT, 3 patients will be treated at the next dose level. The final group of 3 patients will be treated at a planned dose of 6 cycles of cabazitaxel 25mg/m2 and 2 cycles of Rhenium-188 HEDP (40 MBq/kg).
    Phase II:
    Efficacy Parameters
    TTP (time to progression ) will be the primary efficacy endpoint.
    Furthermore, PSA, and clinical benefit response (Skeletal Related Events, Qol, Pain and Palliative Medication). .
    Safety Parameters:
    Adverse events and clinical laboratory parameters including hematology (complete blood counts including differential and platelets), survival. NCI toxicity criteria will be followed.
    dosis limiterende toxiciteit (fase 1).

    Tijd tot ziekte progressie (fase 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of studie
    einde van studie
    E.5.2Secondary end point(s)
    toxicity and progression of disease
    toxiciteit en ziekte progressie
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the study
    gedurende de studie
    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 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) 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
    phase I: Combination of two drugs that are both extensively studied in previous trials
    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 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 Yes
    E.8.2.3.1Comparator description
    rhenium-188-HEDP met cabzitaxel versus cabazitaxel alleen
    rhenium-188-HEDP + cabazitaxel versus cabazitaxel alone
    E.8.2.4Number of treatment arms in the trial45
    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 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
    last visit
    Laaste controle
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    F.2 Gender
    F.2.1Female No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 care
    standaard behandeling
    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 Decision2012-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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