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    Summary
    EudraCT Number:2013-005504-34
    Sponsor's Protocol Code Number:C-II-010
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-03
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-005504-34
    A.3Full title of the trial
    Randomized phase II CAbazitaxel dose Individualization and Neutropenia prevention TriAl (CAINTA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase II CAbazitaxel dose Individualization and Neutropenia prevention TriAl (CAINTA)
    A.4.1Sponsor's protocol code numberC-II-010
    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 SponsorCESAR Central European Society for Anticancer Drug Research - EWIV
    B.1.3.4CountryAustria
    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 supportSanofi-Aventis
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCESAR Central European Society for Anticancer Drug Research - EWIV
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressHanglüssgasse 4/1-3
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1150
    B.5.3.4CountryAustria
    B.5.6E-mailoffice@cesar.or.at
    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 Jevtana®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameJevtana®
    D.3.4Pharmaceutical form Concentrate 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 INNcabazitaxel acetone solvate
    D.3.9.1CAS number 183133-96-2
    D.3.9.2Current sponsor codeRPR116258A
    D.3.9.3Other descriptive nameCABAZITAXEL
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Stage II with advanced Castration-Resistant Prostate Cancer (CRPC)
    E.1.1.1Medical condition in easily understood language
    castration-resistant metastatic prostate 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
    The primary objective of the CAINTA study is to apply individualized cabazitaxel dosing in patients with advanced CRPC. By applying the prespecified dosing algorithm in the experimental treatment group (Arm B), the clinical feasibility rate is expected to increase from 40% in the conventional treatment Arm A to 75% in the experimental treatment Arm B (all toxicity grading according to the CTCAE version 4.0). Clinical feasibility is defined as the absence of any of the following criteria: Grade 4 neutropenia, grade 4 thrombocytopenia, thrombocytopenia of any grade with bleeding, febrile neutropenia, grade 3-4 non-hematological toxicity, withdrawal due to cabazitaxel-related toxicity or death. At the same time, progression-free survival (PFS) and overall survival (OS) must not be affected by individualized dosing of cabazitaxel.
    E.2.2Secondary objectives of the trial
    •PSA-response in patients with a baseline PSA-value of 20 μg/L, defined as a 50% decline of PSA and best PSA Response
    •Time to PSA-progression, defined as an increase of PSA by ≥ 25% from the nadir and an absolute increase of ≥ 5 ng/mL from the nadir
    •Tumor response acc. to the RECIST v.1.1
    •All AEs will be ass. acc. to the NCI CTCAE v.4.0 crit.until 30 days after study treatment with cabazitaxel ended
    •The rate of severe (grade 3 and 4, acco. to the RECIST v.1.1 crit.) neutropenia until 30 days after study treat. with cabazitaxel ended
    •Progression-free survival (PFS), defined as follows: Time from registration until one of the following events (whichever occurs first):
    -Progression assessment acco. to the RECIST criteria
    -Death of any cause
    •Overall survival (OS) and survival rate after 6,12 and 18 months
    •Area-under-the concentration-time curve (AUC) of cabazitaxel from the final population pharmac. model
    •Quality-of-life according to the EORTC QLQ-C30 questionnaire
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The primary objective of this subproject is the exploratory analysis of cabazitaxel pathway-associated gene polymorphisms in study patients, and compare potential germline polymorphism DNA mutations with clinical outcome, i.e. treatment activity and adverse events.
    •Which genes differentiate patients experiencing severe neutropenia from those experiencing mild neutropenia
    •Which genes differentiate chemotherapy (cabazitaxel) responders from non-responders
    •Which genes differentiate patients with a short progression-free survival from those with a long progression-free survival
    •Which genes differentiate patients with severe treatment-associated toxicity from those with no or mild treatment-associated toxicity
    •Which genes differentiate patients with a short overall survival from those with a long overall survival
    E.3Principal inclusion criteria
    (1)Capable of understanding the protocol requirements and risks, and providing written informed consent.
    (2)Patients with histologically or cytologically proven, castration-resistant prostate adenocarcinoma, that progressed during or after completion of previous docetaxel treatment.
    (3)Patients with a formal indication for monotherapy with IV cabazitaxel at 3-weekly cycles.
    (4)Measurable or non-measurable (evaluable) disease according to the RECIST criteria, version 1.1.
    (5)ECOG Performance Status (ECOG-PS) status 0-2.
    (6)Male patients at least 18 years of age at randomization.
    (7)Patients have received prior castration by orchiectomy and/or a Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist with or without antiandrogens, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents (antiandrogen treatment is continued during study treatment).
    (8)Patients may also having received prior abiraterone acetate, TAK700 or enzalutamide.
    (9)Sexually active men must use acceptable contraceptive methods (condom).
    (10)Patients suffering from asymptomatic brain metastases can be enrolled in case corticosteroid therapy is not indicated. Prior irradiation must be completed at least 2 week prior to initiating cabazitaxel chemotherapy within the study.
    E.4Principal exclusion criteria
    (1)Previous treatment with cabazitaxel.
    (2)Prior isotope therapy or radiotherapy to ≥30% of the bone marrow.
    (3)Adverse events grade >1 (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy at the time of randomization.
    (4)Prior malignancy. Adequately treated basal-cell or squamous-cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed ≥ 5 years ago and from which the patient has been disease-free for ≥ 5 years.
    (5)Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
    (6)Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
    (7)Inadequate organ and bone marrow function as evidenced by:
    a.Hemoglobin <10.0 g/dL
    b.Absolute neutrophil count <1.5•109/L
    c.Platelet count <100•109/L
    d.AST/SGOT and/or LT/SGPT >1.5•ULN (>5•ULN in case of liver metastases)
    e.Total bilirubin >1.0•ULN (>2.5•ULN in case of liver metastases)
    f.Serum creatinine >1.5•ULN. If creatinine 1.0-1.5xULN, creatinine clearance will be calculated according to the CKD-EPI formula and patients with creatinine clearance <60ml/min are excluded
    (8)Other concurrent serious illness or medical conditions
    (9)Any severe acute or chronic medical condition (e.g. active infection, severe heart disease, uncontrolled hypertension or diabetes mellitus) that could impair the ability of the patient to participate to the study, or to comply with the study procedures or interfere with interpretation of study results.
    (10)History of severe hypersensitivity reaction (CTC grade ≥3) to taxanes or polysorbate 80 containing drugs
    (11)Contraindications to the use of corticosteroid treatment
    (12)Symptomatic peripheral neuropathy grade >2
    (13)Treatment with cytotoxic or biologic agents or any experimental drug within the 2 weeks prior to beginning treatment on this study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the present protocol is the clinical feasibility rate, defined as the absence of any of the following criteria: Grade 4 neutropenia, grade 4 thrombocytopenia, thrombocytopenia of any grade with bleeding, febrile neutropenia, grade 3-4 non-hematological toxicity, withdrawal due to cabazitaxel-related toxicity or death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    the occurance of one the above mentioned criteria
    E.5.2Secondary end point(s)
    •PSA-response in patients with a baseline PSA-value of ≥20 μg/L [14], defined as a ≥50% decline of PSA and best PSA response
    •Time to PSA-progression, defined as an increase of PSA by ≥ 25% from the nadir and an absolute increase of ≥ 5 ng/mL from the nadir
    •Tumor response according to the RECIST v.1.1 criteria
    •All AEs will be assessed according to the NCI CTCAE v.4.0 criteria until 30 days after study treatment with cabazitaxel ended
    •The rate of severe (grade 3 and 4, according to the RECIST v.1.1 criteria) neutropenia until 30 days after study treatment with cabazitaxel ended
    •Progression-free survival (PFS), defined as follows: Time from registration until one of the following events (whichever occurs first):
    -Progression assessed according to the RECIST criteria
    -Death of any cause
    •Overall survival (OS) and survival rate after 6,12 and 18 months
    •Area-under-the concentration-time curve (AUC) of cabazitaxel from the final population pharmacokinetic model
    •Quality-of-life according to the EORTC QLQ-C30 questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    the occurance of one the above mentioned criteria
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    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
    Control Group
    E.8.2.4Number of treatment arms in the trial2
    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 EEA8
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Germany
    Switzerland
    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 database will be closed 8 months following the enrollmentt of the last Patient. After completion of the Treatment Phase, patients will enter into an observational follow-up (F/U) phase until death, lost to follow-up or the Overall study end. Therefore. the end of the Trial cannot be "last visit of the last subject undergoing the Trial".
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 72
    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)
    Individual patients will receive treatment on study until the completion of 6 cycles, until tumor progression/until intolerable toxicity, whichever comes first. Afterwards they remain in an observation follow-up phase until death, lost to follow-up or study closure. Patients receive medical care according to the discretion of the treating physician, but not in the context of this clinical study.
    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 Decision2014-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-27
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