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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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).

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    Summary
    EudraCT Number:2015-000270-36
    Sponsor's Protocol Code Number:AbiCab
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2015-000270-36
    A.3Full title of the trial
    A randomized Phase II, open label multicenter cross-over study, to evaluate biomarkers, in 2nd line treatment of metastatic Castration Resistant Prostate Cancer (mCRPC) with abiraterone and cabazitaxel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized Phase II, open label multicenter cross-over study, to evaluate biomarkers, in 2nd line treatment of metastatic Castration Resistant Prostate Cancer (mCRPC) with abiraterone and cabazitaxel
    A.3.2Name or abbreviated title of the trial where available
    AbiCab
    A.4.1Sponsor's protocol code numberAbiCab
    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 SponsorUmeå University Hospital
    B.1.3.4CountrySweden
    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
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportStiftelsen för Strategisk Forskning,
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmeå University Hospital
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of oncology
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post codeSE-90185
    B.5.3.4CountrySweden
    B.5.6E-mailcamilla.thellenberg@onkologi.umu.se
    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 Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameZYTIGA 250 mg tabletter
    D.3.4Pharmaceutical form Tablet
    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.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.IMP: 2
    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 groupe
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 60 mg koncentrat och vätska till infusionsvätska, lösning
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.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 Castration Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Metastatic Castration Resistant Prostate Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate 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
    The primary objective is to evaluate if tumor expression levels of the biomarker AKR1C3 can predict mCRPC patient PSA response to therapy with abiraterone or cabazitaxel, during the first treatment period.
    E.2.2Secondary objectives of the trial
    I. To evaluate if tumor expression levels of the biomarker AR-V7 can predict mCRPC patient PSA response to therapy with abiraterone or cabazitaxel, during the first treatment period.
    II. Investigate if baseline tumor expression levels of AR-V7 and AKR1C3 can be used to select what sequence of treatment (abi+cab vs cab+abi) is most likely to result in successful treatment.
    III. Investigate if treatment with abiraterone and or cabazitaxel result in different resistance mechanisms with respect to induction of AR splice variants or other resistance mechanisms.
    IV. Validate tissue markers in bloodbased entities (“liquid biopsies”) such as Exosomes, Trombocytes and Circulating Tumor Cells (CTCs).
    V. Comparison of PSA progression free survival, Radiologic progression free survival in relation to assigned first treatment according to biomarker status and overall survival in relation to both treatment periods according to biomarker status.
    VI. Safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent
    2. Histological confirmed prostate cancer
    3. Macroscopic metastatic disease previous treated with docetaxel
    4. Castration resistant disease defined as:
    a) Plasma testosterone (< 0.5 ng/ml) and
    b) Increase in measurable disease (Recist 1.1) Or
    c) Appearance of new lesions on bone scintigrams Or
    d) Rising PSA, two consecutive rising values at least one week apart.
    5. Metastatic tumour containing biopsy (Crista iliaca or CT/Ultrasound-guided biopsy)
    E.4Principal exclusion criteria
    1. Less than 4 weeks since prior treatment with chemotherapy,
    2. Less than 4 weeks days since radiotherapy or surgery to the start, bone pain palliative radiotherapy is allowed
    3. Less than 4 weeks after stopping endocrine therapies including anti-androgen.
    4. No “new drugs” (ie abiraterone, enxalutamide, Ra223 and other) given in mCRPC stage will be allowed to ensure that the trial is strictly second line after Docetaxel.
    5. Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria)
    6. Use of other investigational drug therapy for any reason is prohibited.
    7. Persistent adverse events from previous cancer therapies > grade 1 (NCI CTCAE V4.03) with the exception of alopecia. (With respect to nail changes grade 2 is acceptable)
    8. Symptomatic peripheral neuropathy grade >2 (NCI CTCAE] v.4.03.
    9. Age less than 18 years
    10. ECOG performance status > 2
    11. Known CNS malignancy
    12. Within 6 months of randomization: myocardial infarction , unstable angina, angioplasty, bypass surgery, stroke, TIA, or congestive heart failure NYHA class III or IV
    13. Within 3 months prior to randomization: treatment resistant peptic ulcer disease, infectious or inflammatory bowel disease, pulmonary embolism
    14. Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
    15. Unable to comply with study procedures
    16. Patients with reproductive potential not implementing accepted and effective method of contraception.
    17. History of severe hypersensitivity reaction (≥grade 3) to docetaxel
    18. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
    19. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
    20. 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) (see Appendix A and B)
    21. Inadequate organ and bone marrow function as evidenced by:
    a) Hemoglobin <10.0 g/dL
    b) Absolute neutrophil count <1.5 x 109/L,
    c) Platelet count <100 x 109/L,
    d) AST/SGOT and/or ALT/SGPT >1.5 x ULN;
    e) Total bilirubin >1 x ULN,
    22. Serum creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with PSA response ≥ 50% after treatment with Abiraterone or Cabazitaxel in the first treatment period before cross over comparing groups defined by AKR1C3 levels as high or low at baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    At progression after the first treatment period before cross over.
    E.5.2Secondary end point(s)
    I. The proportion of patients with PSA response ≥ 50% after treatment with Abiraterone or Cabazitaxel in the first treatment period before crossover comparing groups defined by AR-V7 presence or abscence at baseline.
    II. The summary of the combined PSA progression free survival in the two treatment periods comparing groups defined by the combined AKR1C3 and AR-V7 patterns at baseline and sequence of treatments.
    III. The proportion of patients that have low expression of AR-V7 at baseline and who develops high expression during therapy with Abiraterone differs compared to corresponding group that receives Cabazitaxel as measured at first progression.
    IV. Blood based expression of biomarkers correlates to tissue based expression of the same markers.
    V. Progression free survival endpoints
    a. PSA and radiological PFS,
    b. Overall survival
    VI. Safety

    VII. Exploratory endpoints
    • Search for new biomarkers
    • Improvement in Pain Control
    • Quality of Life /FACT_P)
    • BSI (Bone Scan Index) in relation to PCGW2
    E.5.2.1Timepoint(s) of evaluation of this end point
    I. At progression after the first treatment period before cross over.
    II. End of study
    III. At progression after the first treatment period before cross over
    IV. End of study
    V. End of study
    VI. During the study
    VII. During the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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.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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 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
    LVLS
    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 months2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state82
    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)
    None
    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 Decision2015-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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