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    Summary
    EudraCT Number:2006-002276-17
    Sponsor's Protocol Code Number:ET-B-025-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-06-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2006-002276-17
    A.3Full title of the trial
    Phase II Study of Yondelis® in Men with Advanced Prostate Carcinoma

    Estudio fase II con Yondelis en hombres con cáncer de próstata avanzado
    A.4.1Sponsor's protocol code numberET-B-025-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPharma Mar SA, Sociedad Unipersonal
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameYONDELIS (trabectedin)
    D.3.2Product code ET-743, R279741, RWJ-680581
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNtrabectedin
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeET-743
    D.3.9.3Other descriptive nameEcteinascidin 743
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameYONDELIS (trabectedin)
    D.3.2Product code ET-743, R279741; RWJ680581
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNtrabectedin
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeET-743
    D.3.9.3Other descriptive nameEcteinascidin 743
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Advanced Prostate Carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and efficacy of Yondelis®(trabectedin) treatment in metastatic prostate carcinoma

    In Cohort A: To measure PSA response in men with AIPC treated with Yondelis®

    In Cohort B: To measure PSA response, duration of response, and time to progression in an additional cohort of 16 prostate cancer subjects previously treated with docetaxel that will be treated with YONDELIS® administered by a 24-h infusion every 3 weeks
    E.2.2Secondary objectives of the trial
    In Cohort A:
    To assess the safety of administration of Yondelis® as a weekly, three-hour
    infusion in this population of patients.
    To measure , duration of response and time to progression in men with AIPC treated
    with Yondelis®.
    In Cohort B:
    To assess the safety of administration of Yondelis® as a 24-hours infusion every three weeks in these subjects
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    In Cohort A:
    . Signed informed consent
    · Histologically confirmed adenocarcinoma of the prostate
    · Radiographically documented metastatic disease
    · Surgical or chemical castration
    · PSA > 5 ng/ml
    · Androgen-independent disease, as defined by detectable, rising PSA in two consecutive measurements at least one week apart, with a minimum increment of at least 5 ng/ml above the nadir
    · No more than one previous chemotherapy regimen
    · ECOG/WHO performance status of 0, 1 or 2
    · Adequate bone marrow reserve(s):
    - Neutrophil count > 1,500/ ml
    - Platelet count > 100,000/ ml
    · Adequate hepatic function:
    - Serum bilirubin < 1.0 x upper limit of normal
    - Serum alkaline phosphatase < 1.5 x upper limit of normal
    NOTE: If serum alkaline phosphatase is elevated, measurement of 5’ nucleotidase (5’NT) and gamma glutamyl transferasa (GGT) or alkaline phosphatase liver fraction should be performed, and if either of these is within normal limits (suggesting bone origin of abnormal alkaline phosphatase), patient may be included.
    - AST, ALT < 2.5 x upper limit of normal
    - Albumin > 2.5 g/dl
    · Adequate renal function, with serum creatinine < 1.5 x ULN

    In Cohort B
    · Signed informed consent
    · Histologically confirmed adenocarcinoma of the prostate
    · Radiographically documented metastatic disease
    · Surgical or chemical castration
    · PSA > 5 ng/ml
    · Androgen-independent disease, as defined by detectable, rising PSA in two consecutive measurements at least one week apart, with a minimum increment of at least 5 ng/ml above the nadir
    · Previous treatment with one docetaxel based chemotherapy regimen
    · ECOG/WHO performance status of 0, 1 or 2
    · Adequate bone marrow reserve(s):
    - Neutrophil count > 1,500/ μl
    - Platelet count > 100,000/ μl
    - Adequate hepatic function:
    - Serum bilirubin < 1.0 x upper limit of normal
    - Serum alkaline phosphatase < 1.5 x upper limit of normal
    - NOTE: If serum alkaline phosphatase is elevated, measurement of 5’ nucleotidase (5’NT) or gamma glutamyl transferasa (GGT) or alkaline phosphatase liver fraction should be performed, and if either of these is within normal limits (suggesting bone origin of abnormal alkaline phosphatase), patient may be included
    - AST, ALT < 2.5 x upper limit of normal
    - Albumin > 2.5 g/dl
    · Adequate renal function, with serum creatinine < 1.5 x ULN.


    E.4Principal exclusion criteria
    In Cohort A:
    . Small cell carcinoma of the prostate
    · Current treatment with chemotherapy or radiation therapy
    · Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed within four weeks of entry
    · Treatment with chemotherapy within 4 weeks of study entry
    · Patient not employing adequate contraception
    · Other serious illness or medical conditions, specifically:
    - Uncontrolled congestive heart failure or HISTORY of myocardial infection or active
    angina pectoris within 6 months preceding registrations
    - Active infectious process
    - Chronic active liver disease, including chronic hepatitis B, chronic hepatitis C, or
    cirrhosis
    · Current anticancer treatment with any other non-FDA-approved investigational drug
    · ECOG performance status of 3 or worse

    In Cohort B:
    · Small cell carcinoma of the prostate
    · Treatment with chemotherapy or radiation therapy was terminated at least 4 weeks before study entry
    · Treatment with extensive external beam radiation therapy or radionuclide therapy within six weeks of study entry. Palliative radiation involving less than 20% of bone marrow reserves must have been completed at least four weeks before study entry
    · Treatment with chemotherapy terminated at least 4 weeks before study entry
    · Patient not employing adequate contraception
    · Other serious illness or medical conditions, specifically:
    -Uncontrolled congestive heart failure or HISTORY of myocardial infection or active angina pectoris within 6 months preceding registrations
    - Active infectious process
    - Chronic active liver disease, including chronic hepatitis B, chronic hepatitis C, or cirrhosis
    · Current anticancer treatment with any other non-FDA-approved investigational drug
    · ECOG performance status of 3 or worse

    E.5 End points
    E.5.1Primary end point(s)
    PSA response, duration of response, and time to progression
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Patients will be assessed for the endpoints of survival, serum PSA and toxicity. Based on these assessments, Yondelis® may be administered until progressive disease or until major toxicity occurs.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 49
    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 Decision2006-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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