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    Summary
    EudraCT Number:2006-004564-32
    Sponsor's Protocol Code Number:NG 05 / 09
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-11-22
    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 number2006-004564-32
    A.3Full title of the trial
    The Prostate CARE Study: Capecitabine (Xeloda®) combined with Rhenium-188-HEDP in hormone refractory prostate cancer patients with bone metastases; a Capecitabine phase I dose escalation study and phase II efficacy study.
    A.3.2Name or abbreviated title of the trial where available
    The Prostate CARE Study
    A.4.1Sponsor's protocol code numberNG 05 / 09
    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 SponsorUniversity Medical center Utrecht
    B.1.3.4CountryNetherlands
    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 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 Yes
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharmaceuticals
    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.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 No
    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 nameRhenium-188-HEDP
    D.3.2Product code Rhenium-188-HEDP
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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 Yes
    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 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
    Hormone refractory prostate cancer with painful bone metastases
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    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 aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of capecitabine combined with Re-188-HEDP.
    The primary aim of the phase II part of this study is to obtain insight in the efficacy of Re-188-HEDP combined with capcitabine, as reflected by PSA.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are to determine the biodistribution of Re-188-HEDP when combined with capecitabine; to study heamtological toxicity; to monitor pain and analgesic consumption; to monitor quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Related to prostate cancer:
    1. Histologically documented adenocarcinoma of the prostate.
    2. Presence of more than one osteoblastic bone metastasis confirmed by 99mTc-labeled
    bisphosphonates bone scan performed within 8 weeks prior to study entry.
    3. Bone pain and/or painmedication.
    4. Clinically progressive hormone refractory disease, as documented by one or more of the following:
    a. Two documented consecutive increases in total PSA over a previous reference value (first increase at least one week after reference value). Increased total
    PSA level must be at least 5 µg/L.
    b. New lesion on bone scan (progressive measurable disease).
    c. Increase in bidimensionally measurable disease.
    5. Karnofsky performance status ³ 60% (Appendix III).
    6. Life expectancy of at least 3 months.
    7. Patients with lower urinary tract obstruction or incontinence must consent to
    catheterization of the bladder for up to 6 hours after administration of Re-188-HEDP .

    Related to previous or concomitant therapies:
    8. Patients receiving anti-androgen treatment can either stop or continue their treatment.
    Patients who stop anti-androgens must demonstrate no decrease in total PSA values on
    at least two occasions at least 1 week apart after anti-androgen withdrawal. Flutamide
    must be discontinued for 4 weeks, and bicalutamide, megestrol acetate, cyproterone
    acetate, or nilutamide must be discontinued for at least 6 weeks prior to study entry.
    Patients who continue anti-androgen treatment must go on with their treatment during
    the whole study period.
    9. Patients under LH-RH agonists must continue their treatment.

    Related to the patient:
    10. Age ³ 18 years.
    11. Ability to understand and willingness to sign a written informed consent document.

    E.4Principal exclusion criteria
    Related to prostate cancer:
    1. Patients with pathologic long-bone fractures (unless surgically stabilized), imminent
    pathologic long-bone fracture (cortical erosion on radiography > 50%), or clinical
    evident spinal cord compression.
    2. Patient known to have a malignancy other than prostate cancer (but not including basal
    cell carcinoma of the skin).

    Related to previous or concomitant therapies:
    3. Previous chemotherapy (including Estramustine) within 6 weeks prior to screening.
    4. Any other medicine taken with the intension to treat the disease (except LH-RH
    agonist).
    5. Use of Interferon-alpha, Allopurinol, Sorivudine and analogues and Folinic acid.
    6. Prior treatment with a systemic radiotherapeutic bone agent (only Sm-153-HEDP,
    Re-186 HEDP or Re-188-HEDP) within 3 months. Prior treatment with other
    radiotherapeutic bone agents (e.g., Sr-89-chloride, P-32 -phosphate) within 6 months.
    7. Patients receiving bisphosphonate therapy must be discontinued for at least 2 weeks
    prior to treatment with Re-188-HEDP.
    8. Receipt of any other investigational drug within 4 weeks of study entry.
    9. Previous hemi-body external radiation therapy.
    10. Receipt of external beam radiation for bone metastases with irradiation of bone
    marrow more than 25%, within 6 months of study entry.

    Related to the patient:
    11. Known hypersensitivity to 5-FU, Re-188-HEDP, Capecitabine or any of the
    excipients, or phosphate compounds.
    12. Patients whose medical history includes clinically significant bleeding disorders which
    might be exacerbated by study medication.
    13. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
    14. Patients with concurrent illnesses or treatments that might preclude study completion
    or interfere with study results.
    15. Patients with active CNS (grade 2 or higher) or epidural brain metastasis.
    16. Clinical diagnosis of disseminated intravascular coagulation
    17. Absolute neutrophil count, ANC < 2 109/L.
    18. Platelet count < 150 109/L.
    19. Hemoglobin < 6 mmol/L.
    20. Total PSA < 5 µg/L.
    21. Serum creatinine clearance < 50 ml/min (Cockroft and Gault).
    22. Bilirubin > 1.5 x ULN.
    23. SGOT/AST > 2.5 x ULN or SGPT/ALT 2.5 x ULN.
    E.5 End points
    E.5.1Primary end point(s)
    Cohorts of three successive patients will be treated with a combination of rhenium-188-HEDP and an increasing dose of Xeloda. If one or two DLT's occur in the cohort of three patients then the cohort will be increased to six patients. If maximum two out of six patients have a DLT then the next cohort will be tested. If at least three out of three patients or three out of six patients have a DLT then the MTD can be determined.
    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) No
    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
    Dose-escalation; dose-finding
    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 No
    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 Information not present in EudraCT
    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
    When the MTD of Xeloda has been defined in the phase I part of the study a phase II study will be performed. All patients in phase II will start treatment at the MTD level defined in phase I. Duration of participation will be 9 weeks. Follow-up will be continued after end of study for unresolved AE's that might be realted to one or both of the study drugs.
    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 months0
    E.8.9.1In the Member State concerned 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.1.3Elderly (>=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 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 state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    Follow-up will be continued after end of study for unresolved AE's that might be related to one or both study drugs. During the whole study and after end of study the patient will be under the care of his urologist or oncologist.
    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 Decision2006-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-01
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