Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2006-001933-16
    Sponsor's Protocol Code Number:26866138PCR2002
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-10-18
    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 ConcernedGreece - EOF
    A.2EudraCT number2006-001933-16
    A.3Full title of the trial
    "A Phase II, Open-Label study of Velcade(Bortezomib)for patients with Androgen-Independent Prostate Carcinoma who progressed on or after prior chemotherapy"
    A.3.2Name or abbreviated title of the trial where available
    Velcade Phase II in AIPCa
    A.4.1Sponsor's protocol code number26866138PCR2002
    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 SponsorChristos N. Papandreou
    B.1.3.4CountryGreece
    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 VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-CIlag International N.V.( Local representative: Janssen-Cilag Pharmaceutical S.A.C.I)
    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 nameVELCADE 3.5mg powder for solution for injection
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNBortezomib
    D.3.9.1CAS number 179324-69-7
    D.3.9.3Other descriptive nameBoronic Acid: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl- 2[pyrazinylcarbonyl)amino]propyl]amino]butyl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3,5
    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.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
    Treatment of patients with Androgen-Independent Prostate Carcinoma who progressed on or after prior chemotherapy.
    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
    Evaluate the efficacy of VELCADE (bortezomib) in patients with metastatic Androgen-Independent Prostate Cancer (AIPCa) progressing on or after prior chemotherapy, as measured by the objective response rate and PSA response rate of the treatment in patients with AI-PCa who failed up to two prior chemotherapy regimens.
    To evaluate the toxicity of the treatment in patients with metastatic AI-PCa progressing after chemotherapy.
    E.2.2Secondary objectives of the trial
    Investigate the degree of proteasome inhibition in peripheral blood in patients with advanced androgen-independent prostate cancer who are receiving VELCADE.
    Evaluate the effect of VELCADE (bortezomib) on prostate-specific antigen (PSA) levels in patients with baseline PSA levels 5 ng/mL and correlate with the degree of proteasomal inhibition in blood.
    Assess serum IL-6 levels (as a surrogate of NFB activation) and investigate the relationship between serum interleukin-6, serum PSA levels and peripheral blood proteasomal inhibition in patients with advanced androgen-independent prostate cancer.
    Monitor the effect of VELCADE (bortezomib) on selected parameters of clinical benefitCollect and store plasma, urine and tissue samples (i.e. prostate, bone marrow and / or lymph node) from consenting patients (optional procedures) for future studies (i.e., study the effect of the therapy on known targets of NFB, growth factors for prostate cancer, and bone remodeling markers).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Signed informed consent.
    2 Histologic demonstration of adenocarcinoma of the prostate. If no sample of the primary tumor was obtained, biopsy of a metastatic site is sufficient if the tissue stains positive for PSA.
    3 Androgen-Independent progression of prostate carcinoma, as shown by: Serum testosterone level of < 50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of serum testosterone (LHRH agonists) should continue, and patients must be off anti-androgens, such as flutamide (Eulexin), bicalutamide (Casodex) or nilutamide (Nilandron). They must have no evidence of response at least 4 weeks (6 weeks for bicalutamide) since anti-androgen withdrawal (or progression at any time since anti-androgen withdrawal), and either symptomatic progression, or, if patient is asymptomatic, then progressive measurable or evaluable disease defined as:
    - Progressive measurable disease (changes in the size of lymph nodes or parenchymal masses on physical examination or x-ray, as per the RECIST CRITERIA- Attachment 4), or
    - Progressive bone metastasis [presence of new lesion(s) on a bone scan]. Patients with progressive bone disease have to have also progressive PSA to be eligible for enrollment in the study, given the difficulty in assessing response in bone, or
    - Progressive PSA, is defined as an increase in PSA, as determined by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement.
    If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the patient to be eligible for enrollment in the study.
    The confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be 5 ng/mL, if the PSA criterion for disease progression is to be used as the only criterion for disease progression, prior to entry into the study [23].
    4 Patients should have had at least one and up to 2 prior chemotherapy regimens for hormone-refractory prostate cancer, provided that more than 4 weeks (6 weeks for nitrosoureas) have elapsed since the last treatment and patients have recovered from toxicity.
    5 Up to one prior dose of Strontium-89 (Metastron) or Samarium is allowed, if given more than 12 weeks (4 weeks for Samarium) prior to study entry. Patients may have had radiation therapy (completed more than 4 weeks prior to initiation of the study).
    6 Previous treatment with PC-SPES, herbal / alternative medicines, anti-angiogenesis inhibitors, immunotherapy, or other non-androgen mediated pathways (such as epidermal growth factor receptor antagonists or farnesyl transferase inhibitors) is allowed, provided that there is unequivocal evidence of disease progression since completion of the therapy and more than 4 weeks (8 weeks for immunotherapy) have elapsed since last treatment.
    7 Patients must be at least 4 weeks from prior surgery.
    8 Life expectancy of at least 12 weeks
    9 Zubrod performance status of < 1 [Attachment 5].
    10 A resting Left Ventricular Ejection Fraction (LEVF) > 50%.
    11 ALT and AST 2.5  the ULN, or, if the patient has liver metastases, 5  the ULN.
    12 Total bilirubin 1.5 the upper limit of normal (ULN).
    13 Serum creatinine < 2.0 mg/dl (or, if creatinine > 2 mg/dl, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft formula: CLcr= [(140-age) x wt (kg)] / [72 x serum creatinine (mg/dl)].
    14 Absolute neutrophil count (ANC) 1,500/mm3.
    15 Platelets 100,000/mm3.
    16 Hemoglobin >9.0 g/dL.
    E.4Principal exclusion criteria
    Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
    1 Patient has never received chemotherapy for prostate carcinoma or has received chemotherapy within four weeks (six weeks for nitrosoureas) or antibody therapy within eight weeks of enrollment.
    2 Patient has received radiation therapy or Samarium-153 within four weeks of enrollment, or Strontium-89 within 12 weeks of enrollment.
    3 Patient has not recovered from all serious toxic effects of previous chemotherapy or radiation or antibody therapy.
    4 Patient received treatment with flutamide within four weeks of enrollment or nilutamide or bicalutamide within six weeks of enrollment and there is no evidence of disease progression since discontinuation of the anti-androgen.
    5 Patient has had any major surgery within four weeks of enrollment.
    6 Patient has significant atherosclerotic disease, as defined by:
    a) myocardial infarction within six months of enrollment, uncontrolled / unstable angina pectoris or electrocardiographic evidence of acute ischemia
    b) clinically significant ventricular arrhythmias,
    c) symptomatic congestive heart failure
    d) significant conduction abnormalities: 2nd or 3rd degree AV blocks, bifascicular block (defined as Left Anterior Hemiblock in the presence of Right Bundle Branch Block),
    e) claudication limiting activity and
    f) history of cerebrovascular events within the last year -including transient ischemic attack (TIA)
    7 Patient has uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension.
    8 Patient has uncontrolled brain metastases or central nervous system disease.
    9 Patient has  Grade 2 peripheral neuropathy or neuropathic pain (per NCI CTCAE v.3.0, Attachment 7).
    10 Patient has an uncontrolled inter-current illness (e.g., active infection).
    11 Patients with a history of another malignancy (except from superficial bladder cancer or basal cell carcinoma of the skin) within 5 years prior to study entry.
    12 Patient has another serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the patient’s ability to provide informed consent or with the completion of treatment according to this protocol.
    13 History of allergic reaction attributable to compounds containing boron or mannitol
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the efficacy of VELCADE (bortezomib) in patients with metastatic Androgen-Independent Prostate Cancer (AIPCa) progressing on or after prior chemotherapy, as measured by the objective response rate and PSA response rate of the treatment in patients with AI-PCa who failed up to two prior chemotherapy regimens.
    To evaluate the toxicity of the treatment in patients with metastatic AI-PCa progressing after chemotherapy.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Translational research
    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 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    single arm
    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.8.4.1Number 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 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
    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
    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) No
    F.1.3Elderly (>=65 years) No
    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 state56
    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)
    Not Different
    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 Decision2006-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 22:25:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA