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    Summary
    EudraCT Number:2004-002094-23
    Sponsor's Protocol Code Number:EORTC 30021
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-08-25
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2004-002094-23
    A.3Full title of the trial
    Randomized phase II trial of Docetaxel (Taxotere) and Oblimersen vs Taxotere alone in patients with HRPC
    A.4.1Sponsor's protocol code numberEORTC 30021
    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 SponsorEORTC
    B.1.3.4CountryBelgium
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 namedocetaxel
    D.3.2Product code docetaxel
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous 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 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 nameGenasense
    D.3.2Product code G3139
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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.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
    Patients with Hormone- Refractory Prostate Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10001186
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a randomized phase II trial to evaluate the toxicity and activity (in terms of PSA response) of the combination of docetaxel and oblimersen in hormone refractory prostate cancer.
    The trial is randomized against docetaxel alone which will serve as a reference group to further validate the sample used in the trial.
    E.2.2Secondary objectives of the trial
    time to progression, toxicity, survival
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    ♦ Histologically proven prostate adenocarcinoma
    ♦ Hormone refractory prostate cancer defined as progression under prior hormonal treatment with
    LH-RH analogues or orchiectomy and anti-androgens, given either together or consecutively.
    ♦ Progressive disease is defined as PSA progression documented by 2 increased PSA values over
    a previous reference value. PSA fluctuations should be handled as defined in chapter 7.1.
    ♦ Patients must have a demonstrated continued elevation of PSA for at least 6 weeks after
    discontinuation of antiandrogens prior to registration on study
    ♦ PSA greater or equal to 5 ng/ml (hybritech or equivalent) within 1 week prior to randomisation
    ♦ No clinical evidence of brain metastases
    ♦ No evidence of painful and/or destructive bone metastases for which radiation therapy,
    bisphosphonates or bone-seeking radionucleides are considered necessary by the treating
    physician. Other bone metastases are allowed.
    ♦ Age ≥18 years
    ♦ WHO Performance status 0-2
    ♦ No regular (daily) intake of opioid analgesics
    ♦ No prior treatment with chemotherapy, bone-seeking radionucleides or radiotherapy involving
    more than 25% of marrow producing area. (Prior use of Estramustine phosphate and/or
    bisphosponates are allowed).
    ♦ No prior hormonal manipulation with PC-SPES within the last 6 weeks prior to entry on study
    ♦ Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at
    least 6 weeks prior to randomization.
    ♦ No concurrent treatment with other experimental drugs or anti-cancer drugs (except LH-RH
    agonist) nor bisphosphonates.
    ♦ Castrate level of testosterone (<= 50 ng/mL). Patients with medical castration with LHRH
    analogue must continue LHRH analogue
    ♦ Adequate venous access
    ♦ Adequate hematological functions as assessed by Hb ≥ 10 g/dl WBC ≥ 3.500 109/l, ANC ≥ 1.5
    109/l , and platelets ≥ 100 109/l.
    ♦ Adequate liver function as assessed by bilirubin ≤ upper limit of the normal range (UNL) and
    ASAT ≤ 1.5 x UNL and ALAT ≤ 1.5 x UNL
    ♦ Adequate renal function as assessed by serum creatinine ≤ 1.5 xULN or calculated creatinine
    clearance ≥ 50 ml/min according to Cockcroft formula. (see Appendix C for the formula)
    ♦ Partial thromboplastin time (PTT) <= 1.5xUNL and Prothrombin time (PT) <=1.5xUNL (or
    INR<=1.3)
    ♦ No known hypersensitivity to oligonucleotides or any component of the oblimersen formulation
    or to drugs formulated with polysorbate. No hypersensitivity to phosphorothioates.
    ♦ No CVA or transient ischemic attack or myocardial infarction attacks within the past 6 months
    ♦ No active infection, no known HIV
    ♦ No history of interstitial pneumonitis or pulmonary fibrosis
    ♦ No unstable angina or pulmonary embolism, no uncontrolled hypertension
    ♦ No history of deep venous thrombosis within 6 months prior to entry on study
    ♦ No pre-existing neuropathy
    ♦ No second primary cancer (except adequately treated superficial urothelial or skin cancer
    without signs of recurrence in the past 5 years)
    ♦ Absence of any psychological, familial, sociological or geographical condition potentially
    hampering compliance with the study protocol and follow-up schedule; those conditions should
    be discussed with the patient before registration in the trial
    ♦ Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

    Patients can only be randomized in this trial once
    E.4Principal exclusion criteria
    Please refer to Inclusion Criteria above.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints

    1. PSA response defined as a 50% decline from baseline value confirmed by a second value

    obtained at least 4 weeks apart according to Bubley criteria


    2. Occurrence of Major toxic events



    Any grade 4 haematological and non hematological toxicity except asymptomatic grade
    4 neutropenia (ANC<500/mm3) lasting less than 7 days

    Febrile neutropenia grade 3 for > 5 days or any Grade 4 febrile neutropenia
    sepsis (=grade 3 or 4)
    Severe (grade 3 or 4) hemorrhage-bleeding associated with grade>2 thrombocytopenia
    (<50.000/mm3)

    · Renal toxicity grade 3 or 4 (serum creatinine > 3xULN or need of dialysis)

    · Stop of treatment due to unacceptable toxicity

    · Death at least possibly due to toxicity
    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 No
    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 Yes
    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) Yes
    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
    End of study occurs when all of the following criteria have been satisfied:

    1. Thirty days after all patients have stopped protocol treatment

    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol

    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 102
    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 from the expected normal treatment which a patient would receive
    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 Decision2004-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-09-29
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    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
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