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    Summary
    EudraCT Number:2008-000907-27
    Sponsor's Protocol Code Number:D2782C00010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-000907-27
    A.3Full title of the trial
    A Phase II, Single Arm, Single Agent, Multicentre, Adaptive 2-Stage Study to Evaluate the Efficacy, Safety and Pharmacokinetics of AZD4877 Administered Weekly in Patients with Recurrent Advanced Urothelial Cancer
    A.4.1Sponsor's protocol code numberD2782C00010
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 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 nameAZD4877
    D.3.2Product code AZD4877
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAZD4877
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Stage IV urothelial Cancer
    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
    To assess the effect of AZD4877 on the objective response rate (ORR) in patients with recurrent advanced urothelial cancer receiving AZD4877 at the selected dose level of 25 mg once weekly, with response including complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumours (RECIST)
    E.2.2Secondary objectives of the trial
    · To describe the efficacy of AZD4877 in terms of disease control rate (DCR: CR, PR, and durable stable disease (SD)), duration of objective tumour response (DoR), progression-free survival (PFS) and overall survival (OS)
    To evaluate the safety and tolerability of AZD4877 by assessment of adverse events (AE), changes in laboratory values, vital signs and incidence of protocol-defined dose modifications or omissions
    To evaluate the pharmacokinetics (PK) of AZD4877 in urothelial cancer patients by Cmax
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of written informed consent
    2.Male or female age ≥18 years
    3.Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra). Mixed histology is allowed as long as the predominant histology is TCC
    4.TNM Stage IV disease (see Appendix G) that is not amenable to curative surgery and/or radiotherapy
    5.First recurrence after treatment with a maximum of two chemotherapeutic regimens, one of which must have been for unresectable and/or locally advanced disease, and the other of which must have been in either the adjuvant or neo-adjuvant setting.
    6.Measurable disease per RECIST criteria (Appendix D). Previously irradiated lesions are not considered measurable
    7.Eastern cooperation Oncology Group (ECOG) performance status of 0, 1, or 2 (Appendix C)C)
    E.4Principal exclusion criteria
    1.Prior treatment with investigational or standard anti-cancer agents, including radiotherapy, within 4 weeks prior to first dose of study treatment; 6 weeks if prior systemic mitomycin, nitrosourea, or suramin. One exception to this is palliative radiotherapy given (up to one week prior to study entry) for pain to non-target lesion bony metastases. Another exception to this is hormonal therapy for prostate cancer.
    2. Inadequate bone marrow reserve as demonstrated by absolute neutrophil count (ANC) <1.5 x 109/L, platelet count (PLT) <100 x 109/L, or haemoglobin (Hgb) ≤9 g/dL
    3.Inadequate liver function as demonstrated by alanine amino transferase (ALT) or aspartate transaminase (AST) >2.5 x upper limit of normal (ULN); >5 x ULN in the presence of liver metastases
    4.Impaired renal function, defined by creatinine >1.5 x ULN or creatinine clearance <40 mL/min, estimated by Cockcroft-Gault equation or measured via 24 h urine creatinine
    5.Any evidence of severe or uncontrolled systemic diseases including known cases of Hepatitis B or C or human immunodeficiency virus (HIV). Screening for chronic conditions is not required, although patients known to have such conditions at screening should not be included
    6.Unresolved toxicity greater than CTCAE grade 1 from previous anti-cancer therapy (excluding neurotoxicity or alopecia) or incomplete recovery or healing from previous surgery, unless agreed by AZ and the PI with documentation
    7.Presence of currently active CNS involvement or clinical evidence of active CNS disease.
    8.Patients with massive pleural effusions or ascites unless drained
    9.Pregnancy or breast-feeding. Women of childbearing potential must have a negative pregnancy test prior to starting first dose of study treatment
    10.Any severe concomitant condition which, in the opinion of the PI, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
    11.Involvement in the planning and conduct of the study (applies to both AZ staff and study centre personnel)
    12.Major surgery, in the opinion of the PI, within 4 weeks prior to first dose of study treatment
    13.Incomplete healing from prior bladder surgery, biopsy, or exenteration, or if surgical revisions anticipated in next 2 months after study entry
    14.Previous (within the last 5 years) or concurrent malignancies of other histologies, with the exception of cervical carcinoma in situ, adequately treated basal cell, squamous cell carcinoma of the skin, or prostate cancer
    15. Use of any known significant modulators of CYP3A4 within 2 weeks prior to the first dose of AZD4877 and up to Cycle 1, Day 8: Barbiturates including primidone, carbamazepine drugs including oxcarbazepine, clarithromycin, erythromycin, fluconazole, griseofulvin, hydantoins, itraconazole, ketoconazole, miconazole, nefazodone, rifampicin, troleandomycin, protease inhibitors, St. John’s wort, grapefruit juice and Seville orange juice (Preceding agents may be used after Cycle 1 Day 8 if deemed medically necessary by the PI and AZ
    16.Previous participation in any AZD4877 study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is:
    · ORR: defined as the proportion of patients with CR or PR as per RECIST. CR and PR must be confirmed 4 weeks later, as described in Appendix D. Patients without sufficient information (including missing values) for response assessment will be considered non-responders
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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
    The end of the study in Germany will be when all patients finished study therapy, all data are collected and all sites are closed.
    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 months6
    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 months6
    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 Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 50
    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)
    See protocol section 3.5.7
    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 Decision2008-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-09
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