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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2007-004671-19
    Sponsor's Protocol Code Number:PDX 011
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-03-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-004671-19
    A.3Full title of the trial
    A Phase 2, Single-Arm Study of Pralatrexate in Patients with Advanced
    or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
    A.4.1Sponsor's protocol code numberPDX 011
    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 SponsorAllos Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 namepralatrexate
    D.3.2Product code PDX
    D.3.4Pharmaceutical form Intravenous 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.3.9.1CAS number 146464-95-1
    D.3.9.2Current sponsor codePDX
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeChemotherapy product
    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 or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10007294
    E.1.2Term Carcinoma bladder recurrent
    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 objective response rate (CR + PR) for pralatrexate with concurrent vitamin B12 and folic acid supplementation in the treatment of patients with advanced or metastatic relapsed TCC (Transitional Cell Carcinoma) of the urinary bladder.
    E.2.2Secondary objectives of the trial
    1. To determine the duration of response, clinical benefit rate, progression-free survival (PFS), and overall survival (OS) in patients with advanced or metastatic relapsed TCC of the urinarybladder treated with pralatrexate.

    2. To evaluate the safety and tolerability of administration of pralatrexate with concurrent vitamin B12 and folic acid supplementation in patients with advanced or metastatic relapsed TCC of the urinary bladder.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder. Fine needle aspirate will not be accepted.
    2. Relapsed after treatment with no more than 1 platinum-based systemic chemotherapy regimen for metastatic disease or relapsed within 6 months of previous platinum-based neoadjuvant/adjuvant therapy. Patient has recovered from the toxic effects of prior therapy. Previous intravesical therapy is allowed. Prior surgical resection is allowed, as long as the patient has recovered.
    3. Measurable disease, outside a previously irradiated region, per Response Evaluation Criteria in Solid Tumors (RECIST).
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    5. ≥ 18 years of age.
    6. Adequate hematologic, hepatic, and renal function as defined by: Hgb ≥ 10 g/dL (≥ 100 g/L); WBC count ≥ 2500 cells/mm3 (≥ 2.5 x 109 cells/L); absolute neutrophil count (ANC)≥ 1500 cells/mm3 (≥ 1.5 x 109 cells/L); platelet count ≥ 100,000/mm3; calculated CrCl of ≥ 50 mL/min; total bilirubin ≤ 1.5 x upper limit of normal (ULN); and aspartate aminotransferase (AST, serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT, serum glutamic-pyruvic transaminase [SGPT]) ≤ 3 x ULN.
    7. The patient has been on a regimen of 1-1.25 mg PO QD of folic acid for at least 7 days prior to enrollment and has received 1 mg IM of vitamin B12 within 10 weeks of enrollment.
    8. Women of childbearing potential have a negative serum pregnancy test within 14 days prior to enrollment and must agree to practice a medically acceptable contraceptive regimen from enrollment until at least 30 days after the last administration of pralatrexate. Patients who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test.
    9. Men who are not surgically sterile and whose partner is of childbearing potential must be practicing a medically safe and effective contraceptive regimen from the time of pralatrexate initiation, and agree to continue practicing until at least 90 days after the last administration of pralatrexate.
    10. Accessible for repeat dosing and follow-up.
    11. Given written informed consent (IC).
    E.4Principal exclusion criteria
    1. Active concurrent primary malignancy (except non-melanoma skin cancer, in situ carcinoma of the cervix, or occult, indolent carcinoma of the prostate [undetectable prostate-specific antigen, Gleason score ≤ 7, no seminal vesicle invasion, and no extraprostatic extension]). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years. In the case of a single extrapelvic metastatic site, irrespective of the patient having a history of previous malignancy, a biopsy proof of the metastatic diseased organ will be necessary.
    2. More than one previous regimen for either neoadjuvant/adjuvant or advanced disease (except simultaneous chemoradiotherapy).
    3. Evidence of clinically significant active thirdspace phenomenon; ie, peripheral edema (≥ +2), active pleural effusions, or ascites.
    4. Use of any investigational drugs, biologics, or devices within 28 days prior to study
    enrollment.
    5. Previous exposure to other antifolates (eg, methotrexate, pemetrexed [Alimta]). Previous methotrexate is allowed, only if it was part of a M-VAC or MCV regimen and provided that 6 months has elapsed since treatment with M-VAC or MCV.
    6. Previous exposure to pralatrexate.
    7. Women who are pregnant or breastfeeding.
    8. Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification.
    9. Uncontrolled hypertension.
    10. Known human immunodeficiency virus (HIV)-positive status.
    11. CNS metastatic disease.
    12. Major surgery within 2 weeks of study enrollment.
    13. Receipt of any conventional systemic chemotherapy or RT within 4 weeks (6 weeks for nitrosoureas, mitomycin C) prior to study enrollment.
    14. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
    15. Dementia or significantly altered mental status that would prohibit the understanding and giving of IC or limit study compliance.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response
    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 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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 50
    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 Decision2008-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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