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    Summary
    EudraCT Number:2008-006425-14
    Sponsor's Protocol Code Number:PDX-014
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-05-21
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-006425-14
    A.3Full title of the trial
    Phase 1/2 Study of Pralatrexate in Female Patients with Previously-treated Advanced or Metastatic Breast Cancer
    A.4.1Sponsor's protocol code numberPDX-014
    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 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.3.8INN - Proposed INNPralatrexate
    D.3.9.1CAS number 146464-95-1
    D.3.9.2Current sponsor codePDX
    D.3.9.3Other descriptive name(RS)-10-Propargyl-10-deazaaminopterin
    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 agent
    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
    Previously-treated Advanced or Metastatic Breast Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1 Objective(s):
    • To determine the maximum tolerated dose (MTD) for pralatrexate up to 190 mg/m2 without vitamins in advanced or metastatic breast cancer patients who have failed prior chemotherapy.

    Phase 2 Objective(s):
    • To assess preliminary efficacy of pralatrexate in this patient population.
    E.2.2Secondary objectives of the trial
    Phase 2 Objective(s):
    • To evaluate the safety and tolerability of pralatrexate with and without vitamin supplementation in this patient population.
    • To determine the pharmacokinetic (PK) profile of pralatrexate.
    • To assess the potential relationships between pralatrexate response and relevant biomarkers and correlate this with dose and plasma PK.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. Histologically and/or cytologically confirmed human epidermal growth factor receptor 2 (HER-2) negative advanced or metastatic breast cancer, as shown by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC).
    2. Patients must have failed at least 1 prior chemotherapy regimen for advanced or metastatic disease.
    3. Patients with advanced or metastatic disease resistant to both a taxane and an anthracycline-containing chemotherapy regimen or resistant to taxanes and for whom further anthracycline therapy is not indicated. Taxane resistance is defined as progressive disease while on or within 3 months from end of treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
    4. Patients with controlled brain metastases must have completed appropriate radiation therapy and if on corticosteroids, be on a stable or tapering dose for at least 28 days prior to study entry.
    5. Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST): at least 1 uni-dimensionally measurable non-bony target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) or chest x-ray (≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan) outside a previously radiated field.
    6. Female ≥ 18 years of age.
    7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    8. Life expectancy > 3 months.
    9. Adequate hematological, hepatic, and renal function as defined by: white blood cell (WBC) count ≥ 2500 cells/μL (≥ 2.5 x 109 cells/L), absolute neutrophil count (ANC) ≥ 1500 cells/μL (≥ 1.5 x 109 cells/L); platelet count ≥ 100,000/μL (≥ 100 x 109/L); hemoglobin ≥ 10 g/dL (≥ 100 g/L); calculated creatinine clearance (CrCl) of ≥ 50 mL/min; total bilirubin ≤ 1.5 x the upper limit of normal (ULN); aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and gamma-glutamyltransferase (γ-GT) ≤ 3 x ULN (if clearly attributable to liver metastases, ALT/AST/γ-GT ≤ 5 x ULN is permitted).
    10. Females of childbearing potential have a negative serum pregnancy test within 14 days prior to enrollment and must agree to practice a medically acceptable and effective 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.
    11. Accessible for repeat dosing and follow- up.
    12. Given written informed consent (IC).
    E.4Principal exclusion criteria
    1. Patients with bone metastasis only.
    2. A single metastatic site without histological proof of the lesion being metastatic breast cancer.
    3. Patients with inflammatory breast cancer.
    4. Receipt of systemic chemotherapy, hormone therapy, radiation therapy, or other investigational therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C) prior to enrollment, with the following exceptions noted:
    • Bisphosphonates are permitted if ongoing.
    • Phase 1 only: prior treatment with capecitabine, 5-fluorouracil (5-FU), or antifolates other than methotratrexate is excluded within 6 months prior to enrollment.
    • Prior treatment with methotrexate is excluded.
    • Prior treatment with anti-angiogenics is excluded within 6 months prior to enrollment.
    5. Prior treatment with > 2 prior chemotherapy regimens (3 prior chemotherapy regimens are allowed if 1 of the treatments was neoadjuvant or adjuvant chemotherapy).
    6. Previous exposure to pralatrexate.
    7. Anthracycline maximum cumulative dose exceeded (ie, doxorubicin with no risk factors = 550 mg/m2, otherwise 450 mg/m2; epirubicin = 720 mg/m2).
    8. Extensive prior radiation therapy on more than 30% of bone marrow reserve or prior bone marrow/stem cell transplantation.
    9. Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification.
    10. Uncontrolled hypertension.
    11. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
    12. Females who are pregnant or breastfeeding.
    13. Major surgery within 14 days of enrollment.
    14. Active concurrent primary malignancy (except adequately treated in situ cervical cancer and basal cell skin cancer).
    15. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent or limit study compliance.
    16. Human immunodeficiency virus (HIV)-positive diagnosis.
    17. Known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    • The primary endpoint is whether or not the patient experiences a DLT.
    (DLT must be treatment-related, and occur in cycle 1)

    Phase 2:
    • The primary endpoint is the occurrence of any of the following regardless of when they occur:
    - ≥ Grade 3 treatment-related hematological AE, excluding anemia, lasting for ≥ 7 days.
    - ≥ Grade 3 treatment-related neutropenic fever.
    - ≥ Grade 3 treatment-related non-hematological AE, excluding nausea and vomiting.
    - Greater than 28 days has elapsed since the last dose of pralatrexate due to treatment-related AEs.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    MTD for up to 190mg/m2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 78
    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)
    Provided in protocol
    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 Decision2009-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-05
    P. End of Trial
    P.End of Trial StatusOngoing
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