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    Summary
    EudraCT Number:2006-006950-81
    Sponsor's Protocol Code Number:KTN32313R
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-07-25
    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 number2006-006950-81
    A.3Full title of the trial
    A PHASE 3 STUDY OF SAFETY AND EFFICACY OF KARENITECIN VERSUS TOPOTECAN ADMINISTERED FOR 5 CONSECUTIVE DAYS EVERY 3 WEEKS IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER
    A.4.1Sponsor's protocol code numberKTN32313R
    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 SponsorBioNumerik Pharmaceuticals, 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 nameKarenitecin
    D.3.2Product code BNP1350
    D.3.4Pharmaceutical form Concentrate for 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 codeBNP1350
    D.3.9.3Other descriptive nameKarenitecin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Hycamtin
    D.2.1.1.2Name of the Marketing Authorisation holderSmithKline Beecham plc
    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.3.4Pharmaceutical form Powder for concentrate for 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.3.9.3Other descriptive nameTopotecan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    advanced epithelial ovarian 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 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to determine the safety and efficacy of intravenous karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PHASE 3 STUDY OF SAFETY AND EFFICACY OF KARENITECIN VERSUS TOPOTECAN ADMINISTERED FOR 5 CONSECUTIVE DAYS EVERY 3 WEEKS IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER; AMENDMENT 1 DATE: 17 MAY 2007. This is the same protocol title as for the main study. There is not a second study title associated with this study.
    In addition to the previously stated primary and secondary endpoints for the main study, the sub-study will include evaluation of Karenitecin PK and assessment of the ECG for potential effect on cardiac repolarization.
    E.3Principal inclusion criteria
    1. Age ≥ 18 years.
    2. Documented histopathological or cytological diagnosis of stage III or IV epithelial ovarian cancer as defined by the International Federation of Gynecology and Obstetrics (FIGO) (Appendix D of the protocol).
    3. The following tumor histological epithelial cell types will be accepted:
    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Adenocarcinoma (grade ≥ 2) not otherwise specified.
    4. Documented resistance to platinum/taxane-based chemotherapy, as indicated by
    relapse/progression while on or within 6 months of completion of treatment in a first-line or second-line setting; or a best response of stable disease (SD) after 6 cycles of platinum/taxane treatment in the first-line setting. Platinum/taxane-based regimens must have included either cisplatin or carboplatin, and paclitaxel.
    5. Have measurable disease, defined by the presence of at least one radiographicallyconfirmed (computed tomography[CT]/magnetic resonance imaging [MRI]) measurable lesion that can be accurately measured in at least one dimension (longest diameter [LD] to be recorded) as ≥ 20 mm with conventional techniques (CT/MRI), or ≥ 10 mm with spiral CT scan.
    6. Documentation of progressive disease (PD) according to RECIST or WHO criteria following the immediate prior treatment regimen or a best response of SD after 6 cycles of platinum/taxane treatment in the first-line setting.
    7. More than 3 weeks (21 days) must have elapsed since completion of the last treatment with any investigational or approved hormonal therapy, radiation, chemotherapy, or surgery, prior to randomization.
    8. Have an ECOG PS ≤ 2 within 14 days before randomization.
    9. Have baseline laboratory parameters within the following ranges (without need for
    hematopoietic growth factor use or transfusion support) within 14 days before randomization:
    • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
    • Hemoglobin ≥ 9 g/dL
    • Platelet count ≥ 100 × 109/L
    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
    • Aspartate aminotransferase (AST/SGOT) ≤ 2 × ULN
    • Alanine aminotransferase (ALT/SGPT) ≤ 2 × ULN
    • Alkaline phosphatase ≤ 2.5 × ULN.
    10. Have a calculated creatinine clearance normalized to BSA that is > 40 mL/min determined within 14 days before randomization.
    11. Disease-free period of > 5 years from any previous malignancies, excluding curativelytreated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
    12. Provide informed consent within 21 days before randomization (informed consent to be obtained prior to any screening procedures).
    E.4Principal exclusion criteria
    1. Patients with the following tumor histological epithelial cell types will not be accepted:
    • Malignant Brenner or borderline tumor
    • Low-potential (grade 0) tumor
    • Squamous cell carcinoma
    • Granulosa theca cell tumor
    • Germ cell tumor
    • Sex cord-stromal tumor
    • Carcinosarcoma
    • Mixed Müllerian tumor
    • Metastatic carcinoma from other sites to ovary
    • Low-grade (grade 1) adenocarcinoma.
    2. Have current evidence of congestive heart failure (New York Heart Association Classification Class II or greater).
    3. Have a recent onset (< 6 months prior to randomization) of angina pectoris, unstable angina pectoris, uncontrolled ventricular tachycardia, myocardial infarction, stroke, or transient ischemic attacks.
    4. Have recent history (within 6 months) of uncontrolled seizures.
    5. Have an active infection (including viral, fungal, bacterial, rickettsial, mycobacterial, or parasitic).
    6. Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
    7. Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
    8. Received prior treatment with any platinum agent other than cisplatin or carboplatin.
    9. Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
    10. Concurrently receiving investigational drug therapy for cancer treatment or investigational treatment for any other indication.
    11. Have a positive pregnancy test or are unwilling to practice an effective contraceptive method during study (premenopausal patients).
    12. Are breast feeding.
    13. Have a life expectancy < 3 months.
    14. Are judged by the Investigator to be unlikely to be able to fully comply with the study protocol and/or to complete the study or required study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be Progression Free Survival (PFS); defined as the time period from the date of randomization to the date of first radiographical documented progressive disease (PD) or date of death due to any cause, taking the event date that occurs first.
    The date of PD will be determined by radiographical objective disease (RECIST) measurement.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 years5
    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 years5
    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 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) 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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 500
    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)
    Subject will revert back to standard clinical care following participation.
    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 Decision2007-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-07
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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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