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    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   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:2008-005576-26
    Sponsor's Protocol Code Number:08-PIR-04
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-005576-26
    A.3Full title of the trial
    A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic or Unresectable Locally Advanced Platinum-Resistant Ovarian Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic or Unresectable Locally Advanced Platinum-Resistant Ovarian Cancer
    A.4.1Sponsor's protocol code number08-PIR-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00802945
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNektar Therapeutics
    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 supportNektar Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAptiv Solutions (UK) Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address43d Discovery Terrace, Heriot-Watt Research Park
    B.5.3.2Town/ cityRiccarton, Edinburgh
    B.5.3.3Post codeEH14 4AP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440131449 8888
    B.5.5Fax number+440131449 8889
    B.5.6E-mailann.scott@aptivsolutions.com
    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 namePEG-Irinotecan
    D.3.2Product code NKTR-102
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 848779-32-8
    D.3.9.2Current sponsor codeNKTR-102
    D.3.9.3Other descriptive namePEG-irinotecan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Metastatic or Unresectable Locally Advanced Platinum-Resistant Ovarian Cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the female organ (ovaries)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For the Primary Efficacy Population:
    •To determine the objective response rate (ORR) with NKTR 102 given on a q21d treatment schedule (Arm B) in patients with platinumresistant ovarian cancer and who have received prior PLD therapy in a platinum-resistant setting or who are otherwise unable to receive
    further PLD therapy.
    E.2.2Secondary objectives of the trial
    For each additional patient population:
    • To determine the ORR of NKTR-102

    For each patient population:
    •To estimate duration of response (DoR)
    • To estimate progression-free survival (PFS) with NKTR-102
    • To estimate overall survival (OS) with NKTR-102
    • To determine the clinical benefit rate of NKTR-102
    • To determine the cancer antigen 125 (CA-125) response with NKTR-102
    • To characterize the safety profile of NKTR-102
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be enrolled in this study:
    1. Provide signed and dated informed consent prior to study-specific screening procedures
    2. ≥ 18-year old females
    3. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
    4. Inoperable metastatic or unresectable locally advanced disease
    5. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of last dose of most recent platinum drug
    6.Platinum-resistant patients who have progressed after receiving PLD
    therapy in a platinum-resistant setting or who are otherwise unable to
    receive PLD therapy
    7. Patients must have measurable disease as defined by RECIST (version 1.0) in at least 1 lesion not previously irradiated
    8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    9. Patients must have adequate organ and bone marrow function at the Screening visit as defined below:
    a. Absolute neutrophil count ≥ 1,500/mm3 without myeloid growth factor support for 21 days preceding the lab assessment,
    b. White blood cell (WBC) count ≥ 3,000/mm3 without myeloid growth factor support for 21 days preceding the lab assessment,
    c. Platelet count ≥ 100,000/mm3, without transfusion within 7 days preceding the lab
    assessment,
    d. Hemoglobin ≥ 9 g/dL, without transfusion support ,
    e. Total bilirubin ≤ 2 mg/dL,
    f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN if the presence of liver metastasis is confirmed), and
    g. Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min.
    10. Women of childbearing potential must have a negative serum pregnancy test at Screening
    11. Women of childbearing potential must agree to use at least 2 forms of contraception, 1 of which includes a barrier method (male condom) by the male partner, during the study drug treatment period and for at least 8 months after the last dose of the study drug
    12. Patients must be able and willing to comply with the study visit schedule and study procedures
    E.4Principal exclusion criteria
    1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
    nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1, and have not recovered to Grade 1 toxicity as defined by NCI-CTCAE version 3.0 (with any grade of alopecia allowed) and Grade 0 diarrhea associated with previous treatments irrespective of the interval from the last treatment
    2.Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2 weeks prior to Day 1 of Cycle 1. Minor surgery does not include placement of a venous access device or
    simple ascites drain
    3. Administration of any of the following cytochrome P450 3A4 (CYP3A4) inducers or inhibitors: phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John’s Wort, ketoconazole, neuromuscular agents or atazanavir sulfate within 2 weeks prior to the first day of study drug treatment
    4. Patients who are receiving biologic agents including antibodies (eg, bevacizumab,
    trastuzumab, etc.) as well as investigational agents, within 28 days of Cycle 1 Day 1
    5. Patients who have received any treatment with a camptothecin derivative (eg, irinotecan, topotecan, SN38 investigational agents, etc.)
    6. Known or suspected central nervous system metastases
    7. Pregnant or lactating
    8. Other malignancy within the past 5 years except for any of the following: early-stage (≤ IB),
    low-grade (FIGO Grade 1 or 2) endometrial cancer, non-melanoma skin cancer, or carcinoma in situ of the cervix
    9. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
    10. Patients with a history of hypersensitivity to other PEGylated drugs
    11. Patients with inflammatory bowel disease (eg, Crohn’s disease and ulcerative colitis), unresolved bowel issues (eg, diverticulitis, ileitis, colitis, complete bowel obstruction etc.) or patients with chronic or acute gastrointestinal disorders with diarrhea as a major symptom
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    • ORR as determined by RECIST version 1.0, hereafter referred to as RECIST (Therasse et al., 2000)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The End-of-Treatment visit is to occur at 30 ± 3 days after last dose of study drug. Approximately every 3 months following the End-of-Treatment visit, patients will be contacted to assess progression, OS, receipt of subsequent anti-cancer therapy, and resolution of all toxicity attributable to study drug. Progression during follow-up will only be assessed if the patient did not progress by RECIST (version1.0) during the study drug treatment period and only the first
    progression will be reported. Receipt of subsequent anti-cancer therapy will only be assessed until the first anti-cancer therapy is reported. Quarterly follow-up will continue until death, withdrawal by patient, physician decision, lost to follow-up, or study terminated by Sponsor.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    •Duration of response (DoR)
    • Best overall response as determined by Gynecologic Cancer Intergroup
    (GCIG) criteria (http://www.gcig.igcs.org/CA-125.html)
    • CA-125 response rate as determined by having achieved a ≥ 50% reduction
    in serum levels of CA-125 from a pre-treatment level of at least twice the
    upper limit of normal (ULN) noted within 2 weeks of starting treatment
    according to the GCIG criteria and time to maximum CA-125 response
    • Clinical benefit rate (patients with CR, PR, or SD [≥ to 3 months]) by
    RECIST (version 1.0)
    • PFS
    • OS
    • 6-month and 1-year survival rate
    • Incidence and duration of toxicities, with severity grading according to
    National Cancer Institute Common Criteria for Adverse Events (NCICTCAE)
    version 3.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    The End-of-Treatment visit is to occur at 30 ± 3 days after last dose of study drug. Approximately every 3 months following the End-of-Treatment visit, patients will be contacted to assess progression, survival status, receipt of subsequent anti-cancer therapy, and resolution of all toxicity attributable to study drug. Progression during follow-up will only be assessed if the patient did not progress by RECIST (version1.0) during the study drug treatment period and only the first
    progression will be reported. Receipt of subsequent anti-cancer therapy will only be assessed until the first anti-cancer therapy is reported. Quarterly follow-up will continue until death, withdrawal by patient, physician decision, lost to follow-up, or study terminated by Sponsor.
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    alternative dosing schedule
    E.8.2.4Number of treatment arms in the trial2
    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 EEA10
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    United Kingdom
    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
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 190
    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)
    Normal treatment for condition
    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 Decision2009-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-30
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