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    Summary
    EudraCT Number:2008-005578-12
    Sponsor's Protocol Code Number:08-PIR-06
    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 number2008-005578-12
    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 Locally Advanced Cervical Cancer
    A.4.1Sponsor's protocol code number08-PIR-06
    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 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 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 namePEG-Irinotecan
    D.3.2Product code NKTR-102
    D.3.4Pharmaceutical form Powder 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 codeNKTR-102
    D.3.9.3Other descriptive namePEG-Irinotecan
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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) 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
    Patients with Metastatic or Locally Advanced Cervical 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 10008229
    E.1.2Term Cervical cancer
    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 (ORR) with NKTR-102 given on one of two schedules: once every 14 days (q14d) and once every 21 days (q21d)
    E.2.2Secondary objectives of the trial
    For each schedule:
    • To estimate progression-free survival (PFS) with NKTR-102
    • To evaluate overall survival (OS) rates with NKTR-102
    • To characterize the safety profile of NKTR-102
    • To monitor the pharmacokinetics of NKTR-102 and its metabolites in a subset of patients
    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 years old
    3) Histologically or cytologically confirmed cervical cancer
    4) Inoperable metastatic or locally advanced disease
    5) Patients must not have received prior chemotherapy given in the metastatic / locally advanced setting; one prior concomitant chemotherapy regimen is permissible provided it did not include a camptothecin
    6) Measurable disease as defined by RECIST in at least one lesion not previously irradiated
    7) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    8) Patients must have adequate organ and bone marrow function at the screening visit as defined below
    a Absolute neutrophil count ≥ 1,500/mm3 without GCSF support for 21 days preceding the lab assessment
    b White blood cell (WBC) count ≥ 3,000/mm3 without GCSF 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 within 7 days preceding the lab assessment
    e Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (≤ 5 × ULN if the presence of liver metastasis is confirmed). Bilirubin must be within normal limits.
    f Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min
    g Albumin ≥ 3 g/dL (30 g/L)
    9) Patients who are women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the predose visit of each cycle
    10) Patients who are women of childbearing potential, or men whose female partners are of childbearing potential, must agree to use at least 2 forms of contraception, 1 of which includes a barrier method by the male partner, during the treatment period and for at least 3 months after the last dose of the study drug
    11) Patients must be able and willing to comply with the study visit schedule and study procedures
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will not be permitted entry to the study:
    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 must have, as determined by the Investigator, recovered to CTC Grade 1 toxicity (any CTC grade of alopecia is allowed) 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
    3) Administration of any of the following cytochrome P450 3A4 (CYP3A4) inducer or inhibitor: phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St. John’s Wort, ketoconazole, neuromuscular agents or atazanavir sulfate (Section 8.6.2) within 2 weeks prior to the first day of study drug treatment
    4) Patients who have been treated with an investigational agent within 4 weeks prior to Day 1 of Cycle 1
    5) Prior treatment with a camptothecin
    6) Concomitant use of biological agents including growth factors
    7) Known or suspected central nervous system metastases
    8) Pregnant or lactating
    9) Other malignancy within the past 3 years except for any of the following: non-melanoma skin cancer, or any another malignancy with no evidence of recurrence for more than 5 years
    10) Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
    11) Patients with a history of hypersensitivity to other PEGylated drugs
    12) Patients with inflammatory bowel disease
    13) Patients with unresolved bowel disease
    E.5 End points
    E.5.1Primary end point(s)
    For each schedule:
    • Objective response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST)
    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 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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months27
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 70
    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 Decision2009-01-09
    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 trial2011-10-20
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