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    Summary
    EudraCT Number:2008-006035-12
    Sponsor's Protocol Code Number:SG035-0004
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-12
    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 ConcernedGermany - PEI
    A.2EudraCT number2008-006035-12
    A.3Full title of the trial
    A pivotal study of SGN-35 in treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL)
    A.4.1Sponsor's protocol code numberSG035-0004
    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 SponsorSeattle Genetics, 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/595
    D.3 Description of the IMP
    D.3.1Product nameSGN-35
    D.3.2Product code SGN-35
    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.3.9.1CAS number 914088-09-8
    D.3.9.2Current sponsor codeSGN-35
    D.3.9.3Other descriptive namecAC10-VC-SGD1006
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Yes
    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) Yes
    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
    Relapsed or refractory systemic anaplastic large cell lymphoma (ALCL)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065864
    E.1.2Term Anaplastic large-cell lymphoma, primary systemic type
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this trial is to determine the antitumor efficacy of single-agent SGN-35 (1.8 mg/kg administered intravenously every 3 weeks), as measured by the overall objective response rate in patients with relapsed or refractory systemic anaplastic large cell lymphoma following front-line chemotherapy (CHOP or equivalent).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are the following:
    • To assess duration of tumor control, including duration of response and progression-free survival (PFS)
    • To assess survival
    • To assess the safety and tolerability of SGN-35
    • To assess the pharmacokinetics of SGN-35

    Furthermore, additional objectives are the following:
    • To assess disease-related symptoms
    • To explore the correlation of potential biomarkers with clinical outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for this study, patients must meet all of the following inclusion criteria:

    1. Patients with relapsed or refractory systemic ALCL who have previously received front-line chemotherapy (CHOP or multi-agent anthracycline- or anthracenedione-based chemotherapy).
    2. Documented anaplastic lymphoma kinase (ALK) status.
    3. Histologically-confirmed CD30-positive disease by central review; tissue from the most recent post-diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. If such tissue is not available, a fresh biopsy must be obtained. See section 7.4 of the protocool for details.
    4. Age greater than or equal to 18 years.
    - Patients of age greater than or equal to 12 years may be enrolled at US and Canadian sites.
    5. Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT, as assessed by the site radiologist.
    6. At least ONE of the following as evidence of relapsed or refractory systemic ALCL:
    a) Histologically-documented CD30-positive systemic ALCL from a biopsy obtained at least 4 weeks subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents.
    b) Interval tumor growth documented between two successive CT evaluations with the second evaluation occurring at least 4 weeks after delivery of any radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents.
    c) FDG-avidity by PET in a new tumor mass on CT that is unlikely to have an alternative explanation.
    d) Recurrent FDG-avidity by PET in a previously identified FDG-avid tumor mass on CT that had become negative.
    e) FDG-avid tumor mass by PET in conjunction with systemic ALCL related symptoms (e.g., pruritus, B symptoms (fever, night sweats, or weight loss >10%)), after infectious causes have been excluded.
    7. Received any previous ASCT at least 12 weeks (3 months) prior to the first study dose and/or completed any previous treatment with radiation, chemotherapy, biologics and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35. Patients must have completed any prior immunotherapy (e.g. monoclonal antibody) or radioisotopic therapy at least 12 weeks prior to the first dose of SGN-35 in the absence of clear disease progression.
    8. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    9. The following required baseline laboratory data: absolute neutrophil count (ANC) ≥1000/μL, platelets ≥50,000/μL, bilirubin ≤1.5X upper limit of normal (ULN) or ≤3X ULN for patients with Gilbert’s disease, serum creatinine ≤1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN.
    10. Females of childbearing potential must have a negative serum or urine β-hCG pregnancy test result within 7 days prior to the first dose of SGN-35. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
    11. Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.
    12. Patients or their legally authorized representative must provide written informed consent.
    E.4Principal exclusion criteria
    If a patient is positive any of the following exclusion criteria, the patient will not be eligible for study:

    1. Previous treatment with SGN-35.
    2. Previously received an allogeneic transplant.
    3. Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
    4. Congestive heart failure, Class III or IV, by the NYHA criteria.
    5. History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
    6. Known cerebral/meningeal disease.
    7. Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35.
    8. Current therapy with other systemic anti-neoplastic or investigational agents.
    9. Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of SGN-35.
    10. Women who are pregnant or lactating.
    11. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
    12. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the overall objective response rate (ORR) per an independent review facility (IRF).
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploration of correlation of potential biomarkers with clinical outcomes
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Yes
    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
    The end of the trial will be the date of final clinical database lock of the trial. It is anticipated that this will occur 60 months after the last patient completes receiving study medication. Patients will be followed for long-term survival data to assess one of the secondary endpoints, but none of these patients will be on study medication.
    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 months60
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months60
    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) No
    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 Information not present in EudraCT
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 55
    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)
    The treatment or medical care of patients requiring ongoing therapy for anaplastic large cell lymphoma after the trial has ended will revert to the normal standard of care for patients with this disease. The provision of a plan for the consecutive treatment and medical care of the concerned people following the end of the clinical trial required according to Section 4.1.4 of the European Commission Guideline (ENTR/F2/BL D(2003), rev.2) is therefore not applicable.
    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 Decision2009-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-31
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