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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2004-000607-17
    Sponsor's Protocol Code Number:SG030-0003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-31
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2004-000607-17
    A.3Full title of the trial
    A Phase II Multi-Dose Study of SGN-30 (anti-CD30 mAb) in Patients with
    Refractory or Recurrent Hodgkin’s Disease or Anaplastic Large Cell Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    -
    A.4.1Sponsor's protocol code numberSG030-0003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number-
    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 Information not present in EudraCT
    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 name--
    D.3.2Product code SGN-30
    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 drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN--
    D.3.9.1CAS number --
    D.3.9.2Current sponsor codeSGN-30
    D.3.9.3Other descriptive namechimeric AC-10
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Refractory or Recurrent Hodgkin’s Disease or Anaplastic Large Cell Lymphoma

    MedDRA version 6.0
    PT=Hodgkin's Disease NOS recurrent=10020256
    PT=Hodgkin's Disease NOS refractory=10020257
    PT=Anaplastic large cell lymphoma T- and null-cell types recurrent=1002229
    PT=Anaplastic large cell lymphoma T- and null-cell types refractory=1002230
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.0
    E.1.2Level PT
    E.1.2Classification code 10020256
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this phase II study are as follows:
    - To determine the objective response rate of SGN-30 in two study groups, patients with HD and patients with ALCL
    - To determine the duration of response in patients with HD and in patients with ALCL
    - To investigate the toxicity profile of SGN-30 at a dose of 6 mg/kg
    E.2.2Secondary objectives of the trial
    The secondary objectives of this phase II study are as follows:
    - To provide preliminary estimates of disease-free and overall survival in patients with HD and in patients with ALCL
    - To determine the immunogenicity of SGN-30 at a dose of 6 mg/kg
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients must have refractory or recurrent HD or refractory or recurrent ALCL.
    2. Patients must have histologically confirmed CD30+ HD or ALCL. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy tissue of relapsed disease.
    3. Patients must have bidimensional measurable disease on physical examination or radiologic evaluation.
    4. Patients must have failed systemic chemotherapy either as initial therapy for advanced disease or as salvage therapy after initial radiotherapy for early stage disease.
    5. Patients may have received no more than four treatments (radiation, chemotherapy, and/or biologics) prior to enrollment.
    6. Patients may have received no more than one stem cell transplantation.
    7. Patients who have undergone stem cell transplantation must have received at least one therapy post-transplantation. Patients who have not had stem cell transplantation must be considered ineligible or refuse treatment by stem cell transplantation. Treatments associated with bone marrow transplant, such as mobilization and conditioning, will be considered as one regimen.
    8. Patients must have completed radiotherapy and/or chemotherapy at least four weeks prior to enrollment. Any prior treatment with nitrogen mustard agents, melphalan, or BCNU must have been completed at least six weeks prior to enrollment.
    9. Patients must have an ECOG performance status of less than or equal to 2 and a life expectancy > three months.
    10. Patients must be at least 18 years of age.
    11. Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
    12. Females of childbearing potential must have a negative beta-HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study.
    13. Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient’s chart.
    14. Required baseline laboratory data:
    - Absolute neutrophil count greater than or equal to 1,250/mm3
    - Platelet count greater than or equal to 75,000/mm3
    - Serum bilirubin less than or equal to 1.5 times ULN
    - Serum creatinine less than or equal to 1.5 times ULN
    - BUN less than or equal to 1.5 times ULN
    E.4Principal exclusion criteria
    1. Patients with primary cutaneous ALCL
    2. Patients who have been treated previously with any anti-CD30 antibody
    3. Patients who have received any mAb unless a recent serum testing reveals no antibody titer and no evidence of human anti-murine antibodies (HAMA) or human anti-chimeric antibodies (HACA) in the peripheral circulation
    4. Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment
    5. Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
    6. Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ
    7. Patients with known active viral, bacterial, or systemic fungal infection; patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
    8. Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
    9. Patients with symptomatic brain metastases requiring treatment
    10. Patients who are pregnant or breastfeeding
    11. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment
    12. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent
    E.5 End points
    E.5.1Primary end point(s)
    For Hodgkin’s Disease patients, objective tumor response (Partial Remission, Complete Remission, Stable Disease or Progressive Disease) will be determined based on the Cotswolds criteria (J Clin Oncol 1989; 7(11):1630-6).

    For ALCL patients, objective tumor response (Partial Remission, Complete Remission, Stable Disease or Progressive Disease) will be determined based on the Cheson criteria (J Clin Oncol 1999; 17(4):1244-53).

    Initial responses will be determined four weeks after the final SGN-30 infusion. Time to response (PR+CR), duration of response, progression-free survival, and overall survival will be summarized for evaluable patients.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Patients who responded on day 64 are followed up at 6-8 weeks to determine if they are still responding. Responders are followed at 12 week intervals until disease progression when they are followed for survival until death.

    The study will complete when either 20 ALCL patients have been enrolled with 3 or fewer objective responses or when a total of 40 ALCL patients have been enrolled.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-08-31. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 80
    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 Decision2005-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
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