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    Summary
    EudraCT Number:2005-005547-26
    Sponsor's Protocol Code Number:MDX060-04
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-04-10
    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 number2005-005547-26
    A.3Full title of the trial
    An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients with Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    Not Available
    A.4.1Sponsor's protocol code numberMDX060-04
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Available
    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 SponsorMedarex, 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 nameiratumumab
    D.3.2Product code MDX-060
    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 use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNiratumumab
    D.3.9.1CAS number 640735-09-7
    D.3.9.2Current sponsor codeMDX-060
    D.3.9.3Other descriptive namehuman anti-CD30 monoclonal antibody
    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 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) 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 Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma (ALCL)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective response rate at Day 50 in patients with relapsed or refractory classic systemic anaplastic large cell lymphoma (csALCL) or primary cutaneous anaplastic large cell lymphoma (pcALCL) treated with MDX-060.
    E.2.2Secondary objectives of the trial
    1. Characterize progression-free survival
    2. Determine response duration
    3. Characterize the effect of MDX-060 on health-related Quality of Life
    4. Evaluate patients with pcALCL using an adaptation of the NCI Response Criteria for Non-Hodgkin's Lymphoma (NHL)
    5. Characterize the immunogenicity of MDX-060
    6. Characterize the safety of MDX-060
    7. Determine the best objective response rate during the Maintenance Phase of the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient or guardian must have read, understood, and provided written informed consent after the nature of the study has been fully explained. Patients 12 through 17 years old must also provide written assent
    2. Confirmed diagnosis of ALCL (excluding HIV-associated ALCL)
    3. Patients with csALCL must have a histologically confirmed diagnosis of CD30+ ALCL and confirmation of anaplastic lymphoma kinase status (positive or negative)
    4. Patients with csALCL must have failed or relapsed following second line chemotherapy or relapsed or failed following autolougus stem cell transplant. Patients who are not candidates for stem cell transplant, exhibitit chemo-resistant disease, or refuse further chemotherapy may also be included.
    5. Patients with pcALCL must have progressed after treatment with local radiation therapy or surgical excision or failed systemic therapy with a single agent or multi-agent regimen
    6. Patients with pcALCL must have a histologically confirmed diagnosis of CD30+ ALCL within the past 12 months
    7. ECOG Performance Status of 0 to 2
    8. Patients must have bidirectionally measurable disease
    9. At least 4 weeks since the last chemotherapy or radiation therapy prior to dosing of MDX-060 and have recovered from any toxicity associated with such treatment or returned to baseline
    10. At lease 12 years of age
    11. Life expectancy of 12 weeks or more
    12. Screening laboratory valuse must meet criteria
    13. Women must either be post-menopausal for at least 1 year, surgically incapable of bearing children, or utilizing a reliable form of contraception. All women must have a negative pregnancy test during screening
    14. Men must agree to the use of male contraception for the duration of the study
    15. Patients on corticosteroids must be tapered off the medication 2 weeks prior to the first MDX-060 administration and remain off corticosteroids until Day 365
    E.4Principal exclusion criteria
    1. Previous treatment with any anti-CD30 antibody
    2. History of allogenic transplantation
    3. Any tumor lesion 10cm or greater in diameter
    4. Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease-free for at least 5 years is permissible
    5. Any significant active or chronic infection
    6. Prior known serum positivity for HIV antibodies, hepatitis B antigenemia, or hepatitis C veremia, as determined at screening
    7. Treatment with investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening
    8. Apparent active or latent tuberculosis infection
    9. Patients who are pregnant or nursing
    10. Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events
    11. Concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy
    12. Patients with mycosis fungoides
    13. Patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate at Day 50 as based on an adaptation of the NCI Response Criteria for Non-Hodgkin's Lymphoma (NHL) for patients with csALCL and will be based on the Physician's Global Assessment (PGA) for patients with pcALCL.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    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) 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.8.4.1Number of sites anticipated in Member State concerned4
    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 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
    The study will terminate 1 year after the last patient has recieved the last dose of MDX-060 or when all patients have progressed and are off study, whichever is earlier.
    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 Yes
    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) Yes
    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 2006-04-10. 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 45
    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)
    Provided in the protocol.
    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 Decision2006-09-25
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-05-24
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