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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2010-022950-17
    Sponsor's Protocol Code Number:IMGN0007
    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:2011-08-01
    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 number2010-022950-17
    A.3Full title of the trial
    A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine (IMGN901) in Combination with Carboplatin/Etoposide in Patients with Advanced Solid Tumors including Extensive Stage Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early study to test IMGN901 with carboplatin and etoposide for treating adult patients with certain types of cancer including small cell lung cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberIMGN0007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01237678
    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 SponsorImmunoGen, 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 supportImmunoGen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunoGen Inc
    B.5.2Functional name of contact pointClinical Operations Manager
    B.5.3 Address:
    B.5.3.1Street Address830 Winter Street
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number1781895 0600
    B.5.5Fax number1781895 0612
    B.5.6E-mailclinicalops@immunogen.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/792
    D.3 Description of the IMP
    D.3.1Product nameLorvotuzumab mertasine
    D.3.2Product code IMGN901
    D.3.4Pharmaceutical form Concentrate 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.3.8INN - Proposed INNLorvotuzumab mertansine
    D.3.9.2Current sponsor codeIMGN901
    D.3.9.3Other descriptive nameMaytansinoid DM1-Conjugated Humanized 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) 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 Yes
    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
    Phase 2: small cell lung cancer (extensive-stage disease)
    E.1.1.1Medical condition in easily understood language
    Treatment of certain types of cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10041058
    E.1.2Term Small cell carcinoma of the lung
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy followed by
    IMGN901 alone as first-line treatment for patients with extensive stage small cell lung cancer (SCLC-ED).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine the safety and tolerability of IMGN901 in combination with carboplatin/etoposide
    chemotherapy followed by IMGN901 alone versus carboplatin/etoposide chemotherapy and to assess the immunogenicity of IMGN901 in combination with carboplatin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients ≥18 years old at the time of signing Informed Consent
    2. Diagnosis
    • Patients with histologically or cytologically confirmed SCLC and extensive disease as defined by the Veterans Administration Lung Cancer Group
    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    4. Prior therapy
    • No prior systemic chemotherapy for the treatment of SCLC
    • Previous radiotherapy, including cranial irradiation, is allowed if < 30% of marrow-bearing bones were irradiated and if radiotherapy was completed at least 7 days prior to enrollment and the patient has recovered or stabilized from all adverse effects of prior radiotherapy
    5. Major surgery (this does not include placement of vascular access device or tumor biopsies) must be completed 4 weeks prior to Day 1
    6. Patients must have at least one measurable lesion per RECIST 1.1 guidelines for solid tumors.
    7. Patients must have the following laboratory values:
    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L (1500/mm3)
    • Platelets ≥100.0 x 109/L (100,000/mm3)
    • Hemoglobin (Hgb) ≥9 g/dL
    • Serum total bilirubin ≤1.5 x ULN (upper limit of normal)
    • AST (SGOT) and ALT (SGPT) ≤2.5 x ULN, except for patients with tumor involvement of the liver who must have AST and ALT ≤5 x ULN
    • Serum creatinine ≤1.5 x ULN or 24-hour creatinine clearance ≥60 mL/min
    • Amylase and lipase must be ≤1.5 x ULN
    8. Patients must be willing and able to adhere to the study visit schedule and other protocol requirements
    9. Patients or a legally authorized representative must understand and voluntarily sign an Informed Consent
    10. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use 2 contraceptive methods (e.g., oral, parenteral, or implantable hormonal contraceptive; tubal ligation; intra-uterine device;
    barrier contraceptive with spermicide; partner's latex condom or vasectomy). WCBP must agree to follow these requirements for at least 4 weeks after the last dose of study drug
    11. WCBP must have a negative pregnancy test prior to the first dose of study treatment
    12. Male patients must agree to use a latex condom even if he has had a successful vasectomy and continue to follow these requirements for at least 4 weeks following the last dose of study drug
    13. Predicted survival of 3 months or more
    E.4Principal exclusion criteria
    1. Concurrently receiving other anti-neoplastic treatment (e.g. chemotherapy, investigational therapy or immunotherapy including steroid therapy)
    2. Grade ≥2 neurotoxicity
    3. Any serious medical condition including laboratory abnormalities, or psychiatric disorder that in the opinion of the Investigator places a patient at unacceptable risk if he/she were to participate in the study
    4. Clinically relevant active infection including known active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, varicella-zoster virus (shingles) or cytomegalovirus infection or any other known concurrent infectious disease which, in the judgment of the Investigator, would make a patient inappropriate for enrollment into this study
    5. Significant cardiac disease such as recent myocardial infarction (≤6 months prior to Day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg ), uncontrolled cardiac arrhythmias, severe aortic stenosis, or ≥ grade 3 cardiac toxicity following prior chemotherapy
    6. History of neurologic disease such as multiple sclerosis or other demyelinating disease; paraneoplastic neurologic syndrome such as Eaton-Lambert syndrome, encephalomyelitis or sensory neuropathy;
    central nervous system (CNS) injury with residual neurological deficit; or has a history of hemorrhagic or ischemic stroke within the last 6 months
    7. Patients with CNS metastases excluded unless previously treated with surgery or radiation and on stable, decreasing or no steroids. Patients with asymptomatic CNS metastases are eligible unless requiring steroids, anticonvulsants or other treatments to manage their CNS disease.
    8. Patients with uncontrolled carcinoid syndrome (flushing, uncontrolled diarrhea, labile blood pressure)
    9. Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids
    10. Patients with previous history of hypersensitivity or anaphylactic reaction to IMGN901 or any of its excipients
    11. Patients with previous history of hypersensitivity to etoposide or any component of its formulation
    12. Patients with previous history of allergic reaction to platinum-containing compounds
    13. Prior active malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer
    14. Patients with a history of chronic pancreatitis or metastatic disease involving the pancreas that has been associated with an increased amylase and/or lipase
    15. WCBP who are pregnant or lactating
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 2: 2 years after enrollment of last patient
    E.5.2Secondary end point(s)
    1. Overall survival
    2. PFS
    3. TTP
    4. ORR
    5. Toxicity and tolerability
    6. OS
    7. PK parameters (for patients enrolled prior to Amendment 4)
    8. Presence of HAHA and HADA in arm 1
    9. Measurement of cytokines
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 2 years after enrollment of last patient
    2. 6 months
    3. At scheduled visits
    4. At scheduled visits
    5. At scheduled visits
    6. 12 months
    7. Days 1, 2, 3, 8, 9 cycle 1, Days 1, 2, 3 cycle 4
    8. Day 1 cycles 1, 4, 10, 15
    9. Pre-dose day 1 & 8 of cycle 1 of Phase 2
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Canada
    Spain
    United States
    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
    2 years after the enrollment of the last patient.
    This is to allow sufficient time for follow-up on survival
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    E.8.9.2In all countries concerned by the trial months6
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 160
    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)
    Standard of care
    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 Decision2011-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-12
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