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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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:2015-000896-28
    Sponsor's Protocol Code Number:391401
    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:2015-09-21
    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 number2015-000896-28
    A.3Full title of the trial
    A Phase 2a Randomized, Open-label Study to Assess the Safety, Tolerability, and Efficacy of BAX69 in Combination with 5-FU/Leucovorin or Panitumumab versus Standard of Care in Subjects with Metastatic Colorectal Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early development study of BAX69 in combination of three anti-tumor madications, compared to standard of care in patients with metastatic colorectal cancer.
    A.4.1Sponsor's protocol code number391401
    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 SponsorBaxalta Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxalta Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxalta US Inc
    B.5.2Functional name of contact pointSara Coulter
    B.5.3 Address:
    B.5.3.1Street Address650 East Kendall Street, 5th Floor
    B.5.3.2Town/ cityCambrigde, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617588 8127
    B.5.6E-mailsara.coulter@baxalta.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLeucovorin
    D.3.2Product code BAX69
    D.3.4Pharmaceutical form 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 INNBAX69
    D.3.9.1CAS number BAX69
    D.3.9.2Current sponsor codeBAX69
    D.3.9.3Other descriptive nameBAX69
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Metastatic colorectal cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the large intestine with metastases in other organs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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
    1. To determine the RP2D of imalumab in combination with 5-FU/LV or panitumumab (Part 1)
    2. To compare progression-free survival (PFS) between imalumab in combination with 5-FU/LV for subjects with KRAS mut and/or NRAS mut tumors or in combination with panitumumab for subjects with KRAS wt and NRAS wt tumors, versus SoC (investigator choice) as third or fourth treatment line (Part 2)
    E.2.2Secondary objectives of the trial
    1. To compare overall response rate (ORR) and clinical benefit rate (CBR) in subjects treated at RP2D with imalumab in combination with 5- FU/LV or panitumumab versus SoC (investigator choice) as third or fourth treatment line.
    2.To compare OS of subjects who received imalumab in combination with 5-FU/LV or panitumumab versus SoC (investigator choice) as third or fourth treatment line
    3. To assess the safety and tolerability of imalumab in combination with 5-FU/LV or panitumumab
    4. To characterize the PK of imalumab in combination with 5-FU/LV or panitumumab
    5. To compare quality of life (QoL) of subjects who received imalumab in combination with 5-FU/LV or panitumumab versus SoC (investigator choice) as third or fourth treatment line
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    optional genetic biomarker study
    E.3Principal inclusion criteria
    1. Provision of a signed informed consent
    2. Male and female subjects 18 years of age and older at the time of screening
    3. Subjects who progressed after receiving at least 2, but no more than 3, prior cancer drug therapy treatment lines including SoC in the metastatic setting.
    4. Anticipated life expectancy > 3 months at the time of screening
    5. Weight between 40 kg and 180 kg
    6. Histologically or cytologically confirmed diagnosis of CRC
    7. Metastatic CRC not amenable to surgical resection
    8. Known KRAS, NRAS mutation status (if unknown status for either of these genes, and no archival tissue is available, a fresh tumor biopsy will be obtained)
    9. At least 1 measurable lesion as defined by RECIST v1.1
    10. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
    11. Adequate hematological function, defined as:
    a. Platelet count ≥ 100,000/μL
    b. Prothrombin time and activated partial thromboplastin time (aPTT) < 1.5 times the upper limit of normal (ULN)
    c. Absolute neutrophil count ≥ 1,000/μL
    d. Hemoglobin ≥ 9 g/dL, without the need for transfusion in the 2 weeks prior to screening
    12. Adequate renal function, defined as serum creatinine ≤ 2.0 times ULN and creatinine clearance > 50 mL/min or eGFR estimated glomerular filtration rate > 50ml/min/1.73 m2
    13. Adequate liver function, defined as:
    a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN for subjects without liver metastases, or ≤ 5 times ULN in the presence of liver metastases
    b. Bilirubin ≤ 2.0 times ULN, unless subject has known Gilbert’s syndrome
    14. Adequate venous access
    15. For female subjects of childbearing potential, the subject presents with a negative serum pregnancy test at screening and agrees to employ 2 forms of adequate birth control methods, including at least 1 barrier method (eg, diaphragm with spermicidal jelly or foam, or [for male partner] condom) throughout the course of the study and for at least 90
    days after the last administration of imalumab. In addition, these birth control methods must be continued for at least 180 days after last administration of 5-FU in subjects who receive this treatment. Secondary contraceptive measures could be either birth control pills, patches, or intrauterine devices
    16. For male subjects, they must agree to use adequate contraceptive measures including at least 1 barrier method (eg, condom with spermicidal jelly or foam and [for the female partner] diaphragm with spermicidal jelly or foam, birth control pills/patches, or intrauterine device) and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of imalumab. In addition, these birth control methods must be continued for at least 180 days after last administration of 5-FU in subjects who receive this treatment
    17. Subject is willing and able to comply with the requirements
    of the protocol
    E.4Principal exclusion criteria
    1. Known central nervous system metastases
    2. Prior malignancy(s) within the past 3 years, with the exception of curatively treated basal or
    squamous cell carcinoma of the skin, locally advanced prostate cancer, ductal carcinoma in situ of
    breast, in situ cervical carcinoma and superficial bladder cancer
    3. Prior treatment with panitumumab for subjects with KRAS/ wt and NRAS tumors
    4. Known history of keratitis, ulcerative keratitis, or severe dry eye in subjects with KRAS wt and NRAS wt tumors.
    5. Residual adverse event (AE) from previous treatment > Grade 1, except neuropathy and alopecia.
    6. Myocardial infarction within 6 months prior to Cycle 1 Day 1 (C1D1), and/or prior diagnoses of
    congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable
    cardiac arrhythmia requiring medication; and/or the subject is at risk for polymorphic ventricular
    tachycardia (eg, hypokalemia, family history, or long QT syndrome)
    7. Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood
    pressure ≥ 100 mmHg confirmed upon repeated measures
    8. Left ventricular ejection fraction (LVEF) < 40% as determined by echocardiogram performed at
    screening or within 90 days prior to C1D1
    9. Left ventricular ejection fraction (LVEF) < 40% as determined by (echocardiogramECHO)/multigated acquisition scan (MUGA) performed at screening or within 90 days prior to C1D1.
    10. Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted
    therapy, retinoid therapy, or hormonal therapy), within 4 weeks (< 28 days) prior to C1D1
    11. Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy,) within 4 weeks (< 28 days) prior to C1D1
    12. Major surgery within 4 weeks (< 28 days) prior to C1D1
    13. Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints (osteoarthritis is not exclusionary)
    14. Active infection involving IV antibiotics within 2 weeks prior to C1D1
    15. Known history of, or active hepatitis B virus (HBV,) and/or hepatitis C virus (HCV), or active tuberculosis.
    16. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease
    17. Subject has received a live vaccine within 4 weeks (< 28 days) prior to C1D1
    18. Known hypersensitivity to any component of recombinant protein production by Chinese Hamster Ovary (CHO) cells
    19. Exposure to an investigational product or investigational device in another clinical study within 4 weeks (< 28 days) prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
    20. Subject is breastfeeding or intends to begin breastfeeding during the course of the study
    21. Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study
    22. Subject is a family member or employee of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Outcome Measure
     Occurrence of DLTs - Dose Limiting Toxicity (Part 1)
    Primary Efficacy Outcome Measure
     PFS, defined as time between treatment initiation and tumor progression (per RECIST v1.1) or death from any cause, with censoring of subjects who are lost to follow-up or withdraw consent (Part 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Time to appearance of signs of DLT
    2. Time to disease progression or death
    E.5.2Secondary end point(s)
    Immunogenicity Outcome Measures
     Occurrence of binding and/or neutralizing anti-imalumab antibodies
     Incidence and severity of infusion reactions after imalumab
    Safety Outcome Measures
     Occurrence of serious adverse events (SAEs) and/or TEAEs, regardless of causality or relationship to study drug and coded according to NCI CTCAE v4.03
     Other safety measurements: physical or instrumental examinations,
    electrocardiograms (ECGs), vital signs, and clinically relevant changes in
    instrumental examinations or laboratory values
    Efficacy Outcome Measures
     Response evaluation according to RECIST v1.1
     OS, defined as time from randomization to death of any cause
    Pharmacokinetic Outcome Measures
    Imalumab plasma PK will be characterized using a population PK modeling approach, in combination with data from other studies. Results of population PK modeling will be reported in a separate report.
    Quality of Life Outcome Measures
    The QoL outcome measure uses the EORTC QLQ-C30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity:
    - lab samples taken at visits
    - observations after BAX69 infusions
    Safety:
    AE/SAE monitoring is done at every visit
    Efficacy:
    Response evaluation is done at every visit
    PK:
    From PK lab samples
    QoL:
    From questionnaires taken at the dedicated visits
    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 Yes
    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
    Immunogenicity
    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 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) 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 concerned0
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days12
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 90
    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)
    After completion of the clinical trial participants will be treated according current state of the art therapy recommendations.
    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 Decision2016-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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