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    Summary
    EudraCT Number:2015-002222-40
    Sponsor's Protocol Code Number:U31287-A-U203
    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:2015-07-29
    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 number2015-002222-40
    A.3Full title of the trial
    Randomized, Placebo-Controlled, Double Blind Phase 2 Study of Patritumab (U3-1287) in Combination with Cetuximab plus Platinum Based Therapy in First Line Setting in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate patritumab in combination with cetuximab plus platinum-containing therapies in patients with head and neck cancer
    A.4.1Sponsor's protocol code numberU31287-A-U203
    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 SponsorDaiichi Sankyo , 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 supportDaiichi Sankyo Pharma Development
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportDaiichi Sankyo Company Limited
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo , Inc.
    B.5.2Functional name of contact pointClinical Trial Information Contact
    B.5.3 Address:
    B.5.3.1Street Address399 Thornall Street
    B.5.3.2Town/ cityEdison
    B.5.3.3Post codeNJ 08837
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 732 590 5000
    B.5.5Fax number+1 732-906-5690
    B.5.6E-maileu_cta@dsi.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 namePatritumab
    D.3.2Product code U3-1287
    D.3.4Pharmaceutical form Powder 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 INNpatritumab
    D.3.9.1CAS number 1262787-83-6
    D.3.9.2Current sponsor codeU3-1287
    D.3.9.3Other descriptive nameAnti-HER3 Monoclonal Antibody
    D.3.9.4EV Substance CodeSUB59906
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Carboplatin 10 mg/ml Intravenous Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCarboplatin 10 mg/ml Intravenous Infusion
    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 INNCARBOPLATIN
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Erbitux 5 mg/ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCetuximab 5mg/ml solution for infusion
    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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Cisplatin 1mg/ml Concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospria UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCisplatin 1mg/ml Concentrate for Solution for Infusion
    D.3.2Product code Cisplatin
    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 INNCisplatin
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) No
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboLyophilisate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Squamous Cell Carcinoma of the Head and Neck
    E.1.1.1Medical condition in easily understood language
    Head and Neck Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.

    E.2.2Secondary objectives of the trial
    • Evaluate overall survival (OS)

    • Evaluate overall response rate (ORR)

    • Refine the cutoff between heregulin high and low expression based on clinical data from this study

    • Assess the population PK of patritumab in subjects with SCCHN

    • Assess the PK parameters of serum cetuximab and platinum concentrations when cetuximab and cisplatin or carboplatin (platinum-based therapy) are coadministered with patritumab in a sub group (n = 30) of subjects

    • Evaluate the incidence of human antihuman antibody (HAHA) formation (anti-patritumab antibodies)

    • Evaluate the safety and tolerability of the combination of patritumab + cetuximab + platinum-based therapy in first-line treatment of subjects with SCCHN
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult subjects ≥18 years old

    2. Histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx,and larynx

    3. Heregulin expression level is required
    - Samples must be taken from subjects who have recurrent or metastatic disease. These samples can be from either rec/met archived or fresh biopsy samples
    - No cancer treatment between time of biopsy and submission of sample
    - Surgical or core needle biopsy is acceptable
    - Fine-needle aspiration or cytology is not acceptable for biopsies

    4. Human papilloma virus (HPV) status or p16 (surrogate for HPV) is required. These results must come from tumor tissue. These results may be obtained from either a local lab or samples sent to the central lab
    - HPV or p16 status can be from any tumor biopsy material from initial diagnosis

    5. Measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1

    6. Eastern Cooperative Oncology Group performance status 0 or 1

    7. Hematological function, as follows:
    - Absolute neutrophil count ≥ 1.5 x 109/L
    - Platelet count ≥ 100 x 109/L
    - Hemoglobin ≥ 10 g/dL

    8. Renal function, as follows:
    - Estimated serum creatinine clearance (mL/min) or GFR ≥ 60 mL/min for cisplatin and ≥ 30 mL/min for carboplatin

    9. Hepatic function, as follows:
    - Aspartate aminotransferase ≤ 2.5 x upper limit of normal (ULN) (if liver metastases are present, < 5 x ULN)
    - Alanine aminotransferase ≤ 2.5 x ULN (if liver metastases are present, < 5 x ULN)
    - Alkaline phosphatase ≤ 2.0 x ULN (if bone or liver metastases are present, < 5 x ULN)
    - Bilirubin ≤ 1.5 x ULN

    10. Prothrombin time or partial thromboplastin time ≤ 1.5 x ULN

    11. Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to enrollment (where demanded by local regulations, test may be required within 72 hours prior to enrollment)

    12. Adult subjects of child-bearing potential must agree to use double-barrier contraceptive measures. Two of the following precautions must be used: bilateral vasectomy, bilateral tubal ligation, intrauterine device (IUD), combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine hormone-releasing system (IUS), condom with spermicide, abstinence. These contraception measures must be used for the entire duration of the study and for 6 months after the last study dose is received

    13. Subjects must be willing and able to comply with schedule visits, treatment plan, laboratory tests, and other study procedures

    14. Provided written informed consent(s)
    E.4Principal exclusion criteria
    1. Left ventricular ejection fraction (LVEF) <50%

    2. Prior EGFR targeted regimen

    3. No HRG expression result

    4. No HPV or p16 status

    5. Prior anti-HER3 therapy

    6. Prior chemotherapy for recurrent/metastatic disease

    7. Anti-cancer therapy between biopsy and submission of sample

    8. Presence of squamous cell tumors of the nasopharynx

    9. History of other malignancies, except adequately treated non melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years

    10. Known history of brain metastases or active brain metastases

    11. Uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)

    12. Clinically significant electrocardiograph (ECG) findings

    13. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina, or unstable cardiac arrhythmia requiring medication

    14. Platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment

    15. Therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment. Radiation treatment to all sites of measureable disease unless progression is documented after radiation

    16. Participated in clinical drug trials within 4 weeks before study drug treatment. Current participation in other investigational procedures

    17. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known HIV infection, or active hepatitis B or C infection or undergoing medical treatment for infection

    18. Uncontrolled type 1 or 2 diabetes mellitus

    19. Known hypersensitivity or allergic reaction against any of the components of the trial treatment

    20. Pregnant, breastfeeding, or unwilling/unable to use acceptable contraception

    21. Residual toxicities ≥ Grade 1 from previous therapies that the Investigator determines would exclude participation

    22. Psychological, social, familial, or geographical factors that would interfere with study participation or follow-up

    23. Committed to an institution by virtue of an order issued either by judicial or administrative authorities

    24. Employee or immediate relative of an employee of the sponsor, CRO, the study center, or their affiliates or partners

    25. Receiving yellow fever vaccine or live attenuated vaccines (for subjects receiving carboplatin)

    26. Presence of hemorrhagic tumors (for subjects receiving carboplatin)

    27. Prophylactic use of phenytoin or fosphenytoin (for subjects receiving cisplatin or carboplatin)
    E.5 End points
    E.5.1Primary end point(s)
    1) Progression free survival (PFS) in the HRG high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) The time from the date of randomization to the earlier of the dates of the first objective
    documentation of radiographic disease progression (per RECIST v1.1 as assessed by investigator) or death due to any cause.
    E.5.2Secondary end point(s)
    2) Overall survival (OS)

    3) Objective response rate (ORR)

    4) PK parameters of serum cetuximab and platinum concentrations when cetuximab and cisplatin or carboplatin are coadministered with patritumab in a subgroup (n=30) of subjects

    5) Population PK of patritumab

    6) Incidence of HAHA formation (anti-patritumab antibodies)

    7) Safety and tolerability of the combination of patritumab + cetuximab + platinum-based therapy in first-line treatment of subjects with SCCHN
    E.5.2.1Timepoint(s) of evaluation of this end point
    2) Date of randomization to death due to any cause
    2) Subjects alive at time of data cut off for OS analysis will be censored at the last contact date at which subject is known to be alive

    3) Proportion of subjects with the best ORR of CR or PR regardless of whether it is confirmed or unconfirmed

    4) Refer to schedule of events

    5) Refer to schedule of events

    6) Refer to schedule of events

    7) Refer to schedule of events
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Until all subjects have died or a minimum of 13 months after the last subject is randomized whichever comes first
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 79
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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)
    Subjects receiving clinical benefit from treatment will be offered the opportunity to continue therapy with patritumab and cetuximab in the extension phase of this 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 Decision2015-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-21
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