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    Summary
    EudraCT Number:2009-011101-16
    Sponsor's Protocol Code Number:P04722
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-09-24
    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 number2009-011101-16
    A.3Full title of the trial
    Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination with Different Treatment Regimens in Subjects with Advanced Solid Tumors (Phase 1b/2; Protocol No. P04722)
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberP04722
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorSchering-Plough Research Institute, A Division of Schering Corporation
    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 nameanti-IGF-1R monoclonal antibody
    D.3.2Product code SCH 717454
    D.3.4Pharmaceutical form Concentrate for 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 INNRobatumumab
    D.3.9.1CAS number 934235-44-6
    D.3.9.2Current sponsor codeSCH 717454
    D.3.9.3Other descriptive nameanti-IGF-1R
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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
    Colorectal Adenocarcinoma, Non-small Cell Lung Cancer, Gastric Adenocarcinoma, Her2+ Breast Cancer, Renal Cell Cancer, Pancreatic Adenocarcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10001150
    E.1.2Term Adenocarcinoma gastric
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10038407
    E.1.2Term Renal cell cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10051971
    E.1.2Term Pancreatic adenocarcinoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10052360
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1-Determine a safe and well-tolerated dose of SCH 717454 in combination with different treatment regimens in subjects with solid tumors.

    Part 2-Determine tumor response rate for SCH 717454 as defined by RECIST, in combination with different treatment regimens.
    E.2.2Secondary objectives of the trial
    Evaluate AE profile, PK parameters, determine incidence of anti-SCH 717454 antibodies, and evaluate peripheral blood levels of IGF-I, IGF-II, IGFBP-2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be ≥18 years of age. A subject may be of either sex & of any race/ethnicity
    2. Part 1: Subject must have a histologically or cytologically confirmed advanced malignant solid tumor
    Part 2: Subject must have a histologically or cytologically confirmed, with measurable disease (as defined by RECIST), advanced, malignant solid tumor type as specified below for which treatment in the given regimen is appropriate:
    Regimen A: Colorectal Adenocarcinoma
    Regimen B: Non-small Cell Lung Cancer
    Regimen C: Gastric Adenocarcinoma
    Regimen D: Her2+ Breast Cancer
    Regimen E: Renal Cell Cancer
    Regimen F: Pancreatic Adenocarcinoma
    3. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2
    4. Subject must have adequate organ function within 3 wks prior to 1st study drug administration as evidenced by:
    a) Absolute neutrophil count ≥1.5 x 10 to the 9th power /L
    b) Hemoglobin ≥90 g/L (≥80 g/L for subjects w/renal cell carcinoma)
    c) Platelet count ≥100 x 10 to the 9th power/L
    d) Serum creatinine ≤1.5 x upper limit of normal (ULN) or a calculated creatinine clearance >60 mL/min
    e) Total bilirubin <1.5 x ULN, except for subjects w/Gilbert’s disease,
    f) Alkaline phosphatase, aspartate aminotransferase (AST)/serum glutamic-oxalacetic transaminase (SGOT) & alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <3 x ULN, or, in the presence of documented liver metastases, ≤5 x ULN
    5.(Only subjects assigned to receive Epirubicin [Regimen C]): Each subject must have a left ventricular ejection fraction (LVEF) of ≥50% by Multi Gated Acquisition Scan (MUGA) or echocardiogram
    6. Subject must be able to adhere to dose & visit schedules
    7. Female subject (& male subject whose female partner also provides written informed consent to provide information regarding pregnancy) of childbearing potential, must agree to use a medically accepted method of contraception, or abstain from sexual intercourse, during Screening, while receiving protocol-specified medication, & for 2 months after stopping the medication. Females who are not currently sexually active must also consent to use one of these accepted methods of contraception should they become sexually active while participating in the study. Medically accepted methods of contraception include: systemic hormonal contraceptive & surgical sterilization (eg, hysterectomy or tubal ligation). Condoms (male & female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, & medically prescribed intrauterine devices may be acceptable according to local regulations
    Note: Vasectomy of the partner is not considered sufficient contraception, & one of the methods listed above must be used. A male subject must agree to use a medically accepted method of contraception (see above) or abstain from sexual intercourse during the trial & for 2 months after stopping the medication. Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period
    8. To participate in the pharmacogenomic analysis, the subject must be willing to give written informed consent for the pharmacogenomic testing & able to adhere to dose & visit schedules
    E.4Principal exclusion criteria
    1. Subject must not have known treated or untreated leptomeningeal metastasis or a metastatic central nervous system lesion. Subjects w/a clinical history of central nervous system metastases or cord compression may be eligible, provided they have been definitively treated & are clinically stable, after discussion w/sponsor
    2. Subject must not have a history (w/in 5 yrs prior to first study drug administration) of another malignancy excluding adequately treated Stage 1 or Stage 2 basal/squamous cell carcinoma of the skin or carcinoma in situ of the cervix or other adequately treated malignancy for which the subject has been disease free for ≥5 yrs)
    3. Subject must not have received any treatment listed in the Table stated in Protocol syopsis more recently than the indicated washout period prior to Day 1 Cycle 1
    4. A subject must not continue to receive any treatment listed in the Table stated in Protocol synopsis during the current trial
    5. Subject must not have received prior therapy w/any anti-IGF-1R monoclonal antibody
    6. Subject must not have received radiation therapy w/in 2 wk prior to 1st study drug administration
    7. Subject must not have received radiation therapy to >25% of his/her total bone marrow during his/her lifetime
    8. Subject must not have undergone major surgery w/in 3 weeks prior to first study drug administration
    9. Subject must not have known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy. If the investigator is suspicious that a subject has one of these diseases, they should test to confirm prior to Day 1 Cycle 1
    10.Subject must not have known active hepatitis B or C. If the investigator is suspicious that a subject has one of these diseases, they should test to confirm prior to Day 1 Cycle 1
    11. Subject must not have any serious or uncontrolled infection
    12. Subject must not have uncontrolled diabetes mellitus, defined as a hemoglobin A1C of ≥7.5% at Screening in a subject w/known diabetes mellitus (subjects w/elevated glucose values at Screening should be evaluated for diabetes mellitus)
    13. Subject must not have had any of the following w/in 6 months prior to 1st study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder
    14. Subject must not have persistent, unresolved CTC for AEs (CTCAE) Grade ≥2 drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes, & loss of libido) associated w/previous treatment (inclusion of subjects w/persistent neuropathy or hearing loss Grade ≥2 due to previous treatment require discussion with the sponsor)
    15. Subject must not be participating in any other clinical study w/a potentially therapeutic agent or must not have received another investigational product w/in 21 days prior to Day 1 Cycle 1
    16. Subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study
    17. (Only for subjects assigned to receive Irinotecan, Everolimus, & Erlotinib [Regimens A, E, & F]): A subject must not have concomitant use drugs & herbal preparations known to induce or inhibit cytochrome P450 3A4 enzymes, p-glycoprotein, or adenosine triphosphate (ATP)-binding cassette (ABC) transporters
    18. (Only for subjects assigned to receive Paclitaxel [Regimen B]): A subject must not have concomitant use of any drugs or herbal preparations known to induce or inhibit cytochrome P450 3A4 or 2C8 enzymes
    19. (Only for subjects assigned to receive Epirubicin [Regimen C]): A subject must not have a lifetime anthracycline exposure at Screening that would preclude a minimum of 2 cycles of anthracycline on this study. The lifetime cumulative dose of anthracycline must be ≥450 mg/m2 in subjects who receive anthracycline as a bolus injection without a cardioprotectant. A subject must not have concomitant use of cimetidine
    20 (Only for subjects assigned to receive Cetuximab containing regimens [Regimen A]): A subject must not have evidence of mutated-K-ras
    21. Subject must not have a history of hypersensitivity reactions to any of the therapeutic agents in the assigned treatment regimen
    22. Female subject must not be breast-feeding, pregnant, intending to become pregnant, or have a positive pregnancy test at Screening (false positive pregnancy tests [eg, due to tumor production of human chorionic gonadotrophin], must have additional clinical documentation that the subject is not pregnant)
    E.5 End points
    E.5.1Primary end point(s)
    Determine a safe and generally well-tolerated dose of SCH 717454 to be administered in combination with other treatment agents in subjects with advanced solid tumors. Summaries of dose limiting toxicities (DLTs), all adverse events (AEs), and laboratory results will be provided for the MAD
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Maximum Tolerated Dose
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA25
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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.1.3Elderly (>=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 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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)
    According to 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 Decision2009-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-06-07
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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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