Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-005074-12
    Sponsor's Protocol Code Number:20070411
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-005074-12
    A.3Full title of the trial
    A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination with AMG 479 in Subjects with Advanced, Refractory Solid Tumors.
    --------------------------------------------------------
    Estudio abierto de fase 1b/2 con escalada de dosis de AMG 655 en combinación con AMG 479 en sujetos con tumores sólidos refractarios y avanzados.
    A.4.1Sponsor's protocol code number20070411
    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 SponsorAmgen 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 nameAMG 655
    D.3.2Product code AMG 655
    D.3.4Pharmaceutical form Intravenous 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.3.9.2Current sponsor codeAMG 655
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 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 nameAMG 479
    D.3.2Product code AMG 479
    D.3.4Pharmaceutical form Intravenous 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.3.9.2Current sponsor codeAMG 479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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
    Part 1: Advanced, treatment-refractory solid tumors
    Part 2: Advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, ovarian cancer, or sarcoma.
    ------------------------------------------------------------
    Parte 1:tumores sólidos refractarios y avanzados.
    Parte 2:Cáncer de pulmón no microcítico avanzado (CPNM), cáncer colorrectal (CRC), cáncer pancreático, cáncer de ovario o sarcoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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: To identify a dose of AMG 655 in combination with AMG 479 that is safe and
    tolerated as determined by the incidence of dose limiting toxicity (DLT).
    Part 2: To estimate the efficacy, as measured by the objective response rate (ORR;
    confirmed complete response [CR] and partial response [PR] using modified Response Evaluation Criteria in Solid Tumors [RECIST]) of AMG 655 in combination with AMG 479.
    E.2.2Secondary objectives of the trial
    Part 1:
    - To evaluate the safety and tolerability of AMG 655 in combination with AMG 479.
    - To evaluate anti-AMG 655 antibody formation and anti-AMG 479 antibody formation.
    - To evaluate the pharmacokinetics (PK) of AMG 655 and of AMG 479.
    Part 2:
    - To estimate the efficacy of AMG 655 in combination with AMG 479, as measured by
    time to response, duration of response, and progression-free survival (PFS).
    - To evaluate the safety and tolerability of AMG 655 in combination with AMG 479.
    - To evaluate anti-AMG 655 antibody formation and anti-AMG 479 antibody formation.
    - To evaluate the PK of AMG 655 and of AMG 479.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease Related
    - Part 1: Histologically or cytologically confirmed, locally advanced or metastatic,
    treatment-refractory solid tumors
    - Part 2: Histologically or cytologically confirmed, locally advanced or metastatic
    - NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens)
    - CRC (up to 2 prior treatment regimens)
    - Pancreatic cancer (up to 1 prior treatment regimen)
    - Ovarian cancer (up to 2 prior treatment regimens), or
    - Sarcoma (up to 2 prior treatment regimens)
    - according to cohort availability
    - Part 2: Measurable disease according to modified RECIST (at least 1 measurable
    lesion)
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix G)
    - Life expectancy &#8805; 3 months
    Demographic.
    - Women or men &#8805; 16 years of age
    Ethical
    - Before any study-specific procedure, the appropriate written informed consent must
    be obtained (Section 12.1)
    Laboratory
    Within 7 days before enrollment, the following test results must be obtained:
    - Hematological function, as follows:
    - Hemoglobin &#8805; 9 g/dL
    - Absolute neutrophil count (ANC) &#8805; 1.5 x 109/L
    - Platelet count &#8805; 100 x 109/L
    (without transfusion &#8804; 14 days prior to enrollment)
    - Renal function, as follows:
    - Serum creatinine &#8804; 2 x ULN
    - Hepatic function, as follows:
    - Aspartate aminotransferase (AST; SGOT) &#8804; 2.5 x ULN
    ( 5 x ULN if attributable to liver metastases)
    - Alanine aminotransferase (ALT; SGPT) &#8804; 2.5 x ULN
    (&#8804; 5 x ULN if attributable to liver metastases)
    - Total Bilirubin &#8804; 1.5 x ULN
    (&#8804; 3 x ULN for subjects with UGT1A1 promoter polymorphism ie, Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to enrollment)
    - Coagulation:
    - Partial thromboplastin time (PTT) &#8804; 1.3 x ULN
    - International normalized ratio (INR) &#8804; 1.5,
    - Amylase &#8804; 2 x ULN
    - Lipase &#8804; 2 x ULN
    - Adequate glycemic function, for subjects with known diabetes (Type 1 or 2), as
    follows:
    - Must be controlled with a glycosylated hemoglobin (HgbA1c) of &#8804; 8.0%
    - Documented fasting blood sugars &#8804; 160 mg/dL. Diabetic subjects who have
    recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations &#8804; 160 mg/dL may be considered regardless of HgbA1c value, if per investigator discretion they are considered to have adequate glycemic function
    - Negative pregnancy test within 3 days prior to enrollment (females of child-bearing potential only)
    General
    - Plan to begin protocol specific therapy &#8804; 7 days after enrollment
    E.4Principal exclusion criteria
    Disease Related
    - Presence of uncontrolled central nervous system (CNS) disease:
    - Subjects with CNS metastases that are both definitively treated and
    stably controlled are eligible if all of the following apply:
    (1) definitive therapy has been administered (surgery and/or radiation therapy);
    (2) there is no additional treatment planned for brain metastases;
    (3) the subject is clinically stable; and
    (4) the subject is off corticosteroids or on a stable dose of corticosteroids for at
    least 14 days prior to enrollment.
    - Part 2: Any prior or synchronous other malignancy, except:
    - Malignancy treated with curative intent and with no known active disease present
    for &#8805; 3 years before enrollment and considered to be at low risk for recurrence by
    the treating physician
    - Adequately treated non-melanoma skin cancer or lentigo maligna without
    evidence of disease
    - Adequately treated cervical carcinoma in situ without evidence of disease
    - Prostatic intraepithelial neoplasia without evidence of prostate cancer
    Cancer Therapy
    - Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or
    approved anticancer proteins/antibodies therapy &#8804; 28 days before enrollment,
    except:
    - In Part 1, patients may continue approved hormonal therapy as medically
    indicated
    - Unresolved toxicity(ies) from prior anti-cancer therapy, which may increase the risks
    associated with study participation
    - Prior treatment with death receptor agonists (including but not limited to
    rhApo2L/TRAIL [AMG 951], apomab, mapatumumab, lexatumumab, CS-1008)
    - Prior treatment with IGF receptor antagonists (including but not limited to
    CP-751,871, MK0646, AVE1642 or IMC-A12)
    - Patients may not have received prior radiotherapy to > 25% of the bone marrow.
    Radiation must have been concluded &#8805; 14 days prior to enrollment. Patients must
    have recovered from all potential side effects and must be clinically stable.
    Medications/ Treatments
    - Therapeutic anticoagulation treatment within 7 days prior to enrollment.
    - Prophylactic anticoagulation of venous access devices (eg, with low-dose
    coumadin [1-2 mg/day] or low-dose heparin) is allowed, provided PTT and INR
    eligibility criteria are met.
    - Recent infection requiring systemic anti-infective treatment that was completed
    - 14 days before enrollment (with the exception of uncomplicated urinary tract
    infection or upper respiratory tract infection)
    Medical Conditions
    - Major surgical procedure &#8804; 28 days before enrollment, or not yet recovered from
    prior major surgery
    - Minor surgical procedure (eg, open biopsy) &#8804; 7 days before enrollment, or not yet
    recovered from prior minor surgery.
    Note: uncomplicated placement of vascular access device, fine needle aspiration,
    thoracocentesis or paracentesis &#8805; 3 days prior to enrollment is acceptable
    - History of bleeding diathesis
    - Pulmonary embolism or arterial/venous thromboembolism within 6 months
    - Known positive test for human immunodeficiency virus, hepatitis C virus or acute or
    chronic hepatitis B infection
    - Any clinically significant medical or psychiatric condition, co-morbid disease,
    addictive disorder, or laboratory abnormality (eg, cardiovascular disease or chronic
    obstructive pulmonary disease), which may increase the risks associated with study
    participation or study treatments or could interfere with the safe delivery of study
    treatment or increase risk of toxicity
    - Subject has any kind of disorder that compromises the ability of the subject to give
    written informed consent and/or to comply with study procedures
    General
    - Subject is currently enrolled in or has not yet completed at least 30 days since
    ending other investigational device or drug study(s), or subject is receiving other
    investigational agent(s)
    - Subject previously enrolled in this study
    - Subject of child-bearing potential is evidently pregnant (eg, positive human chorionic
    gonadotropin test) or is breast feeding
    - Woman or man with partner of childbearing potential not consenting to use adequate
    contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm
    plus condom), or abstinence during the course of the study and for 3 months after
    the last study drug administration for women, and 6 months for men
    - Subject has known hypersensitivity to any of the products to be administered during the study
    - Subject is not able to tolerate IV drug infusions
    - Subject unwilling or unable to comply with study requirements
    - Subject will not be available for follow-up assessments
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as DLT
    Part 2: ORR (confirmed CR and PR, by modified RECIST)
    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 No
    E.6.11Pharmacogenomic No
    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
    1b/2
    E.7.2Therapeutic exploratory (Phase II) No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 end of the clinical study will be defined as the date when all subjects have
    completed the long-term follow-up period, have withdrawn from study or have died (until a maximum 36 months from the date the last subject was enrolled), whichever is earlier.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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 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 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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 108
    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 Decision2009-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-10
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA