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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2010-019821-32
    Sponsor's Protocol Code Number:20090508
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-24
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2010-019821-32
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer
    A.3.2Name or abbreviated title of the trial where available
    TRINOVA-1
    A.4.1Sponsor's protocol code number20090508
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01204749
    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 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical trials
    B.5.3 Address:
    B.5.3.1Street Address240 Cambridge Science Park, Milton road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB4 0WD
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailMedinfoInternational@amgen.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 nameAMG 386
    D.3.2Product code AMG 386
    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 INNAMG 386
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeAMG 386
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 600
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder 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
    Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers
    E.1.1.1Medical condition in easily understood language
    Fallopian Tube Cancer
    Ovarian Cancer
    Primary Peritoneal Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    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 determine if paclitaxel plus AMG 386 is superior to paclitaxel plus placebo as measured by progression-free survival (PFS), defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications or death from any cause in subjects with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers
    E.2.2Secondary objectives of the trial
    To determine if paclitaxel plus AMG 386 is superior to paclitaxel plus placebo as measured by overall survival (OS) in subjects with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Disease Related
    • Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
    − Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology are excluded
    − Subjects with borderline ovarian cancer, ie, subjects with low malignant potential tumors, are excluded
    − Subjects with clear cell or mucinous histology are excluded
    • Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy
    • Radiographically documented disease progression either on or following the last dose of prior chemotherapy regimen for epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
    • Radiologically evaluable disease per RECIST 1.1 with modifications
    − There must be radiographically visible tumor
    − Subjects with only ascites or pleural effusion are excluded
    • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapy administered after surgical or non-surgical assessment.
    − Subjects are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease.

    Demographic
    • Female 18 years of age or older at the time the written informed consent is obtained
    • Subjects of child-bearing potential who have not undergone a bilateral
    salpingo-oophorectomy and are sexually active must consent to use an accepted and effective non-hormonal method of contraception [ie, double barrier method (eg, condom plus diaphragm)] from signing the informed consent through 6 months after last dose of study drug

    General
    • Generally well-controlled blood pressure with systolic blood pressure
    ≤ 140 mmHg AND diastolic blood pressure ≤ 90 mmHg prior to randomization.
    The use of anti-hypertensive medications to control hypertension is permitted.
    GOG Performance Status of 0 or 1 (see Appendix H)
    • Life expectancy ≥ 3 months (per investigator opinion)
    • Subject plans to begin protocol-directed therapy within 7 days from randomization

    Laboratory
    • Adequate organ and hematological function as evidenced by the following laboratory
    studies prior to randomization:
    − Hematological function (see protocol for definition)
    − Renal function (see protocol for definition)
    − PTT or aPTT ≤ 1.5 x ULN per institutional laboratory range and INR ≤ 1.5
    − Hepatic function (see protocol for definition)
    − Nutritional (see protocol for definition)
    E.4Principal exclusion criteria
    Disease Related
    • Subjects who have received more than 3 previous regimens of anti-cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers
    • Subjects who have received paclitaxel as consolidation therapy, maintenance, or monotherapy are excluded
    • Subjects with primary platinum-refractory disease
    − Subjects with recurrence or progression during the first 6 cycles or < 6 months after the beginning of the first-line platinum-based chemotherapy are excluded
    • Subjects with platinum-free interval (PFI) > 12 months from their last platinum-based therapy
    • Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
    − If all sites of disease have been irradiated, documented progression must have occurred in at least 1 site of disease subsequent to the radiation therapy
    • Previous abdominal or pelvic radiotherapy
    • History of arterial or venous thromboembolism within 12 months prior to randomization
    • History of clinically significant bleeding within 6 months prior to randomization
    • History of central nervous system metastasis
    Medications
    • Has not yet completed a 21 day washout period prior to randomization for any previous anti-cancer systemic therapies (30 days for prior bevacizumab)
    • Enrolled in or has not yet completed at least 30 days (prior to randomization) since ending other investigational device or drug, or currently receiving other investigational treatments
    • Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 ≥ Grade 2 in severity except alopecia
    • Known active or ongoing infection (except uncomplicated urinary tract infection [UTI]) within 14 days prior to randomization
    • Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
    • Treatment within 30 days prior to randomization with strong immune modulators including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, and lenalidomide
    General Medical
    • Clinically significant cardiovascular disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent
    • Subjects with a history of prior malignancy, except:
    − Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by treating physician
    − Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
    − Adequately treated cervical carcinoma in situ without evidence of disease
    Prior myeloablative high-dose chemotherapy with allogeneic or autologous stem cell (or bone marrow) transplant
    • Major surgery within 28 days prior to randomization or still recovering from prior surgery
    • Minor surgical procedures, except placement of tunneled central venous access device within 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minor surgical procedure.
    • History of allergic reactions to bacterially-produced proteins
    • Hypersensitivity to paclitaxel or drugs using the vehicle cremophor
    • Pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding or planning to become pregnant within 6 months after the end of treatment
    • Subject has known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
    • Any condition which in the investigator’s opinion makes the subject unsuitable for study participation
    • Any uncontrolled concurrent illness or history of any medical condition that may interfere with the interpretation of the study results
    • Non-healing wound, ulcer (including gastrointestinal) or fracture
    • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
    • Subjects believed to be a higher than average risk of bowel perforation. This includes symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, subjects requiring total parenteral nutrition and continuous hydration
    • Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 peripheral neuropathy > grade 1 at randomization
    See protocol for further criteria
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression-free survival (PFS). PFS is defined as the time from the date of randomization to the earliest of the dates of first objective disease progression per RECIST 1.1 with modifications or death from any cause. Subjects not meeting these criteria by the analysis data cutoff date will have their PFS time censored at their last evaluable radiologic disease assessment date. For the purposes of the primary analysis, the determination of radiologic disease progression per RECIST 1.1 with modifications will be based on investigator assessments.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis is planned when a minimum of 510 PFS events (per investigator review) have been observed
    E.5.2Secondary end point(s)
    • Overall Survival
    • Objective Response Rate (ORR)
    • Duration of response (DOR)
    • CA-125 response rate per GCIG and change in CA-125
    • Incidence of adverse events and significant laboratory abnormalities
    • Pharmacokinetics of AMG 386 (Cmax and Cmin)
    • Incidence of the occurrence of anti-AMG 386 antibody formation
    • Patient reported HRQOL and ovarian cancer related symptoms using FACT-O
    • Overall health status using EQ-5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    The OS primary analysis will occur after 600 OS events have been observed. It is anticipated that it will occur approximately 44 months after the first subject is randomized.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    Croatia
    Czech Republic
    Estonia
    France
    Greece
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Malaysia
    Mexico
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Slovenia
    South Africa
    Spain
    Sweden
    Switzerland
    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
    The end of study is defined as the last protocol specified follow-up supporting all planned analyses of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    E.8.9.2In all countries concerned by the trial months0
    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: 651
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 268
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 445
    F.4.2.2In the whole clinical trial 919
    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 Decision2010-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-16
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 23 15:33:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA