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    Summary
    EudraCT Number:2018-001006-28
    Sponsor's Protocol Code Number:20170770
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-09-11
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-001006-28
    A.3Full title of the trial
    PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    Study of Romiplostim for CIT in in Adult Subjects with NSCLC, Ovarian Cancer, or Breast Cancer
    A.4.1Sponsor's protocol code number20170770
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03937154
    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 Biotechnologia Sp. z o.o.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street Addressul. PuĊ‚awska 145
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-715
    B.5.3.4CountryPoland
    B.5.4Telephone number+48 22 5813001
    B.5.6E-mailmedinfo-pol@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 Yes
    D.2.1.1.1Trade name Nplate
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROMIPLOSTIM
    D.3.9.1CAS number 267639-76-9
    D.3.9.3Other descriptive nameROMIPLOSTIM
    D.3.9.4EV Substance CodeSUB27756
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer
    E.1.1.1Medical condition in easily understood language
    lung cancer, ovarian cancer, or breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10070907
    E.1.2Term Ovarian cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10070908
    E.1.2Term Ovarian cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006201
    E.1.2Term Breast cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006202
    E.1.2Term Breast cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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 the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy
    E.2.2Secondary objectives of the trial
    -to compare the treatment effect of romiplostim with that of placebo on the depth of platelet nadir
    -to compare the treatment effect of romiplostim with that of placebo on the time to first platelet response
    -to compare the treatment effect of romiplostim with that of placebo on the incidence of > grade 2 bleeding events
    -to compare the treatment effect of romiplostim with that of placebo on overall survival
    -to compare the treatment effect of romiplostim with that of placebo on the incidence of platelet transfusions
    -to compare the treatment effect of romiplostim with that of placebo on the proportion of patients achieving platelet response
    -overall safety of romiplostim
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
    2. Males or females > 18 years of age at signing of the informed consent.
    3. Documented active stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer
    (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease.
    •patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery.
    4. Subjects must be receiving cancer treatment with 21- or 28-day cycles, using one of the following carboplatinum-based combination chemotherapy regimens: carboplatin/gemcitabine based, carboplatin/pemetrexed based, carboplatin/liposomal doxorubicin based or carboplatin/taxane based (which includes either paclitaxel, nab-paclitaxel, or docetaxel) or single agent chemotherapy regimen with any of the above mentioned drugs. Use of combination regimens with one of the above regimens is permitted with (1) anti-angiogenic agents (such as bevacizumab); (2) targeted therapy (such as anti-epidermal growth factor agents or anti- human epidermal growth factor receptor 2) or (3) immune checkpoint inhibitors. Cycle duration is based on intervals between day 1 of chemotherapy cycles (overlapping with carboplatin intervals) every 21 or 28 day cycles for single agent
    regimens.
    OR
    Subjects must have CIT from a non-protocol chemotherapy regimen,
    planning to start treatment with one of the above protocol chemotherapy
    regimens which has been delayed . 1 week due to CIT.
    5. Subjects must have a platelet count < 75 x 109/L on day 1 of the study.
    6. Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively.
    7. Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
    8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    E.4Principal exclusion criteria
    1Acute lymphoblastic leukemia.
    2Acute myeloid leukemia.
    3Any myeloid malignancy.
    4Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and
    cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm.
    5Myeloproliferative disease.
    6Multiple myeloma.
    7Within 4 months prior to enrol., any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV),symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction.
    8Major surgery <28 days or minor surgery < 3 days prior to enrol.
    9New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening.
    10History of arterial thrombotic events (eg, myocardial ischemia,
    tranient ischemic attack, or stroke) within 6 mon. prior to screening
    11Evidence of active infection within 2 weeks prior to the first dose of study treatment
    12Known human immunodeficiency virus infection with any detectable viral load at screening
    13Known active of chronic hepatitis C or hepatitis B infection.
    14In addition to the conditions listed in exclusion criteria 201 through 206, secondary malignancy within the past 5 years except:
    •Adeq. treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    •Adeq. treated cervical carcinoma in situ without evidence of disease.
    •Adeq. treated breast ductal carcinoma in situ without evidence of disease
    •Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    •Adeq. treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
    Malignancy treated with curative intent and with no known active disease present for >3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    15Thrombocytopenia due to another etiology other than CIT
    16Any combined modality regimen containing radiation therapy or surgery occurring concomitantly with neo-adjuvant chemotherapy or where radiation therapy is planned during the cycle preceding the 3 planned on-study cycles of chemotherapy.
    17Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor,eltrombopag,recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.
    18Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another
    investigational device or drug study(ies). Other inv. procedures while participating in this study are excluded.
    19Anemia (hemoglobin <8 g/dL) on the day of initiation of inv. product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines.
    20Neutropenia (absolute neutrophil count <1 x 109/L) on the day of initiation of investigational product as assessed by local labs.
    21Abnormal renal function with creatinine clearance <30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local
    lab during screening. If local lab results are not available use central lab results.22. Abnormal liver function as assessed by central lab during
    screening.
    23Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 months after treatment (and chemotherapy) disc.
    24Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 7 months after treatment(and chemotherapy) discontinuation.
    25Males unwilling to use contraception* (male condom or sexual abstinence) or their female partner(s) of childbearing potential who are unwilling to use a highly effective method of contraception during treatment (and chemotherapy) and for .an add 7 months after; treatment (and chemotherapy) discontinuation. *If the male's sole partner is of non childbearing potential, he is not required to use additional forms of contraception during the study.
    26Sub. has known sensitivity to any of the products to be administered during dosing.
    27Sub. likely to not be available to complete/comply with all protocol-required study visits or procedures.
    28History or evidence of any other clinically sign. disorder,condition or disease that would pose a risk to sub. safety or interfere with the study eval, procedures or completion.
    29Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for an additional 7 mon. after treatment (and chemotherapy)discontinuation.
    30Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an add. 7 mon. after treatment (and chemotherapy) disc.
    E.5 End points
    E.5.1Primary end point(s)
    no thrombocytopenia-induced modification of any myelosuppressive agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced
    modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early.
    E.5.2Secondary end point(s)
    - the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
    -the time to first platelet response, defined by platelet count 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
    -the duration-adjusted event rate of grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale
    -overall survival
    -platelet transfusion(s) during the treatment period
    -achieving a platelet count 100 x 109/L at any time after study day 1 to week 4 (i.e. 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days
    -adverse events, including treatment-emergent adverse events, fatal
    adverse events, serious adverse events,and clinically significant changes in laboratory values
    -anti-romiplostim antibodies and antibodies to thrombopoietin (TPO)
    -myelodysplastic syndromes and secondary malignancies
    E.5.2.1Timepoint(s) of evaluation of this end point
    -The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early.

    -When the last subject in the trial completes LTFU at 1 year after the last dose of investigational product, the final database will be locked and unblinded for the final analysis. In the final analysis, the secondary endpoints assessment, and all the exploratory endpoints will be evaluated
    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) 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Argentina
    Chile
    Colombia
    Peru
    Ukraine
    Brazil
    Canada
    Mexico
    Russian Federation
    United States
    Austria
    Bulgaria
    Greece
    Hungary
    Poland
    Portugal
    Romania
    Spain
    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 (EOS) date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (i.e. last subject last visit), following any additional parts in the study (eg, LTFU), as applicable. Based on the definition above, the EOS date is the date when the last subject in the trial has completed his/her EOS visit.
    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 months8
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 No
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 162
    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)
    N/A
    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 Decision2019-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-03
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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