Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
NCT ID: NCT03362177
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2019-09-30
2025-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Romiplostim
Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
Romiplostim
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.
Placebo
Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
Placebo
Placebo Comparator
Interventions
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Romiplostim
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.
Placebo
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
* Males or females greater than or equal to 18 years of age at signing of the informed consent.
* Histologically or cytologically confirmed diagnosis of gastrointestinal, pancreatic, or colorectal adenocarcinoma, defined as cancers of the esophagus (including esophagogastric junction \[EGJ\] cancer), stomach, pancreas, colon, or rectum. Tumor stage will not affect eligibility.
* Subjects must be receiving 1 of the following regimens: An oxaliplatin-based chemotherapy regimen, containing 5 FU or capecitabine plus oxaliplatin (irinotecan may be added for FOLFIRINOX or FOLFOXIRI) on a 14- or 21 day schedule, respectively; OR, subjects must have chemotherapy-induced thrombocytopenia from a non-protocol chemotherapy regimen, planning to start treatment with one of the protocol chemotherapy regimens which has been delayed greater than or equal to one week due to chemotherapy-induced thrombocytopenia. Note: Use of these regimens are permitted with (1) anti angiogenic agents (such as bevacizumab) or (2) targeted therapy (such as anti epidermal growth factor receptor agents);
* Subjects must have a local platelet count ≤ 85 x 10\^9/L on study day 1.
* Subjects must be at least 14 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if they received FOLFOX, FOLFIRINOX or FOLFOXIRI, and 21 days removed if they received CAPEOX.
* Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion Criteria
* Acute lymphoblastic leukemia.
* Acute myeloid leukemia.
* Any myeloid malignancy.
* Myelodysplastic 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.
* Myeloproliferative disease.
* Multiple myeloma.
* Within 4 months prior to enrollment, 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.
* Major surgery ≤ 28 days or minor surgery ≤ 3 days prior to enrollment.
* New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be both stable and suitable for continued therapeutic anticoagulation during trial participation.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months of screening.
* Evidence of active infection within 2 weeks prior to first dose of study treatment.
* Known human immunodeficiency virus infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available, use central laboratory results.
* Known active chronic hepatitis B or C infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available, use central laboratory results. Hepatitis B and C infection is based on the following results:
* Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
* Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
* Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
* Secondary malignancy within the past 5 years except:
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated cervical carcinoma in situ without evidence of disease.
* Adequately treated breast ductal carcinoma in situ without evidence of disease.
* Prostatic intraepithelial neoplasia without evidence of prostate cancer.
* Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
* Malignancy treated with curative intent and with no known active disease present for at least 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
* Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).
Prior/Concomitant Therapy
• Previous 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.
Prior/Concurrent Clinical Study Experience • Currently 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 investigational procedures while participating in this study are excluded.
Diagnostic Assessments
* Anemia (hemoglobin \<80 g/L \[8 g/dL\]) on the day of initiation of investigational product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines.
* Neutropenia (absolute neutrophil count 1 x 10\^9/L) on the day of initiation of investigational product as assessed by local labs. Use of granulocyte-colony stimulating factor is permitted throughout the study as per institutional guidelines.
* Abnormal renal function with creatinine clearance \< 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory during screening. If local laboratory results are not available, use central laboratory results.
* Abnormal liver function (total bilirubin \> 3 X ULN; alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 X ULN for subjects without liver metastases or ≥ 5 X ULN for subjects with liver metastases) as assessed by local laboratory during screening. If local laboratory results are not available, use central laboratory results.
Other Exclusions
* Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after treatment (and chemotherapy) discontinuation (females of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)
* Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 6 months after treatment (and chemotherapy) discontinuation.
* Males 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 additional 6 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.
* Subject has known sensitivity to any of the products to be administered during dosing.
* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, COAs) to the best of the subject and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for an additional period of 6 months after treatment (and chemotherapy) discontinuation.
* Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 6 months after treatment (and chemotherapy) discontinuation.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Saint Bernards Medical Center
Jonesboro, Arkansas, United States
Pacific Cancer Medical Center Inc
Anaheim, California, United States
University of California Irvine
Orange, California, United States
Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction, Colorado, United States
Mid Florida Hematology and Oncology Centers PA
Orange City, Florida, United States
Oncology and Hematology Associates of West Broward, PA
Tamarac, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Orchard Healthcare Research Inc
Skokie, Illinois, United States
Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
American Oncology Partners, PA
Bethesda, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Regional Cancer Care Associates
Sparta, New Jersey, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Medical Oncology Associates PS
Spokane, Washington, United States
Yakima Valley Memorial Hospital
Yakima, Washington, United States
Hospital Universitario Fundacion Favaloro
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Oncologico Cordoba
Córdoba, Córdoba Province, Argentina
Centro de Investigaciones Clínicas Clínica Viedma
Viedma, Río Negro Province, Argentina
Centro de Diagnostico Investigacion y Tratamiento
Salta, , Argentina
Landeskrankenhaus Steyr
Steyr, , Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, , Austria
Instituto de Oncologia do Parana
Curitiba, Paraná, Brazil
Vencer e Oncoclinica
Teresina, Piauí, Brazil
Centro de Pesquisa da Serra Gaucha - Cepesg
Caxias do Sul, Rio Grande do Sul, Brazil
Catarina Pesquisa Clinica
Itajaí, Santa Catarina, Brazil
Loema Instituto de Pesquisa Clinica e Consultores Ltda
Campinas, São Paulo, Brazil
Casa de Saude Santa Marcelina
São Paulo, São Paulo, Brazil
Complex Oncology Center - Ruse EOOD
Rousse, , Bulgaria
Medical Center Nadezhda Clinical EOOD
Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Oncology EAD
Sofia, , Bulgaria
Cape Breton Cancer Centre, Nova Scotia Health Authority
Sydney, Nova Scotia, Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, Ontario, Canada
Fundacion Colombiana de Cancerologia Clinica Vida
Medellín, Antioquia, Colombia
Oncomedica Imat
Montería, Departamento de Córdoba, Colombia
Centro Medico Imbanaco
Cali, Valle del Cauca Department, Colombia
Centre Hospitalier Universitaire de Brest
Brest, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hopital Foch
Suresnes, , France
Institut Gustave Roussy
Villejuif, , France
General Hospital of Athens Laiko
Athens, , Greece
Aretaieio Hospital
Athens, , Greece
Evgenidio Hospital I Agia Trias
Athens, , Greece
Attikon University Hospital
Athens, , Greece
General Oncology Hospital of Kifissia Agioi Anargyroi
Athens, , Greece
University Hospital of Patras
Pátrai, , Greece
Agios Loukas Clinic
Thessaloniki, , Greece
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, , Hungary
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette
Torino, , Italy
Oncotech
La Paz, Baja California Sur, Mexico
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
San Luis Potosí City, San Luis Potosí, Mexico
Centro Medico Nacional Siglo XXI
México, , Mexico
Oaxaca Site Management Organization SC
Oaxaca City, , Mexico
Hospital Goyeneche
Arequipa, , Peru
Oncosalud
Lima, , Peru
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska, , Poland
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
Brzeziny, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
Porto, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
Porto, , Portugal
Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real
Vila Real, , Portugal
Policlinica de Diagnostic Rapid
Brasov, , Romania
Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation
Bucharest, , Romania
Spitalul Clinic al Cailor Ferate Cluj Napoca
Cluj-Napoca, , Romania
SC Medisprof SRL
Cluj-Napoca, , Romania
Centrul de Oncologie Sf Nectarie SRL
Craiova, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
SC Oncomed SRL
Timișoara, , Romania
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
Arkhangelsk, , Russia
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
Kazan', , Russia
Clinical hospital 2, Group of companies medsi
Moscow, , Russia
Medsi Group
Moscow Region, , Russia
LLC Tonus
Nizhny Novgorod, , Russia
Omsk Regional Clinical Oncology Dispensary
Omsk, , Russia
State budget institution of public health Pyatigorsk oncology dispensary
Pyatigorsk, , Russia
State Institution of Public Health
Ryazan, , Russia
Leningrad Regional Oncology Dispensary na L D Roman
Saint Petersburg, , Russia
FSBI Scientific and Research Oncology Institute named after N N Petrov
Saint Petersburg, , Russia
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
Sochi, , Russia
State Institution of Public Health Tambov Regional Oncology Dispensary
Tambov, , Russia
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
Ufa, , Russia
Hospital Clinico Universitario San Cecilio
Granada, Andalusia, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital Universitario Arnau de Vilanova Lleida
Lleida, Catalonia, Spain
Hospital Universitari Sant Joan de Reus
Reus, Catalonia, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
Adana, , Turkey (Türkiye)
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, , Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu
Istanbul, , Turkey (Türkiye)
Prof Dr Cemil Tascioglu Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, , Turkey (Türkiye)
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
Kocaeli, , Turkey (Türkiye)
VM Medical Park Samsun Hastanesi
Samsun, , Turkey (Türkiye)
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
Chernivtsi, , Ukraine
Prykarpatskyy Clinical Oncology Centre
Ivano-Frankivsk, , Ukraine
Transcarpathian Regional Clinical Oncological Dispensary
Uzhhorod, , Ukraine
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2017-002992-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20140346
Identifier Type: -
Identifier Source: org_study_id
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