- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937154
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Amgen Call Center
- Phone Number: 866-572-6436
- Email: medinfo@amgen.com
Study Locations
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Salta, Argentina, 4400
- Recruiting
- Centro de Diagnostico Investigacion y Tratamiento
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Córdoba
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Ciudad de Cordoba, Córdoba, Argentina, X5002HWE
- Recruiting
- Instituto Oncologico Cordoba
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Distrito Federal
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Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1019ABS
- Recruiting
- Centro Medico Austral
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Río Negro
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Viedma, Río Negro, Argentina, 8500
- Recruiting
- Centro de Investigaciones Clínicas Clínica Viedma
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Innsbruck, Austria, 6020
- Terminated
- Medizinische Universitaet Innsbruck
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Paraná
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Curitba, Paraná, Brazil, 81520-060
- Recruiting
- Instituto de Oncologia do Parana
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Piauí
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Teresina, Piauí, Brazil, 64049-200
- Recruiting
- Vencer e Oncoclinica
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Rio Grande Do Sul
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Caxias do Sul, Rio Grande Do Sul, Brazil, 95020-450
- Terminated
- Centro de Pesquisa da Serra Gaucha - Cepesg
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Santa Catarina
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Itajaí, Santa Catarina, Brazil, 88301-220
- Recruiting
- Catarina Pesquisa Clinica
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São Paulo
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Campinas, São Paulo, Brazil, 13010-001
- Terminated
- Loema Instituto de Pesquisa Clinica e Consultores Ltda
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Sao Paulo, São Paulo, Brazil, 08270-120
- Recruiting
- Casa de Saude Santa Marcelina
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Ruse, Bulgaria, 7002
- Terminated
- Complex Oncology Center - Ruse EOOD
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Sofia, Bulgaria, 1632
- Terminated
- Multiprofile Hospital for Active Treatment Serdika EOOD
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Sofia, Bulgaria, 1756
- Terminated
- Specialized Hospital for Active Treatment of Oncology EAD
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Santiago, Chile, 7500713
- Terminated
- Orlandi Oncologia
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Cautín
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Temuco, Cautín, Chile, 4800827
- Terminated
- James Lind Centro de Investigacion del Cancer
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Córdoba
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Monteria, Córdoba, Colombia, 230002
- Terminated
- Oncomedica Imat
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760042
- Terminated
- Centro Medico Imbanaco
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Athens, Greece, 11526
- Recruiting
- Henry Dunant Hospital Center
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Athens, Greece, 11528
- Recruiting
- Alexandra Hospital
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Athens, Greece, 11522
- Recruiting
- Agios Savvas Anticancer Hospital
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Athens, Greece, 11527
- Terminated
- Sotiria General Hospital
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Athens, Greece, 12462
- Terminated
- Attikon University Hospital
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Heraklion - Crete, Greece, 71500
- Recruiting
- University Hospital of Heraklion
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Thessaloniki, Greece, 55236
- Recruiting
- Agios Loukas Clinic
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Thessaloniki, Greece, 57001
- Recruiting
- Iatriko Diavalkaniko Thessalonikis
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-
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Budapest, Hungary, 1083
- Terminated
- Semmelweis Egyetem
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Farkasgyepu, Hungary, 8582
- Terminated
- Farkasgyepui Tudogyogyintezet
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Gyor, Hungary, 9024
- Terminated
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
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Szekesfehervar, Hungary, 8000
- Terminated
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
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Szolnok, Hungary, 5004
- Terminated
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
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Torokbalint, Hungary, 2045
- Terminated
- Torokbalinti Tudogyogyintezet
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-
-
-
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Mexico, Mexico, 06720
- Recruiting
- Centro Medico Nacional Siglo XXI
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Oaxaca, Mexico, 68000
- Recruiting
- Oaxaca Site Management Organization SC
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Baja California Sur
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La Paz, Baja California Sur, Mexico, 23040
- Recruiting
- Oncotech
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San Luis Potosí
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San Luis Potosi, San Luis Potosí, Mexico, 78200
- Recruiting
- Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
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-
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Arequipa, Peru, 04001
- Recruiting
- Hospital Goyeneche
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Lima, Peru, 15036
- Recruiting
- Oncosalud
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-
-
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Brzeziny, Poland, 95-060
- Terminated
- Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
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Poznan, Poland, 60-569
- Recruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Przemysl, Poland, 37-700
- Recruiting
- Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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-
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Lisboa, Portugal, 1769-001
- Recruiting
- Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
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Matosinhos, Portugal, 4464-513
- Recruiting
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
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Porto, Portugal, 4099-001
- Terminated
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
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Porto, Portugal, 4200-319
- Terminated
- Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
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-
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Bucharest, Romania, 022338
- Recruiting
- Institutul Oncologic, Prof Dr Alexandru Trestioreanu
-
Bucharest, Romania, 030171
- Recruiting
- Spitalul Clinic Coltea
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Bucharest, Romania, 011461
- Recruiting
- Spitalul Universitar de Urgenta Elias
-
Bucharest, Romania, 022328
- Completed
- Institutul Oncologic, Prof Dr Alexandru Trestioreanu
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Cluj Napoca, Romania, 400015
- Recruiting
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
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Iasi, Romania, 700483
- Completed
- Institutul Regional de Oncologie Iasi
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Ploiesti, Romania, 100337
- Recruiting
- Spitalul Municipal Ploiesti
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Timisoara, Romania, 300239
- Recruiting
- SC Oncomed SRL
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-
-
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Arkhangelsk, Russian Federation, 163045
- Recruiting
- SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
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Kazan, Russian Federation, 420029
- Recruiting
- Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
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Moscow, Russian Federation, 119049
- Terminated
- State Healthcare Institution Goroda Moskvi City Clinical Hospital 1
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Moscow, Russian Federation, 125284
- Recruiting
- Clinical hospital 2, Group of companies medsi
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Moscow Region, Russian Federation, 143442
- Recruiting
- Medsi Group
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Nizhniy Novgorod, Russian Federation, 603089
- Completed
- LLC Tonus
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Omsk, Russian Federation, 644013
- Recruiting
- Omsk Regional Clinical Oncology Dispensary
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Pyatigorsk, Russian Federation, 357502
- Terminated
- State budget institution of public health Pyatigorsk oncology dispensary
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Ryazan, Russian Federation, 390011
- Terminated
- State Institution of Public Health
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Sochi, Russian Federation, 354057
- Terminated
- State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
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Tambov, Russian Federation, 390013
- Terminated
- State Institution of Public Health Tambov Regional Oncology Dispensary
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Ufa, Russian Federation, 450054
- Recruiting
- Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
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-
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-
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Madrid, Spain, 28050
- Recruiting
- Hospital Universitario Madrid Sanchinarro
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Andalucía
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Granada, Andalucía, Spain, 18016
- Recruiting
- Hospital Clinico Universitario San Cecilio
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Sevilla, Andalucía, Spain, 41013
- Recruiting
- Hospital Universitario Virgen Del Rocio
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Sevilla, Andalucía, Spain, 41013
- Recruiting
- Hospital Universitario Nuestra Señora de Valme
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Castilla León
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Salamanca, Castilla León, Spain, 37007
- Terminated
- Hospital Clinico Universitario de Salamanca
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Cataluña
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Barcelona, Cataluña, Spain, 08023
- Recruiting
- Instituto Oncologico IOB
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Comunidad Valenciana
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Castellon, Comunidad Valenciana, Spain, 12002
- Recruiting
- Consorcio Hospitalario Provincial de Castellon
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Galicia
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Ourense, Galicia, Spain, 32005
- Terminated
- Hospital Santa Maria Nai
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Madrid
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Fuenlabrada, Madrid, Spain, 28942
- Recruiting
- Hospital Universitario de Fuenlabrada
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-
-
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Ankara, Turkey, 06520
- Recruiting
- Memorial Ankara Hastanesi
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Ankara, Turkey, 06010
- Recruiting
- Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
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Ankara, Turkey, 06200
- Terminated
- Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
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Ankara, Turkey, 06280
- Completed
- Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho
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Ankara, Turkey, 06200
- Recruiting
- Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
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Ankara, Turkey, 06800
- Recruiting
- Ankara Bilkent Sehir Hastanesi
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Denizli, Turkey, 20070
- Recruiting
- Pamukkale Universitesi Tip Fakultesi Hastanesi
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Edirne, Turkey, 22030
- Terminated
- Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
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Istanbul, Turkey, 34098
- Terminated
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
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Istanbul, Turkey, 34890
- Recruiting
- Marmara Universitesi Tip Fakultesi Hastanesi
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Izmir, Turkey, 35150
- Recruiting
- Izmir Ataturk Egitim ve Arastirma Hastanesi
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Izmir, Turkey, 35575
- Recruiting
- Izmir Ekonomi Universitesi Medical Point Hastanesi
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Kocaeli, Turkey, 41380
- Recruiting
- Kocaeli Universitesi Tip Fakultesi Hastanesi
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Konya, Turkey, 42090
- Recruiting
- Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
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Malatya, Turkey, 44280
- Recruiting
- Inonu Universitesi Turgut Ozal Tip Merkezi
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Tekirdag, Turkey, 59100
- Recruiting
- Namik Kemal Universitesi Hastanesi
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-
-
-
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Chernivtsi, Ukraine, 58013
- Recruiting
- Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
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Uzhgorod, Ukraine, 88011
- Recruiting
- Transcarpathian Regional Clinical Oncological Dispensary
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Vinnytsya, Ukraine, 21029
- Recruiting
- Vinnytsya Regional Clinical Oncological Dispensary
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-
-
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Arkansas
-
Jonesboro, Arkansas, United States, 72401
- Recruiting
- Saint Bernards Medical Center
-
-
California
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Anaheim, California, United States, 92801
- Completed
- Pacific Cancer Medical Center Inc
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Orange, California, United States, 92868
- Completed
- University of California Irvine
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Colorado
-
Grand Junction, Colorado, United States, 81505
- Terminated
- Colorado West Healthcare System dba Grand Valley Oncology
-
-
Florida
-
Ocala, Florida, United States, 34474
- Completed
- Ocala Oncology Center
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Orange City, Florida, United States, 32763
- Recruiting
- Mid Florida Hematology and Oncology Centers PA
-
-
Idaho
-
Boise, Idaho, United States, 83706
- Recruiting
- Saint Alphonsus Regional Medical Center
-
-
Illinois
-
Skokie, Illinois, United States, 60076
- Recruiting
- Orchard Healthcare Research Inc
-
-
Louisiana
-
Alexandria, Louisiana, United States, 71301
- Terminated
- Christus Saint Frances Cabrini Hospital
-
New Orleans, Louisiana, United States, 70112
- Terminated
- University Medical Center New Orleans
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Shreveport, Louisiana, United States, 71105
- Recruiting
- Christus Highland Cancer Treatment Center
-
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Maryland
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Baltimore, Maryland, United States, 21202
- Terminated
- Mercy Medical Center
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Bethesda, Maryland, United States, 20817
- Recruiting
- American Oncology Partners, PA
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital Cancer Center
-
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Mississippi
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Hattiesburg, Mississippi, United States, 39401
- Terminated
- Hattiesburg Clinic Hematology/Oncology
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Missouri
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Springfield, Missouri, United States, 65807
- Completed
- Oncology Hematology Associates
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Montana
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Great Falls, Montana, United States, 59405
- Recruiting
- Great Falls Clinic
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Nebraska
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Omaha, Nebraska, United States, 68130
- Recruiting
- Nebraska Cancer Specialists
-
-
New Jersey
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Sparta, New Jersey, United States, 78071
- Terminated
- Regional Cancer Care Associates
-
-
New York
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Binghamton, New York, United States, 13905
- Terminated
- Broome Oncology LLC
-
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Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18015
- Completed
- Saint Lukes University Health Network
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Texas
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Fort Worth, Texas, United States, 76104
- Completed
- The Center for Cancer and Blood Disorders
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Utah
-
Ogden, Utah, United States, 84403
- Recruiting
- Community Cancer Trials of Utah
-
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Washington
-
Spokane, Washington, United States, 99208
- Recruiting
- Medical Oncology Associates PS
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Yakima, Washington, United States, 98902
- Recruiting
- Yakima Valley Memorial Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Males or females greater than or equal to 18 years of age at signing of the informed consent.
- 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.
- 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 carboplatinum-based 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.
- Subjects must have a local platelet count ≤ 85 x 109/L on day 1 of the study.
- 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.
- 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 greater than 470 msec, pericardial disease, or myocardial infarction.
- Major surgery less than or equal to 28 days or minor surgery less than or equal to 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 stable and suitable for continued therapeutic anticoagulation during trial participation.
- History of arterial thrombotic events (eg, myocardial ischemia, transient ischemic attack, or stroke) within 6 months prior to screening.
- Evidence of active infection within 2 weeks prior to the first dose of study treatment.
- Known human immunodeficiency virus infection with any detectable viral load at screening. 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 of chronic hepatitis C or hepatitis B 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: hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
- In addition to the conditions listed in exclusion criteria 201 through 206, 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 greater than or equal to 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding malignancies listed in exclusion criteria 201 - 206).
- Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).
- Any combined modality regimen containing radiation therapy or surgery occurring concomitantly with neo-adjuvant chemotherapy or where radiation therapy is planned during the cycle preceding 3 planned on-study cycles of chemotherapy.
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 (or plan to receive) 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 less than 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 less than 30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by local laboratory. If local laboratory results are not available use central laboratory results.
during screening.
- Abnormal liver function (total bilirubin greater than 3X ULN; alanine aminotransferase [ALT] or aspartate aminotransferase [AST] greater than 3X ULN for subjects without liver metastases or greater than or equal to 5X 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 7 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 7 months after treatment (and chemotherapy) discontinuation. Refer to Appendix 5 for additional contraceptive information.
- 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 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.
- 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 7 months after treatment (and chemotherapy) discontinuation.
- Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Romiplostim
The study in a 2:1 randomization ratio(108 subjects to romiplostim).
Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
|
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer
Other Names:
|
Placebo Comparator: Placebo
The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
|
Placebo comparator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of either a chemotherapy dose delay or reduction
Time Frame: 48 days
|
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
|
48 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depth of Platelet Count
Time Frame: 48 days
|
the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
|
48 days
|
Time to First platelet response
Time Frame: 7 days
|
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
|
7 days
|
the duration-adjusted event rate of ≥ grade 2 bleeding events
Time Frame: 48 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
|
48 days
|
Overall survival
Time Frame: 1 Year
|
1-year overall survival
|
1 Year
|
Proportion of subjects with at leat 1 incidence of platelet transfusion
Time Frame: 48 days
|
platelet transfusion(s) during the treatment period
|
48 days
|
proportion of patients achieving platelet count >= 100 x 10 9/L
Time Frame: 7 days
|
7 days after 3rd dose of IP with no transfusions in preceding 7 days
|
7 days
|
The subject incidence of adverse events
Time Frame: 36 months
|
Through end of study, up to 36 months.
It will be counted in as an adverse event: any treatment - emergent adverse events, fatal adverse events, serious adverse events, or clinically significant changes in laboratory values.
|
36 months
|
Number of subjects who develop anti-romiplostim antibodies
Time Frame: 36 Months
|
Through end of study up to 36 months
|
36 Months
|
Number of subjects who develop anti-TPO antibodies
Time Frame: 36 months
|
Through end of study, up to 36 months
|
36 months
|
Number of subjects who experience myelodysplastic syndromes
Time Frame: 36 months
|
Through end of study, up to 36 months
|
36 months
|
Number of subjects who experience secondary malignancies
Time Frame: 36 months
|
Through end of study, up to 36 months
|
36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Hematologic Diseases
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Blood Platelet Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Cytopenia
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Thrombocytopenia
Other Study ID Numbers
- 20170770
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemotherapy-induced Thrombocytopenia
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Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingChemotherapy-Induced Thrombocytopenia
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Sobi, Inc.CompletedChemotherapy-induced ThrombocytopeniaUnited States, China, Hungary, Poland, Russian Federation, Serbia, Ukraine
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Beijing Northland Biotech. Co., Ltd.CompletedChemotherapy-induced ThrombocytopeniaChina
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BioMAS LtdTerminatedChemotherapy Induced ThrombocytopeniaIsrael
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Qilu Pharmaceutical Co., Ltd.RecruitingChemotherapy-induced ThrombocytopeniaChina
-
Qilu Pharmaceutical Co., Ltd.CompletedChemotherapy-induced ThrombocytopeniaChina
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Napolitano MariasantaRegione SiciliaTerminatedThrombocytopenia | Primary Thrombocytopenia,Unspecified | Thrombocytopenia Chemotherapy InducedItaly
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Jiangsu HengRui Medicine Co., Ltd.Withdrawn
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruitingChemotherapy-Induced ThrombocytopeniaChina
-
Ono Pharma USA IncTerminatedChemotherapy-Induced ThrombocytopeniaUnited States, Korea, Republic of, Russian Federation
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States