Spots Global Cancer Trial Database for Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
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Trial Identification
Brief Title: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
Official Title: 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 ID: NCT03937154
Conditions
Study Description
Brief Summary: 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
Detailed Description: This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer. Subjects must have a platelet count ≤ 85 x 10\^9/L on day 1 of the study. The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU). Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
University of Miami School of Medicine, Miami, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Mid Florida Hematology and Oncology Centers PA, Orange City, Florida, United States
Saint Alphonsus Regional Medical Center, Boise, Idaho, 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
Hattiesburg Clinic Hematology/Oncology, Hattiesburg, Mississippi, United States
Oncology Hematology Associates, Springfield, Missouri, United States
Great Falls Clinic, Great Falls, Montana, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Regional Cancer Care Associates, Sparta, New Jersey, United States
Broome Oncology LLC, Binghamton, New York, United States
Saint Lukes University Health Network, Bethlehem, Pennsylvania, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Community Cancer Trials of Utah, Ogden, Utah, United States
Medical Oncology Associates PS, Spokane, Washington, United States
Yakima Valley Memorial Hospital, Yakima, Washington, United States
Instituto Oncologico Cordoba, Ciudad de Cordoba, Córdoba, Argentina
Centro Medico Austral, Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina
Centro de Investigaciones Clínicas Clínica Viedma, Viedma, Río Negro, Argentina
Centro de Diagnostico Investigacion y Tratamiento, Salta, , Argentina
Medizinische Universitaet Innsbruck, Innsbruck, , Austria
Instituto de Oncologia do Parana, Curitba, 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, Sao Paulo, São Paulo, Brazil
Complex Oncology Center - Ruse EOOD, Ruse, , Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Oncology EAD, Sofia, , Bulgaria
James Lind Centro de Investigacion del Cancer, Temuco, Cautín, Chile
Orlandi Oncologia, Santiago, , Chile
Oncomedica Imat, Monteria, Córdoba, Colombia
Centro Medico Imbanaco, Cali, Valle Del Cauca, Colombia
Agios Savvas Anticancer Hospital, Athens, , Greece
Henry Dunant Hospital Center, Athens, , Greece
Sotiria General Hospital, Athens, , Greece
Alexandra Hospital, Athens, , Greece
Attikon University Hospital, Athens, , Greece
University Hospital of Heraklion, Heraklion - Crete, , Greece
Agios Loukas Clinic, Thessaloniki, , Greece
Iatriko Diavalkaniko Thessalonikis, Thessaloniki, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Farkasgyepui Tudogyogyintezet, Farkasgyepu, , Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz, Gyor, , Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz, Szekesfehervar, , Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Reformatus Pulmonologiai Centrum, Torokbalint, , Hungary
Oncotech, La Paz, Baja California Sur, Mexico
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc, San Luis Potosi, San Luis Potosí, Mexico
Centro Medico Nacional Siglo XXI, Mexico, , Mexico
Oaxaca Site Management Organization SC, Oaxaca, , Mexico
Hospital Goyeneche, Arequipa, , Peru
Oncosalud, Lima, , Peru
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o, Brzeziny, , Poland
Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, , Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu, Przemysl, , Poland
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente, Lisboa, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano, Matosinhos, , Portugal
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio, Porto, , Portugal
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao, Porto, , Portugal
Spitalul Universitar de Urgenta Elias, Bucharest, , Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu, Bucharest, , Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu, Bucharest, , Romania
Spitalul Clinic Coltea, Bucharest, , Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj Napoca, , Romania
SC Medisprof SRL, Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Spitalul Municipal Ploiesti, Ploiesti, , Romania
SC Oncomed SRL, Timisoara, , Romania
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary, Arkhangelsk, , Russian Federation
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan, Kazan, , Russian Federation
Medsi Group, Moscow Region, , Russian Federation
State Healthcare Institution Goroda Moskvi City Clinical Hospital 1, Moscow, , Russian Federation
Clinical hospital 2, Group of companies medsi, Moscow, , Russian Federation
LLC Tonus, Nizhniy Novgorod, , Russian Federation
Omsk Regional Clinical Oncology Dispensary, Omsk, , Russian Federation
State budget institution of public health Pyatigorsk oncology dispensary, Pyatigorsk, , Russian Federation
State Institution of Public Health, Ryazan, , Russian Federation
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region, Sochi, , Russian Federation
State Institution of Public Health Tambov Regional Oncology Dispensary, Tambov, , Russian Federation
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan, Ufa, , Russian Federation
Hospital Clinico Universitario San Cecilio, Granada, Andalucía, Spain
Hospital Universitario Nuestra Señora de Valme, Sevilla, Andalucía, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain
Hospital Clinico Universitario de Salamanca, Salamanca, Castilla León, Spain
Instituto Oncologico IOB, Barcelona, Cataluña, Spain
Consorcio Hospitalario Provincial de Castellon, Castellon, Comunidad Valenciana, Spain
Hospital Santa Maria Nai, Ourense, Galicia, Spain
Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho, Ankara, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Ankara Bilkent Sehir Hastanesi, Ankara, , Turkey
Pamukkale Universitesi Tip Fakultesi Hastanesi, Denizli, , Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi, Edirne, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul, , Turkey
Marmara Universitesi Tip Fakultesi Hastanesi, Istanbul, , Turkey
Izmir Ataturk Egitim ve Arastirma Hastanesi, Izmir, , Turkey
Izmir Ekonomi Universitesi Medical Point Hastanesi, Izmir, , Turkey
Kocaeli Universitesi Tip Fakultesi Hastanesi, Kocaeli, , Turkey
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi, Konya, , Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi, Malatya, , Turkey
Namik Kemal Universitesi Hastanesi, Tekirdag, , Turkey
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary, Chernivtsi, , Ukraine
Transcarpathian Regional Clinical Oncological Dispensary, Uzhgorod, , Ukraine
Vinnytsya Regional Clinical Oncological Dispensary, Vinnytsya, , Ukraine
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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