Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

January 25, 2024

Study Completion Date

January 9, 2025

Conditions
Chemotherapy-induced Thrombocytopenia
Interventions
BIOLOGICAL

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.

OTHER

Placebo

Placebo Comparator

Trial Locations (117)

1090

Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna

1097

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest

1330

Medical Center Nadezhda Clinical EOOD, Sofia

1756

Specialized Hospital for Active Treatment of Oncology EAD, Sofia

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4400

Centro de Diagnostico Investigacion y Tratamiento, Salta

Landeskrankenhaus Steyr, Steyr

5003

Instituto Oncologico Cordoba, Córdoba

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar, Szeged

7002

Complex Oncology Center - Ruse EOOD, Rousse

8500

Centro de Investigaciones Clínicas Clínica Viedma, Viedma

9024

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz, Győr

10126

Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette, Torino

11526

General Hospital of Athens Laiko, Athens

11528

Aretaieio Hospital, Athens

Evgenidio Hospital I Agia Trias, Athens

12462

Attikon University Hospital, Athens

14564

General Oncology Hospital of Kifissia Agioi Anargyroi, Athens

15036

Oncosalud, Lima

18016

Hospital Clinico Universitario San Cecilio, Granada

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

20817

American Oncology Partners, PA, Bethesda

21202

Mercy Medical Center, Baltimore

22030

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi, Edirne

23040

Oncotech, La Paz

25198

Hospital Universitario Arnau de Vilanova Lleida, Lleida

26100

Azienda Socio Sanitaria Territoriale di Cremona, Cremona

26504

University Hospital of Patras, Pátrai

28050

Hospital Universitario Madrid Sanchinarro, Madrid

29609

Centre Hospitalier Universitaire de Brest, Brest

32005

Complexo Hospitalario Universitario de Ourense, Ourense

32763

Mid Florida Hematology and Oncology Centers PA, Orange City

33321

Oncology and Hematology Associates of West Broward, PA, Tamarac

33331

Cleveland Clinic Florida, Weston

34093

Istanbul Universitesi Onkoloji Enstitusu, Istanbul

34384

Prof Dr Cemil Tascioglu Sehir Hastanesi, Istanbul

34722

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul

35100

Ege Universitesi Tip Fakultesi, Izmir

35575

Izmir Ekonomi Universitesi Medical Point Hastanesi, Izmir

37007

Hospital Clinico Universitario de Salamanca, Salamanca

39401

Hattiesburg Clinic Hematology/Oncology, Hattiesburg

41380

Kocaeli Universitesi Arastirma ve Uygulama Hastanesi, Kocaeli

43204

Hospital Universitari Sant Joan de Reus, Reus

55200

VM Medical Park Samsun Hastanesi, Samsun

55236

Agios Loukas Clinic, Thessaloniki

58013

Communal Institution Chernivtsi Regional Clinical Oncological Dispensary, Chernivtsi

60076

Orchard Healthcare Research Inc, Skokie

65807

Oncology Hematology Associates, Springfield

68000

Oaxaca Site Management Organization SC, Oaxaca City

70112

University Medical Center New Orleans, New Orleans

71105

Christus Highland Cancer Treatment Center, Shreveport

71301

Christus Saint Frances Cabrini Hospital, Alexandria

72401

Saint Bernards Medical Center, Jonesboro

75015

Hôpital Européen Georges Pompidou, Paris

76018

Prykarpatskyy Clinical Oncology Centre, Ivano-Frankivsk

76104

The Center for Cancer and Blood Disorders, Fort Worth

78071

Regional Cancer Care Associates, Sparta

78200

Centro de Atencion e Investigacion Cardiovascular del Potosi Sc, San Luis Potosí City

81505

Colorado West Healthcare System dba Grand Valley Oncology, Grand Junction

88000

Transcarpathian Regional Clinical Oncological Dispensary, Uzhhorod

92150

Hopital Foch, Suresnes

92801

Pacific Cancer Medical Center Inc, Anaheim

92868

University of California Irvine, Orange

94805

Institut Gustave Roussy, Villejuif

98902

Yakima Valley Memorial Hospital, Yakima

99208

Medical Oncology Associates PS, Spokane

125284

Clinical hospital 2, Group of companies medsi, Moscow

143442

Medsi Group, Moscow Region

163045

SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary, Arkhangelsk

191104

Leningrad Regional Oncology Dispensary na L D Roman, Saint Petersburg

197758

FSBI Scientific and Research Oncology Institute named after N N Petrov, Saint Petersburg

200347

Centrul de Oncologie Sf Nectarie SRL, Craiova

230002

Oncomedica Imat, Montería

300239

SC Oncomed SRL, Timișoara

354057

State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region, Sochi

357502

State budget institution of public health Pyatigorsk oncology dispensary, Pyatigorsk

390011

State Institution of Public Health, Ryazan

390013

State Institution of Public Health Tambov Regional Oncology Dispensary, Tambov

400015

Spitalul Clinic al Cailor Ferate Cluj Napoca, Cluj-Napoca

400124

SC Medisprof SRL, Cluj-Napoca

420029

Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan, Kazan'

450054

Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan, Ufa

500152

Policlinica de Diagnostic Rapid, Brasov

603089

LLC Tonus, Nizhny Novgorod

644013

Omsk Regional Clinical Oncology Dispensary, Omsk

700483

Institutul Regional de Oncologie Iasi, Iași

760042

Centro Medico Imbanaco, Santiago de Cali

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07960

Morristown Medical Center, Morristown

C1093AAS

Hospital Universitario Fundacion Favaloro, Ciudad Autonoma de Buenos Aires

80530-010

Instituto de Oncologia do Parana, Curitiba

64049-200

Vencer e Oncoclinica, Teresina

95020-450

Centro de Pesquisa da Serra Gaucha - Cepesg, Caxias do Sul

88301-220

Catarina Pesquisa Clinica, Itajaí

13010-001

Loema Instituto de Pesquisa Clinica e Consultores Ltda, Campinas

08270-120

Casa de Saude Santa Marcelina, São Paulo

B1P 1P3

Cape Breton Cancer Centre, Nova Scotia Health Authority, Sydney

N2G 1G3

Grand River Regional Cancer Centre at Grand River Hospital, Kitchener

050030

Fundacion Colombiana de Cancerologia Clinica Vida, Medellín

06720

Centro Medico Nacional Siglo XXI, México

04001

Hospital Goyeneche, Arequipa

21-500

Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej, Biała Podlaska

95-060

Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o, Brzeziny

60-569

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

60-780

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

1649-035

Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria, Lisbon

4464-513

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano, Matosinhos Municipality

4099-001

Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio, Porto

4200-319

Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao, Porto

5000-508

Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real, Vila Real

022328

Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation, Bucharest

01250

Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi, Adana

06200

Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara

06230

Hacettepe Universitesi Tip Fakultesi, Ankara

06560

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara

06800

Ankara Bilkent Sehir Hastanesi, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY