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

NCT03362177 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 201403462017-002992-25
• Study Type: interventional
• Target: 165
• Locations: 20 countries
• Sites: 117

Brief Summary

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

Conditions

Chemotherapy-induced Thrombocytopenia

Keywords

Chemotherapy Induced Thrombocytopenia; Gastrointestinal Cancer; Colorectal Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Had Thrombocytopenia-induced Dose Modification

  Participants met the criteria of the primary endpoint if there was no thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-trial chemotherapy regimen (cycles were up to 3 weeks). A thrombocytopenia-induced modification was defined as any dose reduction, dose delay, dose omission, and/or early chemotherapy treatment discontinuation due to low platelet counts less than 100 x 10\^9/L. The 95% confidence interval (CI) is based on the exact Clopper-Pearson method.

  Day 1 up to Week 12

Secondary Outcomes (9)

• Platelet Count Nadir at the End of the Treatment Period

  Up to 21 weeks

• Kaplan-Meier Estimate of Time to First Platelet Response

  Up to 21 weeks

• Duration-adjusted Event Rate of Bleeding Events in the Treatment Period

  Up to 21 weeks

• Overall Survival

  From Day 1 up to 1 year after last dose of investigational product (IP) (max 1869 days)

• Percentage of Participants Who Had Platelet Transfusions During the Treatment Period

  Up to 21 weeks

Study Arms (2)

Romiplostim

EXPERIMENTAL

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.

Biological: Romiplostim

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Placebo OTHER

Placebo Comparator

Placebo

Romiplostim BIOLOGICAL

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.

Romiplostim

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Previous or Current Medical Conditions
• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (117)

Saint Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Pacific Cancer Medical Center Inc

Anaheim, California, 92801, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Colorado West Healthcare System dba Grand Valley Oncology

Grand Junction, Colorado, 81505, United States

Location

Mid Florida Hematology and Oncology Centers PA

Orange City, Florida, 32763, United States

Location

Oncology and Hematology Associates of West Broward, PA

Tamarac, Florida, 33321, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Orchard Healthcare Research Inc

Skokie, Illinois, 60076, United States

Location

Christus Saint Frances Cabrini Hospital

Alexandria, Louisiana, 71301, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Christus Highland Cancer Treatment Center

Shreveport, Louisiana, 71105, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

American Oncology Partners, PA

Bethesda, Maryland, 20817, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Regional Cancer Care Associates

Sparta, New Jersey, 78071, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Medical Oncology Associates PS

Spokane, Washington, 99208, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Hospital Universitario Fundacion Favaloro

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS, Argentina

Location

Instituto Oncologico Cordoba

Córdoba, Córdoba Province, 5003, Argentina

Location

Centro de Investigaciones Clínicas Clínica Viedma

Viedma, Río Negro Province, 8500, Argentina

Location

Centro de Diagnostico Investigacion y Tratamiento

Salta, 4400, Argentina

Location

Landeskrankenhaus Steyr

Steyr, 4400, Austria

Location

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

Instituto de Oncologia do Parana

Curitiba, Paraná, 80530-010, Brazil

Location

Vencer e Oncoclinica

Teresina, Piauí, 64049-200, Brazil

Location

Centro de Pesquisa da Serra Gaucha - Cepesg

Caxias do Sul, Rio Grande do Sul, 95020-450, Brazil

Location

Catarina Pesquisa Clinica

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Loema Instituto de Pesquisa Clinica e Consultores Ltda

Campinas, São Paulo, 13010-001, Brazil

Location

Casa de Saude Santa Marcelina

São Paulo, São Paulo, 08270-120, Brazil

Location

Complex Oncology Center - Ruse EOOD

Rousse, 7002, Bulgaria

Location

Medical Center Nadezhda Clinical EOOD

Sofia, 1330, Bulgaria

Location

Specialized Hospital for Active Treatment of Oncology EAD

Sofia, 1756, Bulgaria

Location

Cape Breton Cancer Centre, Nova Scotia Health Authority

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Grand River Regional Cancer Centre at Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

Fundacion Colombiana de Cancerologia Clinica Vida

Medellín, Antioquia, 050030, Colombia

Location

Oncomedica Imat

Montería, Departamento de Córdoba, 230002, Colombia

Location

Centro Medico Imbanaco

Cali, Valle del Cauca Department, 760042, Colombia

Location

Centre Hospitalier Universitaire de Brest

Brest, 29609, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

General Hospital of Athens Laiko

Athens, 11526, Greece

Location

Aretaieio Hospital

Athens, 11528, Greece

Location

Evgenidio Hospital I Agia Trias

Athens, 11528, Greece

Location

Attikon University Hospital

Athens, 12462, Greece

Location

General Oncology Hospital of Kifissia Agioi Anargyroi

Athens, 14564, Greece

Location

University Hospital of Patras

Pátrai, 26504, Greece

Location

Agios Loukas Clinic

Thessaloniki, 55236, Greece

Location

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, 1097, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

Győr, 9024, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

Szeged, 6720, Hungary

Location

Azienda Socio Sanitaria Territoriale di Cremona

Cremona, 26100, Italy

Location

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

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

Torino, 10126, Italy

Location

Oncotech

La Paz, Baja California Sur, 23040, Mexico

Location

Centro de Atencion e Investigacion Cardiovascular del Potosi Sc

San Luis Potosí City, San Luis Potosí, 78200, Mexico

Location

Centro Medico Nacional Siglo XXI

México, 06720, Mexico

Location

Oaxaca Site Management Organization SC

Oaxaca City, 68000, Mexico

Location

Hospital Goyeneche

Arequipa, 04001, Peru

Location

Oncosalud

Lima, 15036, Peru

Location

Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

Biała Podlaska, 21-500, Poland

Location

Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

Brzeziny, 95-060, Poland

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569, Poland

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-780, Poland

Location

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

Lisbon, 1649-035, Portugal

Location

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

Matosinhos Municipality, 4464-513, Portugal

Location

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

Porto, 4099-001, Portugal

Location

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

Porto, 4200-319, Portugal

Location

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

Vila Real, 5000-508, Portugal

Location

Policlinica de Diagnostic Rapid

Brasov, 500152, Romania

Location

Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation

Bucharest, 022328, Romania

Location

Spitalul Clinic al Cailor Ferate Cluj Napoca

Cluj-Napoca, 400015, Romania

Location

SC Medisprof SRL

Cluj-Napoca, 400124, Romania

Location

Centrul de Oncologie Sf Nectarie SRL

Craiova, 200347, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

SC Oncomed SRL

Timișoara, 300239, Romania

Location

SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary

Arkhangelsk, 163045, Russia

Location

Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan

Kazan', 420029, Russia

Location

Clinical hospital 2, Group of companies medsi

Moscow, 125284, Russia

Location

Medsi Group

Moscow Region, 143442, Russia

Location

LLC Tonus

Nizhny Novgorod, 603089, Russia

Location

Omsk Regional Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

State budget institution of public health Pyatigorsk oncology dispensary

Pyatigorsk, 357502, Russia

Location

State Institution of Public Health

Ryazan, 390011, Russia

Location

Leningrad Regional Oncology Dispensary na L D Roman

Saint Petersburg, 191104, Russia

Location

FSBI Scientific and Research Oncology Institute named after N N Petrov

Saint Petersburg, 197758, Russia

Location

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

Sochi, 354057, Russia

Location

State Institution of Public Health Tambov Regional Oncology Dispensary

Tambov, 390013, Russia

Location

Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan

Ufa, 450054, Russia

Location

Hospital Clinico Universitario San Cecilio

Granada, Andalusia, 18016, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Universitario Arnau de Vilanova Lleida

Lleida, Catalonia, 25198, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, Catalonia, 43204, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, Galicia, 32005, Spain

Location

Hospital Universitario Madrid Sanchinarro

Madrid, 28050, Spain

Location

Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

Adana, 01250, Turkey (Türkiye)

Location

Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, 06200, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi

Ankara, 06230, Turkey (Türkiye)

Location

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul Universitesi Onkoloji Enstitusu

Istanbul, 34093, Turkey (Türkiye)

Location

Prof Dr Cemil Tascioglu Sehir Hastanesi

Istanbul, 34384, Turkey (Türkiye)

Location

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi

Izmir, 35100, Turkey (Türkiye)

Location

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, 35575, Turkey (Türkiye)

Location

Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

Kocaeli, 41380, Turkey (Türkiye)

Location

VM Medical Park Samsun Hastanesi

Samsun, 55200, Turkey (Türkiye)

Location

Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

Chernivtsi, 58013, Ukraine

Location

Prykarpatskyy Clinical Oncology Centre

Ivano-Frankivsk, 76018, Ukraine

Location

Transcarpathian Regional Clinical Oncological Dispensary

Uzhhorod, 88000, Ukraine

Location

Related Publications (1)

• Al-Samkari H, Munoz C, Geredeli C, Korantzis I, Gonzalez Astorga B, Arslan C, Cordeiro Camargo JF, Scotte F, Borges G, Wang K, Eisen M, Kuter DJ, Soff GA. Romiplostim versus Placebo for Chemotherapy-Induced Thrombocytopenia. N Engl J Med. 2026 Mar 12;394(11):1061-1073. doi: 10.1056/NEJMoa2511882.

  PMID: 41812193 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: December 5, 2017
• Study Start: September 30, 2019
• Primary Completion: January 25, 2024
• Study Completion: January 9, 2025
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

FR (4); PT (5); UA (3); HU (4); PL (4); ES (6); TU (13); US (22); AR (4); CO (3); IT (3); AU (2); RO (7); GR (7); RU (13); BR (6); ME (4); PE (2); BU (3); CA (2)