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New hope for cancer patients: drug may prevent Chemo-Induced bleeding risk

NCT ID NCT03362177

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called romiplostim in 165 adults with gastrointestinal, pancreatic, or colorectal cancer who were receiving chemotherapy. The goal was to see if romiplostim could prevent low platelet counts (thrombocytopenia) that often force doctors to delay or reduce chemotherapy doses. The drug aims to help patients complete their planned chemo cycles without interruptions due to low platelets.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

165 people

The number who actually took part.

Started

Sep 2019

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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: 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). * 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.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity colorectal adenocarcinoma colorectal neoplasm digestive system neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy-induced thrombocytopenia

Contacts and locations

Locations

  • Agios Loukas Clinic

    Thessaloniki, 55236, Greece

  • American Oncology Partners, PA

    Bethesda, Maryland, 20817, United States

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800, Turkey (Türkiye)

  • Aretaieio Hospital

    Athens, 11528, Greece

  • Attikon University Hospital

    Athens, 12462, Greece

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

    Kazan', 420029, Russia

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

    Torino, 10126, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, 26100, Italy

  • Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01250, Turkey (Türkiye)

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cape Breton Cancer Centre, Nova Scotia Health Authority

    Sydney, Nova Scotia, B1P 1P3, Canada

  • Casa de Saude Santa Marcelina

    São Paulo, São Paulo, 08270-120, Brazil

  • Catarina Pesquisa Clinica

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Centre Hospitalier Universitaire de Brest

    Brest, 29609, France

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

    Vila Real, 5000-508, Portugal

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

    Lisbon, 1649-035, Portugal

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

    Porto, 4200-319, Portugal

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

    Porto, 4099-001, Portugal

  • Centro Medico Imbanaco

    Cali, Valle del Cauca Department, 760042, Colombia

  • Centro Medico Nacional Siglo XXI

    México, 06720, Mexico

  • Centro de Atencion e Investigacion Cardiovascular del Potosi Sc

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

  • Centro de Diagnostico Investigacion y Tratamiento

    Salta, 4400, Argentina

  • Centro de Investigaciones Clínicas Clínica Viedma

    Viedma, Río Negro Province, 8500, Argentina

  • Centro de Pesquisa da Serra Gaucha - Cepesg

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

  • Centrul de Oncologie Sf Nectarie SRL

    Craiova, 200347, Romania

  • Christus Highland Cancer Treatment Center

    Shreveport, Louisiana, 71105, United States

  • Christus Saint Frances Cabrini Hospital

    Alexandria, Louisiana, 71301, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Clinical hospital 2, Group of companies medsi

    Moscow, 125284, Russia

  • Colorado West Healthcare System dba Grand Valley Oncology

    Grand Junction, Colorado, 81505, United States

  • Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

    Chernivtsi, 58013, Ukraine

  • Complex Oncology Center - Ruse EOOD

    Rousse, 7002, Bulgaria

  • Complexo Hospitalario Universitario de Ourense

    Ourense, Galicia, 32005, Spain

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097, Hungary

  • Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200, Turkey (Türkiye)

  • Ege Universitesi Tip Fakultesi

    Izmir, 35100, Turkey (Türkiye)

  • Evgenidio Hospital I Agia Trias

    Athens, 11528, Greece

  • FSBI Scientific and Research Oncology Institute named after N N Petrov

    Saint Petersburg, 197758, Russia

  • Fundacion Colombiana de Cancerologia Clinica Vida

    Medellín, Antioquia, 050030, Colombia

  • Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation

    Bucharest, 022328, Romania

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560, Turkey (Türkiye)

  • General Hospital of Athens Laiko

    Athens, 11526, Greece

  • General Oncology Hospital of Kifissia Agioi Anargyroi

    Athens, 14564, Greece

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722, Turkey (Türkiye)

  • Grand River Regional Cancer Centre at Grand River Hospital

    Kitchener, Ontario, N2G 1G3, Canada

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

    Győr, 9024, Hungary

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230, Turkey (Türkiye)

  • Hattiesburg Clinic Hematology/Oncology

    Hattiesburg, Mississippi, 39401, United States

  • Hopital Foch

    Suresnes, 92150, France

  • Hospital Clinico Universitario San Cecilio

    Granada, Andalusia, 18016, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Castille and León, 37007, Spain

  • Hospital Goyeneche

    Arequipa, 04001, Peru

  • Hospital Universitari Sant Joan de Reus

    Reus, Catalonia, 43204, Spain

  • Hospital Universitario Arnau de Vilanova Lleida

    Lleida, Catalonia, 25198, Spain

  • Hospital Universitario Fundacion Favaloro

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

  • Hospital Universitario Madrid Sanchinarro

    Madrid, 28050, Spain

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Oncologico Cordoba

    Córdoba, Córdoba Province, 5003, Argentina

  • Instituto de Oncologia do Parana

    Curitiba, Paraná, 80530-010, Brazil

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Istanbul Universitesi Onkoloji Enstitusu

    Istanbul, 34093, Turkey (Türkiye)

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575, Turkey (Türkiye)

  • Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

    Kocaeli, 41380, Turkey (Türkiye)

  • LLC Tonus

    Nizhny Novgorod, 603089, Russia

  • Landeskrankenhaus Steyr

    Steyr, 4400, Austria

  • Leningrad Regional Oncology Dispensary na L D Roman

    Saint Petersburg, 191104, Russia

  • Loema Instituto de Pesquisa Clinica e Consultores Ltda

    Campinas, São Paulo, 13010-001, Brazil

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Medical Center Nadezhda Clinical EOOD

    Sofia, 1330, Bulgaria

  • Medical Oncology Associates PS

    Spokane, Washington, 99208, United States

  • Medsi Group

    Moscow Region, 143442, Russia

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Mid Florida Hematology and Oncology Centers PA

    Orange City, Florida, 32763, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Oaxaca Site Management Organization SC

    Oaxaca City, 68000, Mexico

  • Omsk Regional Clinical Oncology Dispensary

    Omsk, 644013, Russia

  • Oncology Hematology Associates

    Springfield, Missouri, 65807, United States

  • Oncology and Hematology Associates of West Broward, PA

    Tamarac, Florida, 33321, United States

  • Oncomedica Imat

    Montería, Departamento de Córdoba, 230002, Colombia

  • Oncosalud

    Lima, 15036, Peru

  • Oncotech

    La Paz, Baja California Sur, 23040, Mexico

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60076, United States

  • Pacific Cancer Medical Center Inc

    Anaheim, California, 92801, United States

  • Policlinica de Diagnostic Rapid

    Brasov, 500152, Romania

  • Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

    Brzeziny, 95-060, Poland

  • Prof Dr Cemil Tascioglu Sehir Hastanesi

    Istanbul, 34384, Turkey (Türkiye)

  • Prykarpatskyy Clinical Oncology Centre

    Ivano-Frankivsk, 76018, Ukraine

  • Regional Cancer Care Associates

    Sparta, New Jersey, 78071, United States

  • Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan

    Ufa, 450054, Russia

  • SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary

    Arkhangelsk, 163045, Russia

  • SC Medisprof SRL

    Cluj-Napoca, 400124, Romania

  • SC Oncomed SRL

    Timișoara, 300239, Romania

  • Saint Bernards Medical Center

    Jonesboro, Arkansas, 72401, United States

  • Specialized Hospital for Active Treatment of Oncology EAD

    Sofia, 1756, Bulgaria

  • Spitalul Clinic al Cailor Ferate Cluj Napoca

    Cluj-Napoca, 400015, Romania

  • State Institution of Public Health

    Ryazan, 390011, Russia

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

    Sochi, 354057, Russia

  • State Institution of Public Health Tambov Regional Oncology Dispensary

    Tambov, 390013, Russia

  • State budget institution of public health Pyatigorsk oncology dispensary

    Pyatigorsk, 357502, Russia

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

    Szeged, 6720, Hungary

  • The Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104, United States

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edirne, 22030, Turkey (Türkiye)

  • Transcarpathian Regional Clinical Oncological Dispensary

    Uzhhorod, 88000, Ukraine

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

    Matosinhos Municipality, 4464-513, Portugal

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090, Austria

  • University Hospital of Patras

    Pátrai, 26504, Greece

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-780, Poland

  • VM Medical Park Samsun Hastanesi

    Samsun, 55200, Turkey (Türkiye)

  • Vencer e Oncoclinica

    Teresina, Piauí, 64049-200, Brazil

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    Biała Podlaska, 21-500, Poland

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902, United States

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