New drug may keep chemo on track for lung, ovarian, and breast cancer patients
NCT ID NCT03937154
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether romiplostim can prevent chemotherapy delays or dose reductions caused by low platelet counts in people with lung, ovarian, or breast cancer. About 145 adults will receive either romiplostim or a placebo alongside their chemotherapy. The goal is to help patients complete their full chemo schedule on time.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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145 people
The number who actually took part.
- Started
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Feb 2020
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Agios Loukas Clinic
Thessaloniki, 55236, Greece
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Agios Savvas Anticancer Hospital
Athens, 11522, Greece
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Alexandra Hospital
Athens, 11528, Greece
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American Oncology Partners, PA
Bethesda, Maryland, 20817, United States
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Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
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Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
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Attikon University Hospital
Athens, 12462, Greece
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Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
Kazan', 420029, Russia
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Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul, 34480, Turkey (Türkiye)
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Broome Oncology LLC
Binghamton, New York, 13905, United States
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Casa de Saude Santa Marcelina
São Paulo, São Paulo, 08270-120, Brazil
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Centro Medico Austral
Buenos Aires, Distrito Federal, C1019ABS, Argentina
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Centro Medico Imbanaco
Cali, Valle del Cauca Department, 760042, Colombia
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Centro Medico Nacional Siglo XXI
México, 06720, Mexico
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Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
San Luis Potosí City, San Luis Potosí, 78200, Mexico
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Centro de Diagnostico Investigacion y Tratamiento
Salta, 4400, Argentina
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Centro de Investigaciones Clínicas Clínica Viedma
Viedma, Río Negro Province, 8500, Argentina
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Centro de Pesquisa da Serra Gaucha - Cepesg
Caxias do Sul, Rio Grande do Sul, 95020-450, Brazil
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Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20-090, Poland
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Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, 85-796, Poland
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Christus Highland Cancer Treatment Center
Shreveport, Louisiana, 71105, United States
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Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, 71301, United States
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Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220, Brazil
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Clinical hospital 2, Group of companies medsi
Moscow, 125284, Russia
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Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
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Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
Chernivtsi, 58013, Ukraine
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Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
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Complex Oncology Center - Ruse EOOD
Rousse, 7002, Bulgaria
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Consorcio Hospitalario Provincial de Castellon
Castellon, Valencia, 12002, Spain
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Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 06200, Turkey (Türkiye)
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Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, 53-413, Poland
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Farkasgyepui Tudogyogyintezet
Farkasgyepű, 8582, Hungary
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Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
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Great Falls Clinic
Great Falls, Montana, 59405, United States
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Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024, Hungary
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Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401, United States
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Henry Dunant Hospital Center
Athens, 11526, Greece
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Hospital Clinico Universitario San Cecilio
Granada, Andalusia, 18016, Spain
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Hospital Clinico Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
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Hospital Goyeneche
Arequipa, 04001, Peru
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Hospital Santa Maria Nai
Ourense, Galicia, 32005, Spain
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Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
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Hospital Universitario Nuestra Señora de Valme
Seville, Andalusia, 41013, Spain
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Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
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Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
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Hospital de Amor
Barretos, São Paulo, 14784-400, Brazil
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Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
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Iatriko Diavalkaniko Thessalonikis
Thessaloniki, 57001, Greece
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Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, 44280, Turkey (Türkiye)
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Instituto Oncologico Cordoba
Córdoba, Córdoba Province, X5002HWE, Argentina
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Instituto Oncologico IOB
Barcelona, Catalonia, 08023, Spain
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Instituto de Oncologia do Parana
Curitba, Paraná, 81520-060, Brazil
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Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
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Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, 022328, Romania
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Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, 022338, Romania
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Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
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Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
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Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575, Turkey (Türkiye)
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Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi
Izmir, 35150, Turkey (Türkiye)
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James Lind Centro de Investigacion del Cancer
Temuco, Cautín, 4800827, Chile
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Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5004, Hungary
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Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41380, Turkey (Türkiye)
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LLC Tonus
Nizhny Novgorod, 603089, Russia
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Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59075-740, Brazil
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Loema Instituto de Pesquisa Clinica e Consultores Ltda - Clinica Loema
Campinas, São Paulo, 13010-001, Brazil
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Los Angeles Cancer Network
Anaheim, California, 92801, United States
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Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, 34890, Turkey (Türkiye)
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Medical Oncology Associates PS
Spokane, Washington, 99208, United States
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Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
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Medsi Group
Moscow Region, 143442, Russia
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Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
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Memorial Healthcare International SRL
Bucharest, 013812, Romania
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Mercy Medical Center
Baltimore, Maryland, 21202, United States
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Metaxa Anticancer Hospital
Piraeus, 18537, Greece
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Mid Florida Hematology and Oncology Centers PA
Orange City, Florida, 32763, United States
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Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, 1632, Bulgaria
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Namik Kemal Universitesi Hastanesi
Tekirdağ, 59100, Turkey (Türkiye)
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Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
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Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Konya, 42090, Turkey (Türkiye)
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Oaxaca Site Management Organization SC
Oaxaca City, 68000, Mexico
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Ocala Oncology Center
Ocala, Florida, 34474, United States
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Omsk Regional Clinical Oncology Dispensary
Omsk, 644013, Russia
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Oncolab
Craiova, 200385, Romania
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Oncology Hematology Associates
Springfield, Missouri, 65807, United States
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Oncomedica Imat
Montería, Departamento de Córdoba, 230002, Colombia
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Oncosalud
Lima, 15036, Peru
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Oncotech
La Paz, Baja California Sur, 23040, Mexico
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Orchard Healthcare Research Inc
Skokie, Illinois, 60076, United States
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Orlandi Oncologia
Santiago, 7500713, Chile
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Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20070, Turkey (Türkiye)
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Phylasis Clinical Research
Cuautitlán Izcalli, 54769, Mexico
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Phylasis Clinicas Research Toluca
Toluca, 50090, Mexico
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Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
Brzeziny, 95-060, Poland
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Provita Centrum Medyczne Spzoo
Tomaszów Mazowiecki, 97-200, Poland
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Pérola Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamaria Ltda
São Paulo, 01317-000, Brazil
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Reformatus Pulmonologiai Centrum
Törökbálint, 2045, Hungary
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Regional Cancer Care Associates
Sparta, New Jersey, 78071, United States
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Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
Ufa, 450054, Russia
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SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
Arkhangelsk, 163045, Russia
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SC Medisprof SRL
Cluj-Napoca, 400058, Romania
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SC Oncomed SRL
Timișoara, 300239, Romania
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Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010, Turkey (Türkiye)
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Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho
Ankara, 06280, Turkey (Türkiye)
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Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
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Saint Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
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Saint Lukes University Health Network
Bethlehem, Pennsylvania, 18015, United States
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Sakarya Egitim ve Arastirma Hastanesi
Sakarya, 54290, Turkey (Türkiye)
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Semmelweis Egyetem
Budapest, 1083, Hungary
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Sotiria General Hospital
Athens, 11527, Greece
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Specialized Hospital for Active Treatment of Oncology EAD
Sofia, 1756, Bulgaria
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Specjalistyczny Szpital im Dra Alfreda Sokolowskiego
Wałbrzych, 58-309, Poland
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Spitalul Clinic Coltea
Bucharest, 030171, Romania
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Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
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Spitalul Universitar de Urgenta Elias
Bucharest, 011461, Romania
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State Healthcare Institution Goroda Moskvi City Clinical Hospital 1
Moscow, 119049, Russia
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State Institution of Public Health
Ryazan, 390011, Russia
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State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
Sochi, 354057, Russia
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State Institution of Public Health Tambov Regional Oncology Dispensary
Tambov, 390013, Russia
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State budget institution of public health Pyatigorsk oncology dispensary
Pyatigorsk, 357502, Russia
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Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie
Koszalin, 75-581, Poland
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The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
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Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, 22030, Turkey (Türkiye)
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Transcarpathian Regional Clinical Oncological Dispensary
Uzhhorod, 88011, Ukraine
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Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
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Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
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Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, 4099-001, Portugal
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Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, 4200-319, Portugal
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University Hospital of Heraklion
Heraklion - Crete, 71500, Greece
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University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
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University of California Irvine
Orange, California, 92868, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of Miami School of Medicine
Miami, Florida, 33136, United States
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Uniwersytecki Szpital Kliniczny nr 2 Pum w Szczecinie
Szczecin, 70-111, Poland
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Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569, Poland
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Vencer e Oncoclinica
Teresina, Piauí, 64049-200, Brazil
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Vinnytsya Regional Clinical Oncological Dispensary
Vinnytsia, 21029, Ukraine
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Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, 37-700, Poland
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Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
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