Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

NCT03937154 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20170770
• Study Type: interventional
• Target: 145
• Locations: 18 countries
• Sites: 139

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

Conditions

Chemotherapy-induced Thrombocytopenia

Keywords

Chemotherapy-induced thrombocytopenia; Non-small Cell Lung Cancer; Ovarian Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of either a chemotherapy dose delay or reduction

  No thrombocytopenia-induced modification of any myelosuppressive agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L

  48 days

Secondary Outcomes (11)

• Depth of Platelet Count

  48 days

• Time to First platelet response

  7 days

• the duration-adjusted event rate of ≥ grade 2 bleeding events

  48 days

• Overall survival

  1 Year

• Proportion of subjects with at leat 1 incidence of platelet transfusion

  48 days

Study Arms (2)

Romiplostim

EXPERIMENTAL

The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Drug: Romiplostim

Placebo

PLACEBO COMPARATOR

The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Drug: Placebo

Interventions

Romiplostim DRUG

This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer

Also known as: Nplate

Romiplostim

Placebo DRUG

Placebo comparator

Placebo

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (139)

Saint Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Los Angeles Cancer Network

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

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Mid Florida Hematology and Oncology Centers PA

Orange City, Florida, 32763, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

University of Chicago

Chicago, Illinois, 60637, 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

Boston, Massachusetts, 02114, United States

Location

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Regional Cancer Care Associates

Sparta, New Jersey, 78071, United States

Location

Broome Oncology LLC

Binghamton, New York, 13905, United States

Location

Saint Lukes University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Community Cancer Trials of Utah

Ogden, Utah, 84405, United States

Location

Medical Oncology Associates PS

Spokane, Washington, 99208, United States

Location

Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Instituto Oncologico Cordoba

Córdoba, Córdoba Province, X5002HWE, Argentina

Location

Centro Medico Austral

Buenos Aires, Distrito Federal, C1019ABS, 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

Medizinische Universitaet Innsbruck

Innsbruck, 6020, Austria

Location

Instituto de Oncologia do Parana

Curitba, Paraná, 81520-060, Brazil

Location

Vencer e Oncoclinica

Teresina, Piauí, 64049-200, Brazil

Location

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Centro de Pesquisa da Serra Gaucha - Cepesg

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

Location

Associação Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Hospital de Amor

Barretos, São Paulo, 14784-400, Brazil

Location

Loema Instituto de Pesquisa Clinica e Consultores Ltda - Clinica Loema

Campinas, São Paulo, 13010-001, Brazil

Location

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Casa de Saude Santa Marcelina

São Paulo, São Paulo, 08270-120, Brazil

Location

Pérola Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamaria Ltda

São Paulo, 01317-000, Brazil

Location

Complex Oncology Center - Ruse EOOD

Rousse, 7002, Bulgaria

Location

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, 1632, Bulgaria

Location

Specialized Hospital for Active Treatment of Oncology EAD

Sofia, 1756, Bulgaria

Location

James Lind Centro de Investigacion del Cancer

Temuco, Cautín, 4800827, Chile

Location

Orlandi Oncologia

Santiago, 7500713, Chile

Location

Oncomedica Imat

Montería, Departamento de Córdoba, 230002, Colombia

Location

Centro Medico Imbanaco

Cali, Valle del Cauca Department, 760042, Colombia

Location

Agios Savvas Anticancer Hospital

Athens, 11522, Greece

Location

Henry Dunant Hospital Center

Athens, 11526, Greece

Location

Sotiria General Hospital

Athens, 11527, Greece

Location

Alexandra Hospital

Athens, 11528, Greece

Location

Attikon University Hospital

Athens, 12462, Greece

Location

University Hospital of Heraklion

Heraklion - Crete, 71500, Greece

Location

Metaxa Anticancer Hospital

Piraeus, 18537, Greece

Location

Agios Loukas Clinic

Thessaloniki, 55236, Greece

Location

Iatriko Diavalkaniko Thessalonikis

Thessaloniki, 57001, Greece

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Farkasgyepui Tudogyogyintezet

Farkasgyepű, 8582, Hungary

Location

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

Győr, 9024, Hungary

Location

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

Location

Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, 5004, Hungary

Location

Reformatus Pulmonologiai Centrum

Törökbálint, 2045, Hungary

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

Phylasis Clinical Research

Cuautitlán Izcalli, 54769, Mexico

Location

Centro Medico Nacional Siglo XXI

México, 06720, Mexico

Location

Oaxaca Site Management Organization SC

Oaxaca City, 68000, Mexico

Location

Phylasis Clinicas Research Toluca

Toluca, 50090, Mexico

Location

Hospital Goyeneche

Arequipa, 04001, Peru

Location

Oncosalud

Lima, 15036, Peru

Location

Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

Brzeziny, 95-060, Poland

Location

Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, 85-796, Poland

Location

Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie

Koszalin, 75-581, Poland

Location

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, 20-090, Poland

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569, Poland

Location

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, 37-700, Poland

Location

Uniwersytecki Szpital Kliniczny nr 2 Pum w Szczecinie

Szczecin, 70-111, Poland

Location

Provita Centrum Medyczne Spzoo

Tomaszów Mazowiecki, 97-200, Poland

Location

Specjalistyczny Szpital im Dra Alfreda Sokolowskiego

Wałbrzych, 58-309, Poland

Location

Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

Wroclaw, 53-413, Poland

Location

Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente

Lisbon, 1769-001, Portugal

Location

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

Matosinhos Municipality, 4464-513, Portugal

Location

Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

Porto, 4099-001, Portugal

Location

Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

Porto, 4200-319, Portugal

Location

Spitalul Universitar de Urgenta Elias

Bucharest, 011461, Romania

Location

Memorial Healthcare International SRL

Bucharest, 013812, Romania

Location

Institutul Oncologic, Prof Dr Alexandru Trestioreanu

Bucharest, 022328, Romania

Location

Institutul Oncologic, Prof Dr Alexandru Trestioreanu

Bucharest, 022338, Romania

Location

Spitalul Clinic Coltea

Bucharest, 030171, Romania

Location

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

SC Medisprof SRL

Cluj-Napoca, 400058, Romania

Location

Oncolab

Craiova, 200385, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Spitalul Municipal Ploiesti

Ploieşti, 100337, 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

State Healthcare Institution Goroda Moskvi City Clinical Hospital 1

Moscow, 119049, 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

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 Universitario Nuestra Señora de Valme

Seville, Andalusia, 41013, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Instituto Oncologico IOB

Barcelona, Catalonia, 08023, Spain

Location

Hospital Santa Maria Nai

Ourense, Galicia, 32005, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon, Valencia, 12002, Spain

Location

Hospital Universitario Madrid Sanchinarro

Madrid, 28050, Spain

Location

Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi

Ankara, 06010, Turkey (Türkiye)

Location

Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, 06200, Turkey (Türkiye)

Location

Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho

Ankara, 06280, Turkey (Türkiye)

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, 20070, Turkey (Türkiye)

Location

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Basaksehir Cam ve Sakura Sehir Hastanesi

Istanbul, 34480, Turkey (Türkiye)

Location

Marmara Universitesi Tip Fakultesi Hastanesi

Istanbul, 34890, Turkey (Türkiye)

Location

Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi

Izmir, 35150, Turkey (Türkiye)

Location

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, 35575, Turkey (Türkiye)

Location

Kocaeli Universitesi Tip Fakultesi Hastanesi

Kocaeli, 41380, Turkey (Türkiye)

Location

Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi

Konya, 42090, Turkey (Türkiye)

Location

Inonu Universitesi Turgut Ozal Tip Merkezi

Malatya, 44280, Turkey (Türkiye)

Location

Sakarya Egitim ve Arastirma Hastanesi

Sakarya, 54290, Turkey (Türkiye)

Location

Namik Kemal Universitesi Hastanesi

Tekirdağ, 59100, Turkey (Türkiye)

Location

Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

Chernivtsi, 58013, Ukraine

Location

Transcarpathian Regional Clinical Oncological Dispensary

Uzhhorod, 88011, Ukraine

Location

Vinnytsya Regional Clinical Oncological Dispensary

Vinnytsia, 21029, Ukraine

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Breast Neoplasms

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

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

Model Details: 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 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.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 3, 2019
• Study Start: February 26, 2020
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2027
• Last Updated: January 27, 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

BR (11); US (27); PE (2); BU (3); GR (9); PT (4); ES (9); UA (3); CL (2); AU (1); RU (12); TU (17); PL (10); HU (6); ME (6); AR (4); CO (2); RO (11)