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

NCT ID: NCT03937154

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2027-05-20

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

Detailed Description

This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer. Subjects must have a platelet count ≤ 85 x 10^9/L on day 1 of the study. 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 long-term follow-up (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.

Conditions

Chemotherapy-induced Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Romiplostim

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.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: 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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator

Interventions

Romiplostim

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

Intervention Type: DRUG

Placebo

Placebo comparator

Intervention Type: DRUG

Other Intervention Names

Nplate

Eligibility Criteria

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.
• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Saint Bernards Medical Center

Jonesboro, Arkansas, United States

Los Angeles Cancer Network

Anaheim, California, United States

University of California Irvine

Orange, California, United States

Colorado West Healthcare System dba Grand Valley Oncology

Grand Junction, Colorado, United States

University of Miami School of Medicine

Miami, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

Mid Florida Hematology and Oncology Centers PA

Orange City, Florida, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

University of Chicago

Chicago, Illinois, United States

Orchard Healthcare Research Inc

Skokie, Illinois, United States

Christus Saint Frances Cabrini Hospital

Alexandria, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Christus Highland Cancer Treatment Center

Shreveport, Louisiana, United States

Mercy Medical Center

Baltimore, Maryland, United States

American Oncology Partners, PA

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Great Falls Clinic

Great Falls, Montana, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Regional Cancer Care Associates

Sparta, New Jersey, United States

Broome Oncology LLC

Binghamton, New York, United States

Saint Lukes University Health Network

Bethlehem, Pennsylvania, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Community Cancer Trials of Utah

Ogden, Utah, United States

Medical Oncology Associates PS

Spokane, Washington, United States

Yakima Valley Memorial Hospital

Yakima, Washington, United States

Instituto Oncologico Cordoba

Córdoba, Córdoba Province, Argentina

Centro Medico Austral

Buenos Aires, Distrito Federal, Argentina

Centro de Investigaciones Clínicas Clínica Viedma

Viedma, Río Negro Province, Argentina

Centro de Diagnostico Investigacion y Tratamiento

Salta, , Argentina

Medizinische Universitaet Innsbruck

Innsbruck, , Austria

Instituto de Oncologia do Parana

Curitba, Paraná, Brazil

Vencer e Oncoclinica

Teresina, Piauí, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Centro de Pesquisa da Serra Gaucha - Cepesg

Caxias do Sul, Rio Grande do Sul, Brazil

Associação Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Hospital de Amor

Barretos, São Paulo, Brazil

Loema Instituto de Pesquisa Clinica e Consultores Ltda - Clinica Loema

Campinas, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Casa de Saude Santa Marcelina

São Paulo, São Paulo, Brazil

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

São Paulo, , Brazil

Complex Oncology Center - Ruse EOOD

Rousse, , Bulgaria

Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, , Bulgaria

Specialized Hospital for Active Treatment of Oncology EAD

Sofia, , Bulgaria

James Lind Centro de Investigacion del Cancer

Temuco, Cautín, Chile

Orlandi Oncologia

Santiago, , Chile

Oncomedica Imat

Montería, Departamento de Córdoba, Colombia

Centro Medico Imbanaco

Cali, Valle del Cauca Department, Colombia

Agios Savvas Anticancer Hospital

Athens, , Greece

Henry Dunant Hospital Center

Athens, , Greece

Sotiria General Hospital

Athens, , Greece

Alexandra Hospital

Athens, , Greece

Attikon University Hospital

Athens, , Greece

University Hospital of Heraklion

Heraklion - Crete, , Greece

Metaxa Anticancer Hospital

Piraeus, , Greece

Agios Loukas Clinic

Thessaloniki, , Greece

Iatriko Diavalkaniko Thessalonikis

Thessaloniki, , Greece

Semmelweis Egyetem

Budapest, , Hungary

Farkasgyepui Tudogyogyintezet

Farkasgyepű, , Hungary

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

Győr, , Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, , Hungary

Reformatus Pulmonologiai Centrum

Törökbálint, , Hungary

Oncotech

La Paz, Baja California Sur, Mexico

Centro de Atencion e Investigacion Cardiovascular del Potosi Sc

San Luis Potosí City, San Luis Potosí, Mexico

Phylasis Clinical Research

Cuautitlán Izcalli, , Mexico

Centro Medico Nacional Siglo XXI

México, , Mexico

Oaxaca Site Management Organization SC

Oaxaca City, , Mexico

Phylasis Clinicas Research Toluca

Toluca, , Mexico

Hospital Goyeneche

Arequipa, , Peru

Oncosalud

Lima, , Peru

Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

Brzeziny, , Poland

Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, , Poland

Szpital Wojewodzki imienia Mikolaja Kopernika w Koszalinie

Koszalin, , Poland

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, , Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, , Poland

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, , Poland

Uniwersytecki Szpital Kliniczny nr 2 Pum w Szczecinie

Szczecin, , Poland

Provita Centrum Medyczne Spzoo

Tomaszów Mazowiecki, , Poland

Specjalistyczny Szpital im Dra Alfreda Sokolowskiego

Wałbrzych, , Poland

Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

Wroclaw, , Poland

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

Lisbon, , Portugal

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

Matosinhos Municipality, , Portugal

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

Porto, , Portugal

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

Porto, , Portugal

Spitalul Universitar de Urgenta Elias

Bucharest, , Romania

Memorial Healthcare International SRL

Bucharest, , Romania

Institutul Oncologic, Prof Dr Alexandru Trestioreanu

Bucharest, , Romania

Institutul Oncologic, Prof Dr Alexandru Trestioreanu

Bucharest, , Romania

Spitalul Clinic Coltea

Bucharest, , Romania

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, , Romania

SC Medisprof SRL

Cluj-Napoca, , Romania

Oncolab

Craiova, , Romania

Institutul Regional de Oncologie Iasi

Iași, , Romania

Spitalul Municipal Ploiesti

Ploieşti, , Romania

SC Oncomed SRL

Timișoara, , Romania

SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary

Arkhangelsk, , Russia

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

Kazan', , Russia

State Healthcare Institution Goroda Moskvi City Clinical Hospital 1

Moscow, , Russia

Clinical hospital 2, Group of companies medsi

Moscow, , Russia

Medsi Group

Moscow Region, , Russia

LLC Tonus

Nizhny Novgorod, , Russia

Omsk Regional Clinical Oncology Dispensary

Omsk, , Russia

State budget institution of public health Pyatigorsk oncology dispensary

Pyatigorsk, , Russia

State Institution of Public Health

Ryazan, , Russia

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

Sochi, , Russia

State Institution of Public Health Tambov Regional Oncology Dispensary

Tambov, , Russia

Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan

Ufa, , Russia

Hospital Clinico Universitario San Cecilio

Granada, Andalusia, Spain

Hospital Universitario Nuestra Señora de Valme

Seville, Andalusia, Spain

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Castille and León, Spain

Instituto Oncologico IOB

Barcelona, Catalonia, Spain

Hospital Santa Maria Nai

Ourense, Galicia, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Consorcio Hospitalario Provincial de Castellon

Castellon, Valencia, Spain

Hospital Universitario Madrid Sanchinarro

Madrid, , Spain

Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

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

Ankara, , Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, , Turkey (Türkiye)

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, , Turkey (Türkiye)

Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

Edirne, , Turkey (Türkiye)

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Basaksehir Cam ve Sakura Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Marmara Universitesi Tip Fakultesi Hastanesi

Istanbul, , Turkey (Türkiye)

Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi

Izmir, , Turkey (Türkiye)

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, , Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi Hastanesi

Kocaeli, , Turkey (Türkiye)

Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi

Konya, , Turkey (Türkiye)

Inonu Universitesi Turgut Ozal Tip Merkezi

Malatya, , Turkey (Türkiye)

Sakarya Egitim ve Arastirma Hastanesi

Sakarya, , Turkey (Türkiye)

Namik Kemal Universitesi Hastanesi

Tekirdağ, , Turkey (Türkiye)

Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

Chernivtsi, , Ukraine

Transcarpathian Regional Clinical Oncological Dispensary

Uzhhorod, , Ukraine

Vinnytsya Regional Clinical Oncological Dispensary

Vinnytsia, , Ukraine

Countries

United States; Argentina; Austria; Brazil; Bulgaria; Chile; Colombia; Greece; Hungary; Mexico; Peru; Poland; Portugal; Romania; Russia; Spain; Turkey (Türkiye); Ukraine

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20170770

Identifier Type: -

Identifier Source: org_study_id