Breast Cancer Clinical Trial

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

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

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Full 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.

View Eligibility Criteria

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). 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 days. 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. 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 before the 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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

162

Study ID:

NCT03937154

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 107 Locations for this study

See Locations Near You

Saint Bernards Medical Center
Jonesboro Arkansas, 72401, United States
Pacific Cancer Medical Center Inc
Anaheim California, 92801, United States
University of California at Irvine Medical Center
Orange California, 92868, United States
Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction Colorado, 81505, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Mid Florida Hematology and Oncology Centers PA
Orange City Florida, 32763, United States
Saint Alphonsus Regional Medical Center
Boise Idaho, 83706, United States
Orchard Healthcare Research Inc
Skokie Illinois, 60076, United States
Christus Saint Frances Cabrini Hospital
Alexandria Louisiana, 71301, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
CHRISTUS Highland Cancer Treatment Center
Shreveport Louisiana, 71105, United States
Mercy Medical Center
Baltimore Maryland, 21202, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg Mississippi, 39401, United States
Oncology Hematology Associates
Springfield Missouri, 65807, United States
Regional Cancer Care Associates
Sparta New Jersey, 78071, United States
Broome Oncology LLC
Binghamton New York, 13905, United States
Saint Lukes University Health Network
Bethlehem Pennsylvania, 18015, United States
The Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Medical Oncology Associates PS
Spokane Washington, 99208, United States
Yakima Valley Memorial Hospital
Yakima Washington, 98902, United States
Instituto Oncologico Cordoba
Ciudad de Cordoba Córdoba, X5002, Argentina
Centro Medico Austral
Ciudad Autónoma de Buenos Aires Distrito Federal, C1019, Argentina
Centro de Investigaciones Clínicas Clínica Viedma
Viedma Río Negro, 8500, Argentina
Medizinische Universitaet Innsbruck
Innsbruck , 6020, Austria
Instituto de Oncologia do Parana
Curitba Paraná, 81520, Brazil
Vencer e Oncoclinica
Teresina Piauí, 64049, Brazil
Centro de Pesquisa da Serra Gaucha - Cepesg
Caxias do Sul Rio Grande Do Sul, 95020, Brazil
Catarina Pesquisa Clinica
Itajaí Santa Catarina, 88301, Brazil
Loema Instituto de Pesquisa Clinica & Consultores Ltda
Campinas São Paulo, 13010, Brazil
Casa de Saude Santa Marcelina
Sao Paulo São Paulo, 08270, Brazil
Complex Oncology Center - Ruse EOOD
Ruse , 7002, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia , 1632, Bulgaria
Specialized Hospital for Active Treatment of Oncology EAD
Sofia , 1756, Bulgaria
James Lind Centro de Investigacion del Cancer
Temuco Cautín, 48008, Chile
Orlandi Oncologia
Santiago , 75007, Chile
Oncomedica Imat
Monteria Córdoba, 23000, Colombia
Centro Medico Imbanaco
Cali Valle Del Cauca, 76004, Colombia
Agios Savvas Anticancer Hospital
Athens , 115 2, Greece
Henry Dunant Hospital Center
Athens , 11526, Greece
Sotiria General Hospital
Athens , 11527, Greece
Attikon University Hospital
Athens , 12462, Greece
University Hospital of Heraklion
Heraklion - Crete , 71500, Greece
Agios Loukas Clinic
Thessaloniki , 55236, Greece
Iatriko Diavalkaniko Thessalonikis
Thessaloniki , 57001, Greece
Semmelweis Egyetem
Budapest , 1083, Hungary
Veszprem Megyei Tudogyogyintezet Farkasgyepu
Farkasgyepu , 8582, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Gyor , 9024, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar , 8000, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
Szolnok , 5004, Hungary
Tudogyogyintezet Torokbalint
Torokbalint , 2045, Hungary
Oncotech
La Paz Baja California Sur, 23040, Mexico
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
San Luis Potosi San Luis Potosí, 78200, Mexico
Centro Medico Nacional Siglo XXI
Mexico , 06720, Mexico
Oaxaca Site Management Organization SC
Oaxaca , 68000, Mexico
Hospital Goyeneche
Arequipa , 04001, Peru
Oncosalud
Lima , 15036, Peru
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
Brzeziny , 95-06, Poland
Szpital Kliniczny im Heliodora Swiecickiego UM im Karola Marcinkowskiego w Poznaniu
Poznan , 60-56, Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemysl , 37-70, Poland
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
Lisboa , 1769-, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos , 4464-, Portugal
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto , 4099-, Portugal
Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao
Porto , 4200-, Portugal
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest , 02232, Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest , 02233, Romania
Spitalul Clinic Coltea
Bucharest , 03017, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj Napoca , 40001, Romania
Institutul Regional de Oncologie Iasi
Iasi , 70048, Romania
Spitalul Municipal Ploiesti
Ploiesti , 10033, Romania
SC Oncomed SRL
Timisoara , 30023, Romania
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
Arkhangelsk , 16304, Russian Federation
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
Kazan , 42002, Russian Federation
Medsi Group
Moscow Region , 14344, Russian Federation
State Healthcare Institution Goroda Moskvi City Clinical Hospital 1
Moscow , 11904, Russian Federation
Clinical hospital 2, Group of companies medsi
Moscow , 12528, Russian Federation
LLC Tonus
Nizhniy Novgorod , 60308, Russian Federation
Omsk Regional Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
State budget institution of public health Pyatigorsk oncology dispensary
Pyatigorsk , 35750, Russian Federation
State Institution of Public Health
Ryazan , 39001, Russian Federation
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
Sochi , 35405, Russian Federation
State Institution of Public Health Tambov Regional Oncology Dispensary
Tambov , 39001, Russian Federation
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
Ufa , 45005, Russian Federation
Hospital Clinico Universitario San Cecilio
Granada Andalucía, 18016, Spain
Hospital Universitario Nuestra Señora de Valme
Sevilla Andalucía, 41013, Spain
Hospital Clinico Universitario de Salamanca
Salamanca Castilla León, 37007, Spain
Instituto Oncologico IOB
Barcelona Cataluña, 08023, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon Comunidad Valenciana, 12002, Spain
Hospital Santa Maria Nai
Ourense Galicia, 32005, Spain
Hospital Universitario Madrid Sanchinarro
Madrid , 28050, Spain
Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
Ankara , 06010, Turkey
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara , 06200, Turkey
Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho
Ankara , 06280, Turkey
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli , 20070, Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne , 22030, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul , 34098, Turkey
Pendik Egitim Arastirma Hastanesi
Istanbul , 34890, Turkey
Izmir Ataturk Egitim ve Arastirma Hastanesi
Izmir , 35150, Turkey
Medical Point Izmir Hastanesi
Izmir , 35575, Turkey
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
Kocaeli , 41380, Turkey
Necmettin Erbakan Universitesi Meram Tıp Fakültesi
Konya , 42090, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya , 44280, Turkey
Namik Kemal Universitesi Hastanesi
Tekirdag , 59100, Turkey
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
Chernivtsi , 58013, Ukraine
Transcarpathian Regional Clinical Oncological Dispensary
Uzhgorod , 88011, Ukraine
Vinnytsya Regional Clinical Oncological Dispensary
Vinnytsia , 21029, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

162

Study ID:

NCT03937154

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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