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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03937154

Studienbeginn:
Februar 2020

Letztes Update:
09.08.2024

Wirkstoff:
Romiplostim, Placebo

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Thrombocytopenia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 128)

Saint Bernards Medical Center
72401 Jonesboro
United StatesRekrutierend» Google-Maps
Los Angeles Cancer Network
92801 Anaheim
United StatesAbgeschlossen» Google-Maps
University of California Irvine
92868 Orange
United StatesAbgeschlossen» Google-Maps
Colorado West Healthcare System dba Grand Valley Oncology
81505 Grand Junction
United StatesAbgebrochen» Google-Maps
University of Miami School of Medicine
33136 Miami
United StatesRekrutierend» Google-Maps
Mid Florida Hematology and Oncology Centers PA
32763 Orange City
United StatesRekrutierend» Google-Maps
Saint Alphonsus Regional Medical Center
83706 Boise
United StatesRekrutierend» Google-Maps
Orchard Healthcare Research Inc
60076 Skokie
United StatesRekrutierend» Google-Maps
Christus Saint Frances Cabrini Hospital
71301 Alexandria
United StatesAbgebrochen» Google-Maps
University Medical Center New Orleans
70112 New Orleans
United StatesAbgebrochen» Google-Maps
Christus Highland Cancer Treatment Center
71105 Shreveport
United StatesRekrutierend» Google-Maps
American Oncology Partners, PA
20817 Bethesda
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
Hattiesburg Clinic Hematology/Oncology
39401 Hattiesburg
United StatesAbgebrochen» Google-Maps
Oncology Hematology Associates
65807 Springfield
United StatesAbgeschlossen» Google-Maps
Great Falls Clinic
59405 Great Falls
United StatesRekrutierend» Google-Maps
Nebraska Cancer Specialists
68130 Omaha
United StatesRekrutierend» Google-Maps
Regional Cancer Care Associates
78071 Sparta
United StatesAbgebrochen» Google-Maps
Saint Lukes University Health Network
18015 Bethlehem
United StatesAbgeschlossen» Google-Maps
The Center for Cancer and Blood Disorders
76104 Fort Worth
United StatesAbgeschlossen» Google-Maps
Community Cancer Trials of Utah
84403 Ogden
United StatesRekrutierend» Google-Maps
Medical Oncology Associates PS
99208 Spokane
United StatesRekrutierend» Google-Maps
Yakima Valley Memorial Hospital
98902 Yakima
United StatesRekrutierend» Google-Maps
Instituto Oncologico Cordoba
X5002HWE Ciudad de Cordoba
ArgentinaRekrutierend» Google-Maps
Centro Medico Austral
C1019ABS Ciudad Autónoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
Centro de Investigaciones Clínicas Clínica Viedma
8500 Viedma
ArgentinaRekrutierend» Google-Maps
Centro de Diagnostico Investigacion y Tratamiento
4400 Salta
ArgentinaRekrutierend» Google-Maps
Medizinische Universitaet Innsbruck
6020 Innsbruck
AustriaAbgebrochen» Google-Maps
Instituto de Oncologia do Parana
81520-060 Curitba
BrazilRekrutierend» Google-Maps
Liga Norte-Riograndense Contra O Cancer
59075-740 Natal
BrazilRekrutierend» Google-Maps
Centro de Pesquisa da Serra Gaucha - Cepesg
95020-450 Caxias do Sul
BrazilAbgebrochen» Google-Maps
Centro de Pesquisa Clínica Associação Hospitalar Moinhos de Vento
90035-001 Porto Alegre
BrazilRekrutierend» Google-Maps
Catarina Pesquisa Clinica
88301-220 Itajaí
BrazilRekrutierend» Google-Maps
Loema Instituto de Pesquisa Clinica e Consultores Ltda
13010-001 Campinas
BrazilAbgebrochen» Google-Maps
Casa de Saude Santa Marcelina
08270-120 Sao Paulo
BrazilRekrutierend» Google-Maps
Hospital de Base de Sao Jose do Rio Preto
15090-000 São José do Rio Preto
BrazilRekrutierend» Google-Maps
Complex Oncology Center - Ruse EOOD
7002 Ruse
BulgariaAbgebrochen» Google-Maps
Multiprofile Hospital for Active Treatment Serdika EOOD
1632 Sofia
BulgariaAbgebrochen» Google-Maps
Specialized Hospital for Active Treatment of Oncology EAD
1756 Sofia
BulgariaAbgebrochen» Google-Maps
James Lind Centro de Investigacion del Cancer
4800827 Temuco
ChileAbgebrochen» Google-Maps
Agios Savvas Anticancer Hospital
11522 Athens
GreeceRekrutierend» Google-Maps
University Hospital of Heraklion
71500 Heraklion - Crete
GreeceRekrutierend» Google-Maps
Iatriko Diavalkaniko Thessalonikis
57001 Thessaloniki
GreeceRekrutierend» Google-Maps
Farkasgyepui Tudogyogyintezet
8582 Farkasgyepu
HungaryAbgebrochen» Google-Maps
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
9024 Gyor
HungaryAbgebrochen» Google-Maps
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
8000 Szekesfehervar
HungaryAbgebrochen» Google-Maps
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
5004 Szolnok
HungaryAbgebrochen» Google-Maps
Reformatus Pulmonologiai Centrum
2045 Torokbalint
HungaryAbgebrochen» Google-Maps
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc
78200 San Luis Potosi
MexicoRekrutierend» Google-Maps
Centro Medico Nacional Siglo XXI
06720 Mexico
MexicoRekrutierend» Google-Maps
Oaxaca Site Management Organization SC
68000 Oaxaca
MexicoRekrutierend» Google-Maps
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o
95-060 Brzeziny
PolandAbgebrochen» Google-Maps
Centrum Onkologii im prof Franciszka Lukaszczyka w Bydgoszczy
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Uniwersytecki Szpital Kliniczny w Poznaniu
60-569 Poznan
PolandRekrutierend» Google-Maps
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
37-700 Przemysl
PolandRekrutierend» Google-Maps
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente
1769-001 Lisboa
PortugalAbgebrochen» Google-Maps
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
4464-513 Matosinhos
PortugalRekrutierend» Google-Maps
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
4099-001 Porto
PortugalAbgebrochen» Google-Maps
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
4200-319 Porto
PortugalAbgebrochen» Google-Maps
Spitalul Universitar de Urgenta Elias
011461 Bucharest
RomaniaRekrutierend» Google-Maps
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
022328 Bucharest
RomaniaAbgeschlossen» Google-Maps
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
022338 Bucharest
RomaniaRekrutierend» Google-Maps
Memorial Healthcare International SRL
013812 Bucuresti
RomaniaRekrutierend» Google-Maps
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
400015 Cluj Napoca
RomaniaRekrutierend» Google-Maps
Institutul Regional de Oncologie Iasi
700483 Iasi
RomaniaAbgeschlossen» Google-Maps
Spitalul Municipal Ploiesti
100337 Ploiesti
RomaniaRekrutierend» Google-Maps
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary
163045 Arkhangelsk
Russian FederationRekrutierend» Google-Maps
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan
420029 Kazan
Russian FederationRekrutierend» Google-Maps
Medsi Group
143442 Moscow Region
Russian FederationRekrutierend» Google-Maps
State Healthcare Institution Goroda Moskvi City Clinical Hospital 1
119049 Moscow
Russian FederationAbgebrochen» Google-Maps
Clinical hospital 2, Group of companies medsi
125284 Moscow
Russian FederationRekrutierend» Google-Maps
LLC Tonus
603089 Nizhniy Novgorod
Russian FederationAbgeschlossen» Google-Maps
Omsk Regional Clinical Oncology Dispensary
644013 Omsk
Russian FederationRekrutierend» Google-Maps
State budget institution of public health Pyatigorsk oncology dispensary
357502 Pyatigorsk
Russian FederationAbgebrochen» Google-Maps
State Institution of Public Health
390011 Ryazan
Russian FederationAbgebrochen» Google-Maps
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region
354057 Sochi
Russian FederationAbgebrochen» Google-Maps
State Institution of Public Health Tambov Regional Oncology Dispensary
390013 Tambov
Russian FederationAbgebrochen» Google-Maps
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan
450054 Ufa
Russian FederationRekrutierend» Google-Maps
Hospital Clinico Universitario San Cecilio
18016 Granada
SpainRekrutierend» Google-Maps
Hospital Universitario Nuestra Señora de Valme
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Salamanca
37007 Salamanca
SpainAbgebrochen» Google-Maps
Consorcio Hospitalario Provincial de Castellon
12002 Castellon
SpainRekrutierend» Google-Maps
Hospital Universitario de Fuenlabrada
28942 Fuenlabrada
SpainRekrutierend» Google-Maps
Hospital Universitario Madrid Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
06010 Ankara
TurkeyRekrutierend» Google-Maps
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
06200 Ankara
TurkeyAbgebrochen» Google-Maps
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
06200 Ankara
TurkeyRekrutierend» Google-Maps
Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho
06280 Ankara
TurkeyAbgeschlossen» Google-Maps
Ankara Bilkent Sehir Hastanesi
06800 Ankara
TurkeyRekrutierend» Google-Maps
Pamukkale Universitesi Tip Fakultesi Hastanesi
20070 Denizli
TurkeyRekrutierend» Google-Maps
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
22030 Edirne
TurkeyAbgebrochen» Google-Maps
Istanbul Universitesi Cerrahpasa Tip Fakultesi
34098 Istanbul
TurkeyAbgebrochen» Google-Maps
Marmara Universitesi Tip Fakultesi Hastanesi
34890 Istanbul
TurkeyRekrutierend» Google-Maps
Izmir Ataturk Egitim ve Arastirma Hastanesi
35150 Izmir
TurkeyRekrutierend» Google-Maps
Izmir Ekonomi Universitesi Medical Point Hastanesi
35575 Izmir
TurkeyRekrutierend» Google-Maps
Kocaeli Universitesi Tip Fakultesi Hastanesi
41380 Kocaeli
TurkeyRekrutierend» Google-Maps
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
42090 Konya
TurkeyRekrutierend» Google-Maps
Inonu Universitesi Turgut Ozal Tip Merkezi
44280 Malatya
TurkeyRekrutierend» Google-Maps
Sakarya Egitim ve Arastirma Hastanesi
54290 Sakarya
TurkeyRekrutierend» Google-Maps
Namik Kemal Universitesi Hastanesi
59100 Tekirdag
TurkeyRekrutierend» Google-Maps
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary
58013 Chernivtsi
UkraineRekrutierend» Google-Maps
Transcarpathian Regional Clinical Oncological Dispensary
88011 Uzhgorod
UkraineRekrutierend» Google-Maps
Vinnytsya Regional Clinical Oncological Dispensary
21029 Vinnytsya
UkraineRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Incidence of either a chemotherapy dose delay or reduction (Time Frame - 48 days):
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



Secondary outcome:

1. Depth of Platelet Count (Time Frame - 48 days):
the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period

2. Time to First platelet response (Time Frame - 7 days):
The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days

3. the duration-adjusted event rate of ≥ grade 2 bleeding events (Time Frame - 48 days):
the duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale

4. Overall survival (Time Frame - 1 Year):
1-year overall survival

5. Proportion of subjects with at leat 1 incidence of platelet transfusion (Time Frame - 48 days):
platelet transfusion(s) during the treatment period

6. proportion of patients achieving platelet count >= 100 x 10 9/L (Time Frame - 7 days):
7 days after 3rd dose of IP with no transfusions in preceding 7 days

7. The subject incidence of adverse events (Time Frame - 36 months):
Through end of study, up to 36 months. It will be counted in as an adverse event: any treatment - emergent adverse events, fatal adverse events, serious adverse events, or clinically significant changes in laboratory values.

8. Number of subjects who develop anti-romiplostim antibodies (Time Frame - 36 Months):
Through end of study up to 36 months

9. Number of subjects who develop anti-TPO antibodies (Time Frame - 36 months):
Through end of study, up to 36 months

10. Number of subjects who experience myelodysplastic syndromes (Time Frame - 36 months):
Through end of study, up to 36 months

11. Number of subjects who experience secondary malignancies (Time Frame - 36 months):
Through end of study, up to 36 months

Studien-Arme

  • Experimental: 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.
  • Placebo Comparator: 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.

Geprüfte Regime

  • Romiplostim (Nplate):
    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:
    Placebo comparator

Quelle: ClinicalTrials.gov


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