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:
22.12.2020
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
Study Director
Amgen
Kontakt
Kontakt:
Phone: 866-572-6436
E-Mail: medinfo@amgen.com» Kontaktdaten anzeigen
Studienlocations (3 von 80)
Research Site
72401 Jonesboro
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92801 Anaheim
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32763 Orange City
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72401 Jonesboro
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92801 Anaheim
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32763 Orange City
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83706 Boise
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71301 Alexandria
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70112 New Orleans
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71105 Shreveport
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21202 Baltimore
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20817 Bethesda
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02114 Boston
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39401 Hattiesburg
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65807 Springfield
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07871 Sparta
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13905 Binghamton
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76104 Fort Worth
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5000 Cordoba
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C1019ABS Ciudad Autónoma de Buenos Aires
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8500 Viedma
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6020 Innsbruck
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81520-060 Curitba
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64049-200 Teresina
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95020-450 Caxias do Sul
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08270-120 Sao Paulo
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7002 Ruse
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1632 Sofia
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1756 Sofia
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7500713 Santiago
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1083 Budapest
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8582 Farkasgyepu
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357502 Pyatigorsk
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18016 Granada
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32005 Ourense
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28050 Madrid
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Alle anzeigen 83706 Boise
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71301 Alexandria
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70112 New Orleans
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71105 Shreveport
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21202 Baltimore
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20817 Bethesda
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39401 Hattiesburg
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65807 Springfield
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07871 Sparta
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13905 Binghamton
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76104 Fort Worth
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5000 Cordoba
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C1019ABS Ciudad Autónoma de Buenos Aires
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8500 Viedma
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6020 Innsbruck
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81520-060 Curitba
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64049-200 Teresina
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95020-450 Caxias do Sul
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13010-001 Campinas
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08270-120 Sao Paulo
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7002 Ruse
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1632 Sofia
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1756 Sofia
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7500713 Santiago
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230002 Monteria
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760042 Cali
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11527 Athens
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12462 Athens
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71110 Heraklion - Crete
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57001 Thessaloniki
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1083 Budapest
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8582 Farkasgyepu
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8000 Szekesfehervar
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5004 Szolnok
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2045 Torokbalint
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23040 La Paz
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78200 San Luis Potosi
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68000 Oaxaca
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04001 Arequipa
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15036 Lima
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95-060 Brzeziny
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60-569 Poznan
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4464-513 Matosinhos
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022328 Bucharest
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022338 Bucharest
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030171 Bucharest
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400015 Cluj Napoca
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700483 Iasi
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100337 Ploiesti
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300239 Timisoara
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163045 Arkhangelsk
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143442 Moscow Region
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119049 Moscow
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125284 Moscow
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603089 Nizhniy Novgorod
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357502 Pyatigorsk
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390011 Ryazan
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354057 Sochi
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390013 Tambov
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18016 Granada
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37007 Salamanca
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32005 Ourense
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28050 Madrid
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06200 Ankara
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06280 Ankara
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20070 Denizli
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22030 Edirne
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34098 Istanbul
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34890 Istanbul
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35575 Izmir
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41380 Kocaeli
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44280 Malatya
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59100 Tekirdag
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58013 Chernivtsi
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88011 Uzhgorod
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21029 Vinnytsia
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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 < 75 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 10-22 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 NSCLC, breast
cancer, or ovarian cancer, 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.
- Subjects must have a platelet count less than 75 x 10 9/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 central. laboratory assessment at screening.
- Known active of chronic hepatitis C or hepatitis B infection. Subjects without a
documented diagnosis in their medical history will require a central laboratory
assessment at screening. 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 planned 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 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 less than 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 central laboratory
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 central laboratory during screening.
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