|
Previous or Current Medical Conditions
|
|
|
|
|
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 470 msec, pericardial disease, or myocardial infarction
|
|
|
|
|
Major surgery ≤ 28 days or minor surgery ≤ 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 both stable and suitable for continued therapeutic anticoagulation during trial participation
|
|
|
|
|
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months of screening
|
|
|
|
|
Evidence of active infection within 2 weeks prior to 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 chronic hepatitis B or C 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 (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
|
|
|
|
|
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 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
|
|
|
|
|
Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura)
|
|
|
|
|
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 <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 1 x 109/L) on the day of initiation of
|
|
|
|
|
Other Exclusions
|
|
|
|
|
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 30 mL/min using the Cockcroft-Gault
|
|
|
|
|
estimated creatinine clearance as assessed by local laboratory during screening. If
|
|
|
|
|
local laboratory results are not available, use central laboratory results
|
|
|
|
|
Abnormal liver function (total bilirubin 3X ULN; alanine aminotransferase [ALT] or
|
|
|
|
|
Subject has known sensitivity to any of the products to be administered during dosing
|
|
|
|
|
aspartate aminotransferase [AST] 3X ULN for subjects without liver metastases or 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
|
|
|
|
|
Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed
|
|
|
|
|
during treatment and for an additional 6 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 6 months after treatment (and
|
|
|
|
|
chemotherapy) discontinuation
|
|
|
|
|
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 6 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 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 period of 6 months
|
|
|
|
|
after treatment (and chemotherapy) discontinuation
|
|
|
|
|
Male subjects unwilling to abstain from donating sperm during treatment (and
|
|
|
|
|
chemotherapy) and for an additional 6 months after treatment (and chemotherapy)
|
|
|
|
|
discontinuation
|
|
|
|