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Previous or Current Medical Conditions
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Acute lymphoblastic leukemia
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Acute myeloid leukemia
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Any myeloid malignancy
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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
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Myeloproliferative disease
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Multiple myeloma
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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
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Major surgery ≤ 28 days or minor surgery ≤ 3 days prior to enrollment
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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
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History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months of screening
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Evidence of active infection within 2 weeks prior to first dose of study treatment
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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
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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
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Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
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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
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Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
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Secondary malignancy within the past 5 years except
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Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
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Adequately treated cervical carcinoma in situ without evidence of disease
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Adequately treated breast ductal carcinoma in situ without evidence of disease
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Prostatic intraepithelial neoplasia without evidence of prostate cancer
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Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
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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
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Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura)
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Prior/Concomitant Therapy
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• Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and
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development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or
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any investigational platelet producing agent
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Prior/Concurrent Clinical Study Experience • Currently receiving treatment in another
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investigational device or drug study, or less than 28 days since ending treatment on
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another investigational device or drug study(ies). Other investigational procedures while
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participating in this study are excluded
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Diagnostic Assessments
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Anemia (hemoglobin <80 g/L [8 g/dL]) on the day of initiation of investigational
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product as assessed by local labs. Use of red cell transfusions and erythropoietic
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stimulating agents is permitted throughout the study as per institutional guidelines
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Neutropenia (absolute neutrophil count 1 x 109/L) on the day of initiation of
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Other Exclusions
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investigational product as assessed by local labs. Use of granulocyte-colony
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stimulating factor is permitted throughout the study as per institutional guidelines
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Abnormal renal function with creatinine clearance 30 mL/min using the Cockcroft-Gault
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estimated creatinine clearance as assessed by local laboratory during screening. If
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local laboratory results are not available, use central laboratory results
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Abnormal liver function (total bilirubin 3X ULN; alanine aminotransferase [ALT] or
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Subject has known sensitivity to any of the products to be administered during dosing
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aspartate aminotransferase [AST] 3X ULN for subjects without liver metastases or 5X
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ULN for subjects with liver metastases) as assessed by local laboratory during
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screening. If local laboratory results are not available, use central laboratory
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results
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Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed
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during treatment and for an additional 6 months after treatment (and chemotherapy)
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discontinuation (females of childbearing potential should only be included after a
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confirmed menstrual period and a negative highly sensitive urine or serum pregnancy
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test.)
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Females of childbearing potential unwilling to use a highly effective method of
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contraception during treatment and for an additional 6 months after treatment (and
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chemotherapy) discontinuation
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Males unwilling to use contraception (male condom or sexual abstinence) or their
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female partner(s) of childbearing potential who are unwilling to use a highly
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effective method of contraception during treatment (and chemotherapy) and for an
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additional 6 months after treatment (and chemotherapy) discontinuation
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If the male's sole partner is of non-childbearing potential, he is not required to
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use additional forms of contraception during the study
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Subject likely to not be available to complete all protocol-required study visits or
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procedures, and/or to comply with all required study procedures (eg, COAs) to the best
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of the subject and investigator's knowledge
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History or evidence of any other clinically significant disorder, condition or disease
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(with the exception of those outlined above) that, in the opinion of the investigator
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or Amgen physician, if consulted, would pose a risk to subject safety or interfere
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with the study evaluation, procedures or completion
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Male subjects with a pregnant partner who are unwilling to practice abstinence or use
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a condom during treatment (and chemotherapy) and for an additional period of 6 months
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after treatment (and chemotherapy) discontinuation
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Male subjects unwilling to abstain from donating sperm during treatment (and
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chemotherapy) and for an additional 6 months after treatment (and chemotherapy)
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discontinuation
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