STUDY OF ROMIPLOSTIM FOR CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA IN ADULT SUBJECTS WITH NON-SMALL CELL LUNG CANCER (NSCLC), OVARIAN CANCER, OR BREAST CANCER

Not Applicable

Recruiting

Conditions: -D695 Secondary thrombocytopenia
Secondary thrombocytopenia
D695

Registration Number: PER-032-19

Lead Sponsor: AMGEN INC.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 0

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 ≥ 18 years of age at signing of the informed consent.
-Documented active stage III or IV locally advanced or metastatic NSCLC, breast cancer, or ovarian cancer, or any stage recurrent disease.
oPatients 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, 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 < 75 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

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.
-Neo-adjuvant chemotherapy or adjuvant chemotherapy, which is offered as part of a multimodality treatment with surgery or definitive radiation.
-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 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 ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding acute lymphoblastic leukemia and multiple myeloma).
-Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).