Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
histologically-confirmed adenocarcinoma of the prostate
radiographic evidence of metastatic prostate cancer (Stage M1 or D2)
has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of \<50 nanograms per milliliter (ng/mL)
has had disease progression or intolerance on docetaxel-based therapy
prostate-specific antigen (PSA) ≥10 ng/mL
all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to ≤Grade 1, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.02
participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
adequate hematologic function
adequate hepatic function
adequate renal function
urinary protein is ≤1 on dipstick or routine analysis
life expectancy of more than 3 months
fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study
signed Informed Consent Document
You may not be if
concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms
The participant has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease
prior therapy with mitoxantrone for advanced prostate cancer
The participant has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is ≥10% below the lower limit of normal institutional range
history of prior treatment with other agents that directly inhibit platelet-derived growth factor (PDGF) or platelet-derived growth factor receptors (PDGFR)
known allergy to any of the treatment components: olaratumab, mitoxantrone, and/or prednisone
radiotherapy within 21 days prior to first dose of olaratumab
any investigational therapy within 30 days of randomization
is receiving corticosteroids at a dose \>5 mg prednisone PO BID or equivalent
received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
known or suspected brain or leptomeningeal metastases
known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Clareo Health | A Study of Olaratumab (IMC-3G3) in Prostate Cancer
