Status:
COMPLETED
A Study of Olaratumab (IMC-3G3) in Prostate Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01204710
Start Date
October 1 2010
End Date
October 1 2013
Last Update
September 20 2019
Active Locations (40)
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1
ImClone Investigational Site
Charleroi, Belgium, 6000
2
ImClone Investigational Site
Edegem, Belgium, 2650
3
ImClone Investigational Site
Liège, Belgium, 4000
4
ImClone Investigational Site
Olomouc, Czechia, 77520