Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2010-10-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Olaratumab + Mitoxantrone
1 cycle = 3 weeks (21 days)
Olaratumab
15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8
Mitoxantrone
Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1
Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)
Prednisone
5 mg orally (PO) twice daily (BID) on each day
Mitoxantrone: Optional Olaratumab Monotherapy
1 cycle = 3 weeks (21 days)
Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment.
Mitoxantrone
Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1
Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)
Prednisone
5 mg orally (PO) twice daily (BID) on each day
Interventions
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Olaratumab
15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8
Mitoxantrone
Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1
Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)
Prednisone
5 mg orally (PO) twice daily (BID) on each day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
MALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Charleroi, , Belgium
ImClone Investigational Site
Edegem, , Belgium
ImClone Investigational Site
Liège, , Belgium
ImClone Investigational Site
Olomouc, , Czechia
ImClone Investigational Site
Prague, , Czechia
ImClone Investigational Site
Prague, , Czechia
ImClone Investigational Site
Aachen, , Germany
ImClone Investigational Site
Augsburg, , Germany
ImClone Investigational Site
Bonn, , Germany
ImClone Investigational Site
Dresden, , Germany
ImClone Investigational Site
Essen, , Germany
ImClone Investigational Site
Frankfurt, , Germany
ImClone Investigational Site
Freiburg im Breisgau, , Germany
ImClone Investigational Site
Mainz, , Germany
ImClone Investigational Site
Mannheim, , Germany
ImClone Investigational Site
Münster, , Germany
ImClone Investigational Site
Rostock, , Germany
ImClone Investigational Site
Budapest, , Hungary
ImClone Investigational Site
Debrecen, , Hungary
ImClone Investigational Site
Kecskemét, , Hungary
ImClone Investigational Site
Miskolc, , Hungary
ImClone Investigational Site
Nyíregyháza, , Hungary
ImClone Investigational Site
Pécs, , Hungary
ImClone Investigational Site
Szeged, , Hungary
ImClone Investigational Site
Meldola, , Italy
ImClone Investigational Site
Milan, , Italy
ImClone Investigational Site
Roma, , Italy
ImClone Investigational Site
Rozzano, , Italy
ImClone Investigational Site
Trento, , Italy
ImClone Investigational Site
Krakow, , Poland
ImClone Investigational Site
Lublin, , Poland
ImClone Investigational Site
Poznan, , Poland
ImClone Investigational Site
Warsaw, , Poland
ImClone Investigational Site
Barcelona, , Spain
ImClone Investigational Site
Barcelona, , Spain
ImClone Investigational Site
Madrid, , Spain
ImClone Investigational Site
Palma de Mallorca, , Spain
ImClone Investigational Site
Pamplona - Navarra, , Spain
ImClone Investigational Site
Sabadell - Barcelona, , Spain
ImClone Investigational Site
Valencia, , Spain
Countries
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Other Identifiers
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I5B-IE-JGDD
Identifier Type: OTHER
Identifier Source: secondary_id
CP15-0805
Identifier Type: OTHER
Identifier Source: secondary_id
2009-018015-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13938
Identifier Type: -
Identifier Source: org_study_id
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