A Study of Olaratumab (IMC-3G3) in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Olaratumab; Mitoxantrone; Prednisone
Intervention description: 15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8; 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); 5 mg orally (PO) twice daily (BID) on each day
Intervention MeSH terms: Prednisone; Mitoxantrone; Olaratumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

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 prostate cancer following disease progression or intolerance on
      docetaxel-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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