A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy
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 ng/mL
- has had disease progression or intolerance on docetaxel-based therapy
- PSA ≥ 10 ng/mL
- all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy
or hormonal therapy have resolved to ≤ Grade 1, based on NCI CTCAE v 4.02
- patient has an 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 patient has received more than 1 prior cytotoxic chemotherapy regimen for
metastatic disease
- prior therapy with mitoxantrone for advanced prostate cancer
- The patient 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 PDGF or
platelet-derived growth factor receptors
- known allergy to any of the treatment components: IMC 3G3, mitoxantrone, and/or
prednisone
- radiotherapy within 21 days prior to first dose of IMC-3G3
- any investigational therapy within 30 days of randomization
- is receiving corticosteroids at a dose > 5 mg prednisone orally (PO) 2 times per day
(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