A Randomized Phase 2 Study of Human Anti-PDGFRa Monoclonal Antibody IMC-3G3 plus Mitoxantrone plus Prednisone or Mitoxantrone plus Prednisone in Metastatic Castration-Refractory Prostate Cancer (CRPC) Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy.

ImClone LLC0 个研究点目标入组 120 人开始时间: 2010年5月14日最近更新: 2013年12月23日

试验速览

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•- Histologically-confirmed adenocarcinoma of the prostate
•- castration resistant
•- progression after or toxicity of docetaxel
•- adequate hematologic, hepatic and renal function
•- life expectancy > 3 months
•- the patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•- more than 1 cytotoxic chemotherapy regimen for metastatic disease
•- prior therapy with mitoxantrone for prostate cancer
•- history of prior treatment with agents directly inhibiting PDGF[R]
•- radiotherapy = 21 days prior to first dose of IMC-3G3
•- any investigational therapy within 30 days of randomization
•- prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radio nucleotide therapy and has either ongoing evidence of bone marrow dysfunction or bone pain that is poorly controlled in the opinion of the investigator
•- ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding, other serious uncontrolled medical disorders
•- known or suspected brain or leptomeningeal metastases

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