Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer - AMG 102, MP in Subjects with Castrate Resistant Prostate Cancer

Amgen0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

研究概览

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•* Pathologically confirmed adenocarcinoma of the prostate
•* Radiographic evidence of metastatic disease
•* Progressive disease meeting at least one of the following criteria:
•1) a sequence of at least 2 rising PSA values measured at a minimum of 1
•week apart with a 2 ng/mL minimum starting value, or
•2) progression according to RECIST criteria for measurable lesions, or
•3) appearance of 2 or more new lesions on bone scan.
•* History of prior taxane-based chemotherapy for metastatic prostate cancer; no
•more than one prior chemotherapy regimen for CRPC is allowed (estramustine
•will be considered as chemotherapy)
•* ECOG Performance status 0 or 1
•* Life expectancy * 3 months
•* Men * 18 years of age

•* Treatment with external beam radiotherapy * 14 days before enrollment or
•radiopharmaceutical * 8 weeks
•* * 4 weeks since receipt of most recent prior chemotherapy, non-GnRH analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and <6 weeks since receipt of prior bevacizumab.
•* Subjects with evidence of an antiandrogen withdrawal response must demonstrate objective or PSA progression following the response.
•* Known CNS metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area).
•* Significant cardiovascular disease (CHF class III or IV, uncontrolled angina, MI within 6 months of enrollment); patients with medically stable atrial fibrillation may be included.
•* LVEF < 50% by MUGA or ECHO
•* Treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection)
•* Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed

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