EUCTR2008-004355-30-CZ进行中（未招募）不适用
A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination withMitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Disease-related
- •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
- •Demographic
- •Men = 18 years of age
- •Castrate levels of serum testosterone (< 50 ng/dL)
- •PSA = 2 ng/mL
- •Hemoglobin = 9 g/dL (can be post-transfusion)
- •Absolute neutrophil count = 1.5 x 109/L
- •Platelet count = 100 x 109/L (without transfusion within 14 days before enrollment or randomization)
- •Creatinine = 2X ULN
- •Aspartate aminotransferase (AST) and alanine amino transferase (ALT) = 3.0 x ULN
- •Total bilirubin = 1.5x ULN
- •Partial thromboplastin time (PTT) = 1.5 x ULN and international normalized ratio (INR) = ULN.
- •Medications
- •For patients without a history of surgical castration, continued GnRH analog administration is required to maintain castrate levels of testosterone
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease-related
- •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. Patients 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
- •Medications
- •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
- •for the use of low dose coumarin-type anticoagulants (= 2 mg PO QD) or low molecular weight heparins for prophylaxis against central venous catheter thrombosis
- •Major surgical procedure = 30 days before enrollment or not yet recovered from prior major surgery
- •Minor surgery =14 days before enrollment or not yet recovered from prior minor surgery; central venous catheter placement is allowed at any time prior to enrollment provided that patient has recovered and any surgical wound has healed
- •Any prior or synchronous malignancy (except for non-melanomatous skin cancer or lentigo maligna) other than the study disease, unless treated with curative intent with no evidence of disease = 3 years before enrollment
- •Presence of peripheral neuropathy > Grade 1
- •Presence of peripheral edema > Grade 2
- •Known proteinuria > 1 gram/day (subjects with >2+ protein on screening urinalysis require a quantitative evaluation of urine protein)
- •Any clinically significant medical condition other than cancer, including cardiovascular disease or COPD, which in the opinion of the investigator would interfere with the safe delivery of study treatment or increase risk of toxicity
- •History of any medical condition that in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results
- •Known positive test for HIV, hepatitis C, chronic or active hepatitis B
- •Serious or non-healing wound
- •Unable to begin protocol specified treatment within 7 days after enrollment
- •Other investigational procedures are excluded.
- •Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s).
- •Treated previously with c-Met or HGF targeted therapy
- •Subject is not using adequate contraceptive precautions.
- •Subject has known sensitivity to any of the products to be administered during dosing.
- •Subject will not be available for follow-up assessment.
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
研究者
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