EUCTR2005-003228-20-GB进行中（未招募）1 期
A PHASE II, MULTI-CENTER, OPEN-LABEL STUDY OF YM155 IN SUBJECTS WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) PREVIOUSLY TREATED WITH AT LEAST ONE PRIOR CHEMOTHERAPY REGIME
Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V by August 2005)0 个研究点目标入组 60 人开始时间: 2005年9月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
入选标准
- •Subjects are eligible for the study if all of the following apply:
- •1) Written informed consent and HIPAA (U.S. sites only) authorization have been
- •2) Male subjects =18 years of age with histologically or cytologically confirmed prostate cancer.
- •3) Subject has a serum testosterone level < 50 ng/dL.
- •4) Subject has been treated with at least 1 prior chemotherapy regimen. For US subjects, the subject had to have at least 1 regimen containing taxotere and prednisone.
- •5) PSA at baseline must be at least 5 ng/mL.
- •6) Subject has evidence of disease progression on hormonal therapy and following at
- •least one course of chemotherapy. Disease progression prior to study entry is defined by any of the following:
- •a. Appearance of at least one new lesion on bone scintigraphy or X-ray as compared
- •to previous evaluations, or
- •b. Appearance of new soft tissue disease or an increase of at least 20% in the sum of the largest diameters of the previously measurable soft tissue disease as
- •documented by appropriate imaging modality, or
- •c. A rising PSA defined as an increase in PSA on 2 consecutive measurements
- •separated by at least 1 week compared to a reference PSA.
- •7) ECOG performance status 0-2.
- •8) Life expectancy greater than 12 weeks.
- •9) Willingness to comply with all procedures and assessments.
- •10) In the case of medical castration, subject is receiving stable dose of LHRH-agonist or LHRH-antagonist.
- •11) Subject must be off anti-androgen therapy at least 4 weeks prior to dosing for
- •flutamide and other secondary hormonal therapy and 6 weeks for nilutaminde and
- •bicalutamide.
- •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
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •1) Radiation therapy within 4 weeks prior to the start of YM155.
- •2) Prior strontium or samarium or other radioisotope therapy within 12 weeks prior to
- •start of YM155.
- •3) Has metastases to the brain.
- •4) Concurrent anticancer therapy (chemotherapy, vaccines, immunotherapy) delivered within the last 4 weeks (6 weeks for nitrosoureas or mitomycin C, or other agents known to cause prolonged marrow suppression) except for continued use without modification of LHRH-agonists, LHRH-antagonists, and bisphosphonates initiated 4 weeks or more before the start of YM155.
- •5) History of other malignancy in the last 5 years.
- •6) Participated in a clinical study involving an investigational drug or device within
- •4 weeks prior to the start of YM155.
- •7) Known history of positive test for hepatitis B surface antigen (HbsAg) or hepatitis C antibody or history of positive test for human immunodeficiency virus (HIV) infection.
- •8) Had major surgery within the past 21 days prior to the start of YM155.
- •9) Uncontrolled intercurrent illness, including but not limited to ongoing or active
- •infection, symptomatic congestive heart failure, unstable angina pectoris, unstable
- •cardiac arrhythmia, seizure disorder, or psychiatric illness/social situations that would
- •limit compliance with study requirements.
- •10) Subjects with a urine protein of 2+ (grade 2) and above prior to start of YM155.
- •11) Has inadequate bone marrow, renal, and hepatic function as evidenced by:
- •a. Absolute neutrophil count (ANC) = 1500/mm3 and platelet count = 100,000/mm3,
- •b. Serum creatinine = 1.5 upper limit of normal (ULN) or calculated creatinine
- •clearance < 60 mL/min at screening,
- •c. Total bilirubin = 1.5 times the upper limit of normal (ULN) National Cancer
- •Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
- •d. Alanine transaminase (ALT) and aspartate transaminase (AST) = 2.5 X ULN (NCI
- •CTCAE Grade 1); if the subject has documented liver metastases and/or hepatoma,
- •ALT and AST = 5 X ULN.
- •12) Any clinical condition, which, in the opinion of the investigator, would not allow safe conduct of the study.
- •13) Use of any alternative medications (e.g. herbal supplements) within 2 weeks prior to the start of study drug.
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