NCT01215799已完成2 期
A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer
CytRx1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a Phase II open-label study evaluating the preliminary efficacy and safety of bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory Prostate Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males age ≥18 years.
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- •Hormone-refractory prostate cancer having progressed despite androgen deprivation therapy that resulted in a castrated level of testosterone (<50 ng/dL) or orchiectomy; with or without evidence of measurable or evaluable disease.
- •PSA increase defined as 2 consecutive rises; first increase in PSA occurred a minimum of 1 week from the reference value; increase in PSA should be at least 25% above the reference value and absolute PSA value should be >5 ng/mL.
- •May have received no more than 1 prior chemotherapy regimen. Prior immunomodulatory therapy (sipuleucel-t (Provenge), interferon) is allowed.
- •Must be taking a single agent LHRH agonist or antagonist, unless previously underwent orchiectomy.
- •ECOG performance status 0-
- •Able to swallow pills.
- •Able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site.
排除标准
- •Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment
- •Exposure to any investigational agent within 30 days of the Screening Visit.
- •No prior flutamide (Eulexin) and ketoconazole use within 4 weeks, bicalutamide (Casodex) within 6 weeks or nilutamide (Nilandron) within 6 weeks of study enrollment.
- •Use of Quadramet therapy during 2 months prior to study enrollment or Metastron ever.
- •Prior treatment with a tyrosine kinase inhibitor.
- •Subjects who have started bisphosphonate therapy within 4 weeks of study enrollment are excluded. Subjects treated with a stable dose of a bisphosphonate for >4 weeks and the tumor has still progressed can be enrolled in the study.
- •Known CNS disease or CNS metastases.
- •History of other malignancies within the last five years except curatively treated basal cell carcinoma or superficial bladder cancer.
- •Laboratory values: Screening serum creatinine greater than or equal to 1.5 x ULN, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1500/mm3, hematocrit level <35% and platelets <100,000/mm
- •History of abnormal bleeding or use of anticoagulant therapy.
- •Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines.
- •Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- •History of MI within 6 months or uncontrolled angina within 3 months.
- •Severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, chronic renal disease, chronic liver disease.
- •Known HIV infection.
- •Uncontrolled active, infection.
- •Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- •Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.
研究组 & 干预措施
Bafetinib
Experimental
干预措施: Bafetinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: At six months.
The primary objective of this study is to determine the preliminary efficacy of administration of bafetinib in subjects with hormone-refractory prostate cancer (HRPC), as measured by the objective response rate (ORR), which is a combination of CR (PSA ≤0.12 ng/mL) and PR (≥50% reduction in PSA from baseline).
次要结局
- Safety(At six months.)
- Progression-free survival(At six months.)
- Objective tumor response(At six months.)
研究者
研究点 (1)
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