NCT00716794已完成1 期
A Phase I/II, Open-Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Activity of HE3235 When Administered Orally to Patients With Prostate Cancer
Harbor Therapeutics8 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2008年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- To assess potential activity of HE3235 in prostate cancer patients.
研究概览
简要总结
This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to patients with advanced prostate cancer who have failed hormone therapy and at least one taxane based chemotherapy regimen.
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
- •Main Inclusion Criteria:
- •Patient is male and at least 18 years of age, at the time of screening;
- •Patient has metastatic disease (any T, any N, M1);
- •Patient has failed at least 1 taxane regimen; or Patient has symptomatic or asymptomatic CRPC and is chemotherapy-naïve
- •Patient has histologically or cytologically confirmed adenocarcinoma of the prostate;
- •Patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:
- •PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.
- •Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria;
- •Progression of metastatic bone disease on bone scan with > 2 new lesions
- •Patient has ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;
排除标准
- •Patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation Treated epidural disease is allowed
- •Patient has active infection;
- •Patient having a history of clinically significant cardiovascular disease (such as CHF), clinically significant hepatic, respiratory or renal abnormalities;
- •Patient who has any clinically significant abnormalities in laboratory results at screening
- •Patient who has a history of clinically significant neurological or psychiatric condition;
- •Additional criteria are applicable to expansion cohorts.
结局指标
主要结局
To assess potential activity of HE3235 in prostate cancer patients.
时间窗: Treatment period and post-study follow-up period
To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles.
时间窗: Treatment period
To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing.
时间窗: Treatment period
次要结局
- Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment(Treatment period)
- Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response.(Treament period and post-study follow-up)
研究者
研究点 (8)
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