A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)

Novartis Pharmaceuticals5 个研究点分布在 1 个国家目标入组 108 人开始时间: 2006年5月最近更新: 2010年4月8日

适应症

试验速览

阶段: 1 期
状态: 终止
发起方: Novartis Pharmaceuticals
入组人数: 108
试验地点: 5
主要终点: To determine the maximum tolerated dose

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.

研究设计

研究类型: Interventional
分配方式: Non Randomized
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

•Patients with hormone refractory prostate cancer
•Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.
•Patients must meet laboratory inclusion criteria defined in the protocol
•Patients must be able to provide written informed consent

排除标准

•Patients with prior or concurrent brain metastases
•Impaired cardiac, gastrointestinal, kidney or liver function
•Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

To determine the maximum tolerated dose

次要结局

Safety
Tolerability
Biologic activity
Pharmacokinetic profile

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

研究点 (5)

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