A Phase IIB Clinical Trial of the Anti-Angiogenic Drug Combination Hamsa-1™ in Metastatic Castration Resistant Prostate Cancer (CRPC)
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Progression free survival (PFS) measured 24 weeks after treatment initiation
研究概览
简要总结
Hamsa-1™ is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Hamsa-1™ comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety.The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase IIb clinical trial aims to evaluate the efficacy of Hamsa-1™ for the treatment of metastatic Castration Resistant Prostate Cancer (CRPC) patients.
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
- •Subjects willing and able to give written informed consent
- •Confirmed metastatic castration resistant prostate cancer and rising PSA
- •ECOG performance status ≤ 1
- •Adequate renal function, hepatic function and bone marrow reserve.
- •Subjects capable of swallowing.
排除标准
- •Hypersensitivity to one or more of the Hamsa-1™ active components
- •Glucose-6-phosphate-dehydrogenase deficiency (G6PD)
- •Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
- •Subjects who received any investigational medication, antineoplastic therapy, or any significant change in treatment within 1 month prior to screening
- •Subjects with visceral metastases (e.g. liver, lung)
- •Subjects who received more than 2 prior chemotherapies for the treatment of prostate cancer
- •Subjects suffering from circumstances likely to interfere with absorption of orally administrated drugs
- •Subjects unwilling to or unable to comply with study protocol
研究组 & 干预措施
Hamsa-1™ TL-118
Once daily Hamsa-1™ TL-118 (single arm)
干预措施: Hamsa-1™ TL-118 (Drug)
结局指标
主要结局
Progression free survival (PFS) measured 24 weeks after treatment initiation
时间窗: 24 weeks and up to 3 years
次要结局
- Overall Survival, Time to PSA Progression, PSA Response, Pain Response measured in evaluable patients.(52 weeks and up to 3 years)
- Safety and tolerability(Throughout study)