Dose-escalating, Pilot Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ALS-357 Topically Administered to Patients With Cutaneous Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma.
研究概览
简要总结
A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Participants must be 18 years or older.
- •Study Participants must have 2 sites of cutaneous metastatic melanoma that can not be removed with surgery.
- •Study Participants may have been previously treated with chemotherapy or immunotherapy but not with in 4 weeks of first dose of study treatment.
排除标准
- 未提供
研究组 & 干预措施
1
ALS-357 applied topically twice weekly for four weeks.
干预措施: ALS-357 (Drug)
2
ALS-357 applied topically every other day for four weeks.
干预措施: ALS-357 (Drug)
3
ALS-357 applied topically once daily for four weeks.
干预措施: ALS-357 (Drug)
4
ALS-357 applied topically twice daily for four weeks.
干预措施: ALS-357 (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma.
时间窗: Day 8, 15, 22, 29 and 43
Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
时间窗: Day 8, 15, 22, 29 and 43
次要结局
- Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay.(Day 15, 29 and 43)
- Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways.(Day 15, 29 and 43)
- Evaluate the plasma concentration of ALS-357 at each scheduled study visit.(Day 1, 8, 15, 22, 29 and 43)