A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 11
- 主要终点
- Determine the maximally tolerated dose of imexon plus DTIC
研究概览
简要总结
AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant melanoma; inoperable stage III or IV disease.
- •Able to perform the activities of daily living.
- •A projected life expectancy of at least 4 months.
- •If female, neither pregnant nor nursing.
- •Willing to use contraceptives to prevent pregnancy.
- •Blood cell counts and blood chemistries in or near normal range.
- •Prior radiation is permitted.
- •No other serious illnesses.
- •No other active malignancy.
- •No serious infections.
- •No other current drug therapy for the cancer or steroid therapy.
排除标准
- •No prior chemotherapy for the stage III or IV disease.
- •Brain metastases
研究组 & 干预措施
imexon + DTIC
干预措施: imexon (Drug)
imexon + DTIC
干预措施: DTIC (Drug)
结局指标
主要结局
Determine the maximally tolerated dose of imexon plus DTIC
determine the toxicity and tolerability of the combination
determine response rate and progression free survival
次要结局
- Determine effects of the drug combination on plasma thiol levels and other biomarkers