A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
研究概览
简要总结
Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.
详细描述
GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic melanoma
- •Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
- •Normal organ and marrow function
- •Willing to submit to blood sampling for planned PK/PD analyses
- •Ability of understand and willingness to sign a written informed consent
排除标准
- •No other investigational or commercial agents or therapies
- •Prior exposure to GMX1777, GMX1778 or CHS828
- •Patients with uncontrolled, intercurrent illness
- •Pregnant or breastfeeding women
研究组 & 干预措施
1
40 mg/m2 GMX1777 with Temozolomide
干预措施: Temozolomide (Drug)
6
125 mg/m2 GMX1777 with Temozolomide
干预措施: Temozolomide (Drug)
1
40 mg/m2 GMX1777 with Temozolomide
干预措施: Obatoclax Mesylate (Drug)
2
50 mg/m2 GMX1777 with Temozolomide
干预措施: Obatoclax Mesylate (Drug)
2
50 mg/m2 GMX1777 with Temozolomide
干预措施: Temozolomide (Drug)
3
62 mg/m2 GMX1777 with Temozolomide
干预措施: Obatoclax Mesylate (Drug)
3
62 mg/m2 GMX1777 with Temozolomide
干预措施: Temozolomide (Drug)
4
80 mg/m2 GMX1777 with Temozolomide
干预措施: Obatoclax Mesylate (Drug)
4
80 mg/m2 GMX1777 with Temozolomide
干预措施: Temozolomide (Drug)
5
100 mg/m2 GMX1777 with Temozolomide
干预措施: Obatoclax Mesylate (Drug)
5
100 mg/m2 GMX1777 with Temozolomide
干预措施: Temozolomide (Drug)
6
125 mg/m2 GMX1777 with Temozolomide
干预措施: Obatoclax Mesylate (Drug)
结局指标
主要结局
Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
时间窗: 2 years
Learn more about the side effects of taking GMX1777 in combination with temozolomide
时间窗: Within the first 4 weeks
Determine the disease response to treatment with GMX1777 in combination with temozolomide
时间窗: Within the first 8 weeks
次要结局
- Learn more about how the body processes GMX1777(Within the fisrt 30 days)