NCT00272415终止1 期
A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 39
- 主要终点
- Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ
研究概览
简要总结
This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible
- •Measurable indicator metastases
- •Age 18 years or older
- •ECOG status 0-2
- •An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea
- •Hematocrit > 29%, ANC > 1500 cells/ul, platelets > 100,000 cells/ul
- •Serum creatinine within the laboratory's upper limit of normal
- •Serum AST and ALT ≤ 1.5 x the laboratory's upper limit of normal
- •Subject signed informed consent prior to subject entry
排除标准
- •Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen.
- •Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment.
- •Subjects previously treated with DTIC or TMZ
- •Symptomatic central nervous metastases
- •Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.
- •Confirmed diagnosis of hepatitis or HIV infection
- •Any medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial
- •Patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy
- •Patients unwilling to comply with the protocol or who in the judgment of the Principal Investigator are unable to abide by the rules of the protocol
- •Subjects who have received a potent CYP3A4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment
- •Subjects who have received amiodarone within 30 days of study drug administration
- •History of hypersensitivity reaction to more than three (3) drugs or to mannitol
- •Patients who have received any investigational study agent within 30 days of Day 1 of Cycle 1
研究组 & 干预措施
1
Experimental
干预措施: INO-1001 (Drug)
1
Experimental
干预措施: temozolomide (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ
时间窗: Length of study
Pharmacokinetic (PK) profile of intravenous INO-1001
时间窗: Length of study
Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001
时间窗: Length of study
次要结局
- Safety of repeat dosing(Length of study)
- Pharmacodynamic (PD) activity of intravenous INO-1001(Length of study)
- Response(Length of study)
- Progression-free survival(Length of study)
- Overall survival(Length of study)
研究者
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