NCT01435096已完成1 期
A Phase I Dose Finding Study of BN80927 Administered as an Intravenous Infusion Once Every 3 Weeks in Patients With Advanced Malignant Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Recommended dose determined by incidence of dose limiting toxicity.
研究概览
简要总结
The purpose of this study was to determine the maximum tolerated dose and the recommended dose of BN80927 in patients with advanced malignant solid tumors.
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
- •All included patients:
- •Gave their written (personally signed and dated) informed consent
- •had histologically or cytologically documented malignant solid tumour
- •had received no more than three prior chemotherapy regimens
- •had failed the standard therapy or had no option of an active standard therapy
- •had an estimated survival time of greater than 3 months (according to the investigator's assessment)
- •had a World Health Organisation (WHO) performance status score ≤1
- •were free from other serious concurrent disease
- •had adequate bone marrow function
- •had adequate liver function
- •had adequate renal function
- •who were female and of child-bearing potential must have had a negative result in a pre-study pregnancy test β-human-chorionic-gonadotrophin (β-HCG).
排除标准
- •No patient included:
- •was pregnant or lactating
- •was unable and/or unwilling to comply fully with the protocol and the study instructions;
- •presented with any concomitant condition, which could compromise the objectives of the study
- •had received an investigational drug within 30 days prior to study entry or was scheduled to require concurrent treatment with an experimental drug or treatment during the study
- •had received chemotherapy or hormonotherapy within 4 weeks of study entry, or had received chemotherapy with nitrosoureas or mitomycin-C within 6 weeks of study entry
- •had received any extensive palliative or curative radiotherapy (no more than 35% of their active bone marrow) within 2 weeks of study entry, or had not fully recovered from such treatment
- •had previously received a bone marrow transplant (BMT) or peripheral blood progenitor cells (PBPC)
- •had clinical evidence of major organ failure or brain metastases.
研究组 & 干预措施
BN80927
Experimental
干预措施: BN80927 (Drug)
结局指标
主要结局
Recommended dose determined by incidence of dose limiting toxicity.
时间窗: During cycle 1, up to 3 weeks
Maximum tolerated dose determined by incidence of dose limiting toxicity.
时间窗: During cycle 1, up to 3 weeks
次要结局
- Number of adverse events(Monitored weekly at all treatment cycles and the end of study visit. Maximum 10 treatment cycles, up to 30 weeks.)
- Cmax(72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days))
- Area Under Curve(72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days))
- Tmax(72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days))
- Tumour response assessment according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria.(Baseline, week 3 of cycle 2, then on alternate cycles of treatment (maximum 10 cycles, up to 30 weeks))
- T1/2(72 hours post-dose in treatment cycle 1 and 2 (each cycle is 21 days))
研究者
研究点 (3)
Loading locations...
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