NCT01062620已完成1 期
A Dose Escalating Phase Ia-b Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer: A Prospective, Single Armed, Open Label, Dose-finding Phase Ia-b Study
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
- Axelar AB
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To define and confirm recommended Phase 2 dose
研究概览
简要总结
A dose escalating phase Ia-b clinical trial of the IGF-1 receptor inhibitor AXL1717 in patients with advanced cancer.
The objective is to study the safety and pharmacokinetics of AXL1717 and to define an appropriate Phase 2 dose for further studies. This is the first study in man. The study is not designed to show tumor response.
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
- •At least 18 years of age.
- •Histologically confirmed diagnosis of advanced solid or haematological malignancy not amenable to standard treatment.
- •Pharmacological treatment attempt justified
- •Preserved major organ functions, i.e:
- •B-Leukocyte count ≥ 3.0 x 109/L
- •B-Neutrophil count ≥ 1.5 x 109/L
- •B-Platelet count ≥ 75 x109/L
- •B-Haemoglobin ≥ 100 g/L (transfusions are allowed)
- •P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the "normal" (i.e. reference) range
- •P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the "normal" range, ≤5 times if liver metastases have been documented
- •P-Creatinine ≤ 1.5 times upper institutional limit of the "normal" range
- •Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
- •Signed written informed consent.
排除标准
- •Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient
- •Known malignancy in CNS
- •Prior anti-tumour therapy within 4 weeks from enrolment (6 weeks for nitrosurea and MitC).
- •Pregnancy or lactation
- •Current participation in any other interventional clinical trial
- •Performance status > ECOG 2 after optimization of analgesics
- •Life expectancy less than 3 months
- •Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
- •Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
研究组 & 干预措施
AXL1717
Experimental
干预措施: AXL1717 (Drug)
结局指标
主要结局
To define and confirm recommended Phase 2 dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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