NCT01345214终止1 期
An Open-label, Multiple-Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
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
- 17
- 试验地点
- 14
- 主要终点
- Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 across multiple doses in patients with solid tumors and chemotherapy induced thrombocytopenia (CIT) scheduled to receive at least two cycles of myelosuppressive chemotherapy on Day 1 every 21 days at the same dosages and schedule in the study. The secondary objectives are to characterize the PK profiles of ONO-7746 and to explore the pharmacodynamic effect of ONO-7746 on CIT.
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
- •Signed written informed consent
- •Age ≥ 18 years
- •Patients with confirmed solid tumor and scheduled to receive at least two cycles of myelosuppressive chemotherapy on Day 1 every 21 days at the same dosage and schedule in the study.
- •Experienced thrombocytopenia as evidenced by a platelet count < 100 Gi/L in the preceding cycle immediately before study enrollment.
- •ECOG performance status ≤ 2
- •For females, surgically sterilized, postmenopausal or agree to use an acceptable form of birth control
- •Patients treated with novel anticancer agents (e.g. bevacizumab, erlotinib, trastuzumab, cetuximab) may be allowed if it is considered the standard treatment by the investigator and after consultation and approval from the Sponsor
- •PT/INR and aPTT are within 80% to 120% of the normal range
排除标准
- •Experienced thrombocytopenia as evidenced by a platelet count < 25 Gi/L at any time in the preceding cycle immediately before enrollment into the study
- •History or presence of clinically significant disease
- •Received any TRAs, or rHuIL-11 within the last 4 weeks prior to screening
- •Had received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening).
- •Pregnant, wanting to become pregnant or lactating
研究组 & 干预措施
E
Experimental
干预措施: ONO-7746 (Drug)
结局指标
主要结局
Safety and tolerability of ONO-7746 across ascending multiple doses using vital signs, physical examinations, ECGs, ECOG performance status, CT/MRI, laboratory tests
时间窗: up to four 21-day cycles (up to 84 days)
次要结局
- Characterization of PK profiles on ONO-7746 and exploration of the PD effect of ONO-7746, including changes in platelet counts and any potential effects on ECGs(up to four 21-day cycles (up to 84 days))
研究者
研究点 (14)
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