NCT02182141已完成1 期
An Open Label Dose Escalation Study of BIBF 1120 Administered Orally for Four Weeks in Patients With Relapsed or Refractory Multiple Myeloma With Repeated Administration in Patients With Clinical Benefit
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics
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
- •Patients with confirmed diagnosis of multiple myeloma, who did not respond to or relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy and who are currently not eligible for transplant modalities.
- •Age 18 years or older
- •Life expectancy of at least six months
- •Patients have to give written informed consent (which must be consistent with ICH-GCP and local legislation)
- •Eastern Cooperative Oncology Group (ECOG) performance score <
- •Recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies.
排除标准
- •History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, fractures or injuries with incomplete healing
- •Active infectious disease
- •Uncontrolled, severe hypertension
- •Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
- •Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
- •Absolute neutrophil count less than 1000 / mm³.
- •Platelet count less than 30 000 / mm³
- •Conjugated Bilirubin greater than 2 mg / dl (> 34 μmol/L, SI unit equivalent)
- •Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal
- •Endogenous creatinine clearance (ECC) <20 ml/min
- •Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
- •Pregnancy or breastfeeding
- •Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
- •Patients unable to comply with the protocol
- •Active alcohol or drug abuse
研究组 & 干预措施
BIBF 1120
Experimental
干预措施: BIBF 1120 ES (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Up to 11 months
次要结局
- Change from baseline in laboratory parameters(Baseline, up to 11 months)
- Concentration at 2h (C2,1)(2 hours after first administration)
- Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score(Baseline, up to 11 months)
- Predose concentration immediately before administration of the Nth dose over the dosing interval τ (Cpre,N)(Up to day 28)
- Time to reach minimum plasma concentration during the dosing interval τ at steady state (tmin,ss)(Up to 11 months)
- Time to reach maximum plasma concentration during the dosing interval τ at steady state (tmax,ss)(Up to 11 months)
- Terminal half-life at steady state (t1/2,ss)(Up to 11 months)
- Apparent plasma clearance at steady state (CL/F,ss)(Up to 11 months)
- Mean residence time at steady state (MRTpo,ss)(Up to 11 months)
- Objective tumor response in surrogate markers(Baseline, up to 11 month)
- Change from baseline in electrocardiogram (ECG)(Baseline, up to 11 months)
- Change from baseline in cellular protein tyrosine kinase inhibition(Baseline, up to 11 months)
- Area under the plasma concentration-time curve during the dosing interval τ (24 h) at steady state (AUCτ,ss)(Up to 11 months)
- Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss)(Up to 11 months)
- Minimum plasma concentration during the dosing interval τ at steady state (Cmin,ss)(Up to 11 months)
- Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120(Up to 11 months)
- Change in vital signs(up to 11 months)
- Maximum plasma concentration during the dosing interval τ at steady state (Cmax,ss)(Up to 11 months)
- Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)(Up to 11 months)
- Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria(Up to 11 months)
研究者
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