NCT01781455已完成1 期
A Phase I Clinical Study of BBI503 in Adult Patients With Advanced 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
- 入组人数
- 311
- 试验地点
- 19
- 主要终点
- Number of participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced 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
- •Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
- •A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective.
- •≥ 18 years of age
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- •Karnofsky performance status ≥ 70%
- •Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
- •Females of childbearing potential must have a negative serum pregnancy test
- •Aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 1.5 × upper limit of normal (ULN)
- •Hemoglobin (Hgb) ≥ 10 g/dl
- •Total bilirubin < or equal to 1.5 × ULN
- •Creatinine < or equal to 1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- •Absolute neutrophil count < or equal to 1.5 x 10^9/L
- •Platelets ≥ 100 x 10^9/L
- •Life expectancy ≥ 3 months
排除标准
- •Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503
- •Surgery within 4 weeks prior to first dose
- •Any known untreated brain metastases. Treated subjects must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
- •Pregnant or breastfeeding
- •Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection and small intestinal resection)
- •Unable or unwilling to swallow BBI503 capsules daily
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
BBI503
Experimental
干预措施: BBI503 (Drug)
结局指标
主要结局
Number of participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Adverse events will be assessed at baseline, while the participant is taking BBI503, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months.
Assessment of safety of BBI503 by reporting of adverse events and serious adverse events.
Determination of the recommended Phase 2 dose
时间窗: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks
次要结局
- Anti-tumor activity(Participants will be assessed every eight weeks for anti-tumor activity.)
- Pharmacokinetic profile (Area under the curve) of BBI503(During the first 28 days of treatment)
- Pharmacodynamic activity(During the first 28 days of treatment)
研究者
研究点 (19)
Loading locations...
相似试验
撤回
2 期
A Study of BBI503 in Adult Patients With Advanced Urologic MalignanciesUrologic MalignanciesUrothelial CarcinomaRenal Cell CarcinomaNCT02232646Sumitomo Pharma America, Inc.
已完成
1 期
A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular CarcinomaAdvanced Solid TumorsHepatocellular CarcinomaNCT02354898Sumitomo Pharma Co., Ltd.60
已完成
2 期
A Study of BBI503 in Adult Patients With Advanced Hepatobiliary CancerHepatocellular CarcinomaCholangiocarcinomaNCT02232633Sumitomo Pharma America, Inc.45
终止
2 期
A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal TumorsGastrointestinal Stromal TumorsNCT02232620Sumitomo Pharma America, Inc.2
已完成
1 期
A Study of BBI608 in Adult Patients With Advanced MalignanciesCancer, Advanced MalignanciesNCT01775423Sumitomo Pharma America, Inc.87