NCT01776307已完成2 期
A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Disease Control Rate
研究概览
简要总结
This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
详细描述
This is an open label, multi-center, Phase 2 study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 colorectal cancer that is metastatic, unresectable, or recurrent.
- •Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin, or irinotecan.
- •Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have colorectal cancer which is K-Ras wild-type.
- •≥ 18 years of age.
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- •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 BBI608 dose.
- •Females of childbearing potential must have a negative serum pregnancy test.
- •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 × upper limit of normal(ULN), or ≤ 2.5 × ULN with metastatic liver disease.
- •Hemoglobin (Hgb) ≥ 10 g/dl.
- •Total bilirubin ≤ 1.5 × ULN.
- •Creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
- •Absolute neutrophil count ≥ 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 BBI
- •Surgery within 4 weeks prior to first dose.
- •Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases 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 and small intestine resection)
- •Unable or unwilling to swallow BBI608 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
BBI608 in combination with panitumumab
Experimental
干预措施: Panitumumab (Drug)
BBI608 in combination with cetuximab
Experimental
干预措施: BBI608 (Drug)
BBI608 in combination with cetuximab
Experimental
干预措施: Cetuximab (Drug)
BBI608 in combination with panitumumab
Experimental
干预措施: BBI608 (Drug)
BBI608 in combination with capecitabine
Experimental
干预措施: BBI608 (Drug)
BBI608 in combination with capecitabine
Experimental
干预措施: Capecitabine (Drug)
结局指标
主要结局
Disease Control Rate
时间窗: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine
次要结局
- Progression Free Survival(The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months)
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle(Blood samples drawn on day 5 during the first study cycle)
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle(Blood samples drawn on day 21 during the first study cycle)
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle(Blood samples drawn on day 21 during the first study cycle)
- Overall Survival(4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months.)
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle(Blood samples drawn on day 5 during the first study cycle)
- Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle(Blood samples drawn on day 21 during the first study cycle)
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle(Blood samples drawn on day 5 during the first study cycle)
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle(Blood samples drawn on day 21 during the first study cycle)
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle(Blood samples drawn on day 21 during the first study cycle)
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle(Blood samples drawn on day 5 during the first study cycle)
- Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle(Blood samples drawn on day 21 during the first study cycle)
- Pharmacodynamics(During the first 28 days of the study cycle)
- Number of Patients With Adverse Events and Serious Adverse Events(The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.)
研究者
研究点 (11)
Loading locations...
相似试验
已完成
1 期
A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic MalignanciesHematologic MalignancyNCT02352558Sumitomo Pharma America, Inc.15
已完成
1 期
A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal CancerAdvanced Gastrointestinal CancerNCT02024607Sumitomo Pharma America, Inc.495
已完成
1 期
A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced CancersCancerNCT02467361Sumitomo Pharma America, Inc.104
已完成
1 期
A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural MesotheliomaNon-Small Cell Lung CancerMalignant Pleural MesotheliomaNCT02347917Sumitomo Pharma Co., Ltd.28
已完成
1 期
A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular CarcinomaHepatocellular CarcinomaNCT02279719Sumitomo Pharma America, Inc.97