NCT01292655已完成1 期
Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-906024 in Subjects With Advanced Solid Tumors
Bristol-Myers Squibb7 个研究点 分布在 2 个国家目标入组 94 人开始时间: 2011年3月3日最近更新:
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
- 入组人数
- 94
- 试验地点
- 7
- 主要终点
- Number of subjects with adverse events as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in subjects with advanced or metastatic solid tumors who no longer respond to or have relapsed from standard therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subjects with advanced or metastatic solid tumors (non-hematologic refractory to or relapsed from standard therapies or for which there is no known effective treatment during dose escalation
- •Subjects with squamous non-small cell lung cancer and triple-negative breast cancer or other solid tumor types for which Notch activation has been demonstrated (such as pancreatic, ovarian and melanoma) during dose expansion
- •Biopsy accessible tumor (may be waived under certain circumstances)
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Adequate organ and bone marrow function
排除标准
- •Infection
- •Elevated triglycerides
- •Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
- •Taking medications known to increase risk of Torsades De Pointes
研究组 & 干预措施
Arm A1 (Escalation): BMS-906024
Experimental
BMS-906024 solution intravenously as specified
干预措施: BMS-906024 (Drug)
Arm A2 (Expansion): BMS-906024
Experimental
BMS-906024 solution intravenously as specified
干预措施: BMS-906024 (Drug)
Arm B1 (Escalation): BMS-906024
Experimental
BMS-906024 solution intravenously as specified
干预措施: BMS-906024 (Drug)
Arm B2 (Expansion): BMS-906024
Experimental
BMS-906024 solution intravenously as specified
干预措施: BMS-906024 (Drug)
结局指标
主要结局
Number of subjects with adverse events as a measure of safety and tolerability
时间窗: Weekly assessments until study discontinuation due to disease progression or unacceptable adverse event as well as an assessment 30 day after treatment discontinuation with an average time on study expected to be <1 year
次要结局
- Tumor assessments using response evaluation criteria in solid tumors (RECIST) v1.1(Tumor assessments at least every 8 weeks during treatment period)
- PD changes from baseline in the expression of Notch pathway-related genes in surrogate tissues (peripheral blood cells) and tumor biopsies(PD changes from baseline during the first 4-5 weeks of dosing)
- PK parameters for BMS-906024 and its metabolite BMS-911557, maximum observed concentration (Cmax)(PK at multiple time points during the first 8 weeks of dosing)
- PK parameters for BMS-906024 and its metabolite BMS-911557, minimum observed concentration (Cmin)(PK at multiple time points during the first 8 weeks of dosing)
- PK parameters for BMS-906024 and its metabolite BMS-911557, time to reach maximum observed concentration (Tmax)(PK at multiple time points during the first 8 weeks of dosing)
- PK parameters for BMS-906024 and its metabolite BMS-911557, terminal phase elimination half-life (T-Half)(PK at multiple time points during the first 8 weeks of dosing)
- PK parameters for BMS-906024 and its metabolite BMS-911557, accumulation index (AI)(PK at multiple time points during the first 8 weeks of dosing)
- PK parameters for BMS-906024 and its metabolite BMS-911557, area under the concentration-time curve (AUC)(PK at multiple time points during the first 8 weeks of dosing)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate the Safety and Tolerability of Weekly Intravenous (IV) Doses of BMS-906024 in Subjects With Acute T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic LymphomaLymphoblastic Leukemia, Acute T-cellPrecursor T-Cell Lymphoblastic LymphomaNCT01363817Bristol-Myers Squibb31
已完成
1 期
Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid TumorsCancerNCT01653470Bristol-Myers Squibb141
终止
1 期
Phase I Ascending Multiple-Dose Study of BMS-986115 in Subjects With Advanced Solid TumorsVarious Advanced CancerNCT01986218Bristol-Myers Squibb36
招募中
1 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.High-grade Serous Ovarian Carcinoma (HGSOC)Uterine Serous Carcinoma (USC)Non-small Cell Lung Cancer (NSCLC)NCT06476808Bristol-Myers Squibb240
终止
1 期
A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid MalignanciesAdvanced Solid MalignanciesNCT00351325Bristol-Myers Squibb45