NCT02610361已完成1 期
A Phase 1A/1B, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Preliminary Antitumor Activities of the B RAF Inhibitor BGB 283 in Subjects With Solid Tumors
BeiGene19 个研究点 分布在 2 个国家目标入组 131 人开始时间: 2013年11月20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
- 131
- 试验地点
- 19
- 主要终点
- Objective response rate based on RECIST Version 1.1 in subjects with selected tumor types in phase 1b
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-283 in patients with solid tumours.
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
- •Provided written informed consent prior to enrollment.
- •Male or female and at least 18 years of age.
- •A life expectancy of at least 12 weeks.
- •Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standard therapy is available.
- •One of B-RAF, N-RAS, or K-RAS mutation positive solid tumor.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Able to swallow and retain oral medication.
- •Adequate bone marrow, liver, and renal function:
- •Hemoglobin > 9 g/dL
- •Absolute neutrophil count ≥ 1000/mm^3
- •Platelets ≥ 100,000/mm^3
- •Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with known liver metastasis)
- •Creatinine clearance ≥ 45 mL/min (calculated by the Cockcroft Gault formula).
- •Female subjects are eligible to enter and participate in the study if they are of:
- •a) Non childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who
- •i) Has had a hysterectomy,
- •ii) Has had a bilateral oophorectomy (ovariectomy),
- •iii) Has had a bilateral tubal ligation, or
- •iv) Is post menopausal (total cessation of menses for ≥ 1 year).
- •b) Childbearing potential, has a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), and uses adequate contraception before study entry and throughout the study until 28 days after the last investigational product administration. Adequate contraception, when used consistently and in accordance with both the product label and the instructions of the physician, are defined as follows:
- •i) Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
- •ii) Any intrauterine device with a documented failure rate of less than 1% per year.
- •iii) Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR diaphragm with spermicide; OR male condom and diaphragm.
- •Subjects with treated brain metastasis are eligible to enter and participate in the study if they are neurologically stable.
排除标准
- •Female subjects who are pregnant or lactating.
- •Subjects receiving cancer therapy (chemotherapy or other systemic anti cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment.
- •Any major surgery within 28 days prior to enrollment.
- •Any radiotherapy within 14 days prior to enrollment, providing the subject has recovered from all toxicities to NCI-CTCAE ≤ Grade
- •Use of any investigational anti cancer drug within 28 days before the first investigational product administration.
- •Unresolved toxicity > Grade 1 (according to NCI-CTCAE, Version 4.03) from previous anti cancer therapy, unless agreed by the sponsor.
- •History or presence of gastrointestinal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or to any component of BGB-
- •(To date there are no known Food and Drug Administration [FDA] approved drugs chemically related to BGB-283).
- •Untreated leptomeningeal or brain metastasis. Subjects with previously treated brain metastasis that are asymptomatic, off steroids for longer than 28 days are permitted.
- •Any unstable, pre-existing major medical condition that in the opinion of the Investigator contra indicates the use of an investigational product, including active infection, known human immunodeficiency virus (HIV) positive subjects, or known Hepatitis B or C.
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •As a result of the medical interview, physical examination or screening investigations, the investigator considers the subject unfit for study.
- •Is on medication listed in the protocol or requires any of these medications during treatment with BGB-
- •Candidates for curative therapy.
- •Unable or unwilling to comply with the required treatment.
研究组 & 干预措施
BGB-283
Experimental
干预措施: BGB-283 (Drug)
结局指标
主要结局
Objective response rate based on RECIST Version 1.1 in subjects with selected tumor types in phase 1b
时间窗: From the first administration of the investigational product to the end of the study treatment, within 1 year in average
Number of participants with adverse events in phase 1a
时间窗: From first dose to within 28 days of last dose of BGB-283, within 1 years in average
次要结局
- Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast) in phase 1a(During first 2 weeks)
- Area under the plasma concentration-time curve from time 0 to infinity time in (AUC∞) in phase 1a(During first 2 weeks)
- Maximum plasma concentration (Cmax) in phase 1a(During first 2 weeks)
- Time to reach maximum plasma concentration (tmax) in phase 1a(During first 2 weeks)
- Terminal elimination half-life (t1/2) in phase 1a(During first 2 weeks)
- Tumor response in phase 1a(Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, within 1 year in average)
- Number of participants with adverse events in phase 1b(From first dose to within 28 days of last dose of BGB-283, within 1 year in average)
- Progression-free survival (PFS)(The interval from study treatment initiation until the determination of disease progression or death, within 1 year in average)
研究者
研究点 (19)
Loading locations...
相似试验
已完成
1 期
A Study of CS1003 in Subjects With Advanced Solid TumorsAdvanced CancerNCT03475251CStone Pharmaceuticals108
已完成
1 期
Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced TumorsAdvanced CancerNCT02407990BeiGene451
进行中（未招募）
1 期
A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid LeukemiasNCT06226571Syndax Pharmaceuticals76
已完成
1 期
A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid TumorsNeoplasms MalignantNCT04047290Akesobio Australia Pty Ltd80
已完成
1 期
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid TumorsSolid TumorsNCT04774952Revolution Medicines, Inc.58