A Phase 1A/1B, Open Label, Multiple Dose, Dose Escalation, and Expansion Study to Investigate the Safety, Pharmacokinetics, Food Effect, and Antitumor Activities of BGB-290 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 7
- 主要终点
- Primary PK 1
研究概览
简要总结
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the Pharmacokinetics (PK) of BGB 290 in participants with advanced solid tumors.
详细描述
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and dose regimen is required prior to determining the next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing Expansion) will investigate efficacy in participants with selected tumor types and further evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB (Food Effect) will investigate the food effect on the PK of BGB 290 in participants with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and at least 18 years of age with a life expectancy of at least 12 weeks.
- •Histologically or cytologically confirmed malignancy that has progressed to the advanced or metastatic stage for which no effective standard therapy is available.
- •BRCA1/2 mutations are not required but enrichment of this participant population is permitted.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Adequate bone marrow, liver, and renal function.
- •Participants who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.
- •Eligible participants who have received the prior chemotherapy regimen in the advanced or metastatic setting.
- •Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and throughout the study until 28 days after the last investigational product administration.
- •Able to swallow and retain oral medication.
排除标准
- •Participants did not receive prior therapies targeting poly-ADP ribose polymerase (PARP).
- •Participants who are not considered to be refractory to platinum-based therapy (e.g., progressive disease at the first tumor assessment while receiving platinum treatment).
- •Participants who have not been treated with chemotherapy, biologic therapy, immunotherapy, or other investigational agent within five times half-lives of the last treatment or within 4 weeks (whichever is longer) prior to starting study drug (or who have not recovered from the side effects of such therapy).
- •Participants who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.
- •Participants must have recovered from the treatment and have a stable clinical condition before entering this study.
- •Participants who have not received therapeutic radiotherapy to target lesions. 7.Participants who have received local palliative radiotherapy of non-target lesions for local symptom control within the last 21 days must have recovered from any adverse effects of radiotherapy before recording screening symptoms. 8.No untreated brain metastasis or unstable neurologic condition after the completion of radiation, or requiring corticosteroid of > 40 mg prednisone daily equivalent dose to control the symptoms.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
ovarian cancer, fallopian cancer, or primary peritoneal cancer
60mg BID oral.
干预措施: BGB-290 (Drug)
Breast Cancer
60mg BID Ora
干预措施: BGB-290 (Drug)
Prostate Cancer
60mg BID Oral
干预措施: BGB-290 (Drug)
Small Cell Lung Cancer
60mg BID Oral
干预措施: BGB-290 (Drug)
Gastric Cancer
60mg BID Oral
干预措施: BGB-290 (Drug)
结局指标
主要结局
Primary PK 1
时间窗: through study completion, an average of 1 year
Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).
Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria
时间窗: through study completion, an average of 1 year
The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.
Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1
时间窗: through study completion, an average of 1 year
The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.
Primary PK 2
时间窗: through study completion, an average of 1 year
Primary PK parameter is area under plasma concentration time curve (AUC).
Primary PK 3
时间窗: through study completion, an average of 1 year
Primary PK parameter is maximum observed plasma concentration (Cmax).
次要结局
- Progression free survival(through study completion, an average of 1 year)
- Duration of response for responders (CR or PR) and duration of SD (defined only for participants whose confirmed best response is CR, PR, or SD.(through study completion, an average of 1 year)
- The number and proportion of participants who achieve objective tumor response (complete response [CR], partial response [PR], and CR+PR) or stable disease (SD).(through study completion, an average of 1 year)