A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- safety and efficacy
研究概览
简要总结
The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
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
- •≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
- •At least a 14-day period from end of last dose of chemotherapy received
- •Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1
排除标准
- •Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
- •Hematological malignancies
- •Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
- •History of seizure disorder
- •Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension
- •Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)
- •Specified concomitant medications
- •Serum creatinine > 1.5 x upper limit of normal (ULN)
- •Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver metastases; alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to liver or bone metastases; total bilirubin > 1.5 x ULN
- •Radiation therapy within 14 days of study day 1
- •Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1
- •Concurrent radiation therapy is not permitted throughout the course of the study
研究组 & 干预措施
1
BSI-201 + topotecan
干预措施: bsi-201 + topotecan (Drug)
2
BSI-201 + temozolomide
干预措施: bsi-201 + temozolomide (Drug)
3
bsi-201 + gemcitabine
干预措施: bsi-201 + gemcitabine (Drug)
4
bsi-201 + carboplatin/paclitaxel
干预措施: bsi-201 + carboplatin/paclitaxel (Drug)
结局指标
主要结局
safety and efficacy
时间窗: ongoing
Response rate (CR + PR)
时间窗: every 2 cycles
次要结局
未报告次要终点