A Randomized, Phase 2 Study of Itacitinib or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 16
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The primary objectives of this study were to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion), and to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone (Part 2, randomized portion).
详细描述
The secondary objectives of this study (Part 2) were to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone.
Part 2 of the study was not conducted.
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
- •Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
- •Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Life expectancy of ≥12 weeks.
排除标准
- •Received prior treatment with docetaxel.
- •Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
- •No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
- •Subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
- •Peripheral neuropathy ≥ Grade
- •Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
- •Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
- •Unwilling to be transfused with blood components.
研究组 & 干预措施
Itacitinib plus docetaxel
Itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously
干预措施: docetaxel (Drug)
Itacitinib plus docetaxel
Itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously
干预措施: Itacitinib (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: Baseline through 21 days; the end of cycle 1.
Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
次要结局
未报告次要终点