A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 321
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.
详细描述
This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups:
- Treatment A (N = 155): Capecitabine + ruxolitinib
- Treatment B (N = 155): Capecitabine + placebo
Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.
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
- Double (Participant, Investigator)
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 adenocarcinoma of the pancreas.
- •Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
- •≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
- •Radiographically measurable or evaluable disease
- •Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
- •mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L
- •mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L
排除标准
- •Received more than 1 prior regimen for advanced or metastatic disease.
- •Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
- •Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
- •Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
- •Prior treatment with a JAK inhibitor for any indication.
研究组 & 干预措施
Ruxolitinib plus capecitabine
干预措施: Ruxolitinib (Drug)
Ruxolitinib plus capecitabine
干预措施: Capecitabine (Drug)
Placebo plus capecitabine
干预措施: Placebo (Drug)
Placebo plus capecitabine
干预措施: Capecitabine (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Randomization until death due to any cause; up to the data cutoff 11FEB2016.
Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
次要结局
- Percentage of Participants Achieving Progression Free Survival (PFS)(Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.)
- Progression-free Survival (PFS)(Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.)
- Duration of Response(Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.)
- Objective Response Rate (ORR)(Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.)
- Participants With Treatment-Emergent Adverse Events (TEAEs)(Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.)