A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.
详细描述
The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population.
A randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug).
Treatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.
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
- Triple (Participant, Care Provider, 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
- •18 years of age or older
- •Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or evaluable disease that was histologically confirmed
- •Karnofsky performance status of ≥ 60
- •Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic cancer:
- •o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy in the event that the subject was intolerant to or ineligible to receive gemcitabine
- •≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have recovered or been at new stable baseline from any related toxicities
排除标准
- •More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic disease
- •Evidence of central nervous system (CNS) metastases (unless stable for > 3 months) or history of uncontrolled seizures
- •Ongoing radiation therapy or prior radiation therapy administered as a second-line treatment
- •Other active malignancy except basal or squamous carcinoma of the skin
- •Inability to swallow food or any condition of the upper GI tract that precluded administration of oral medications
- •Inadequate renal, hepatic and bone marrow function demonstrated by clinical observations and/or laboratory assessments
研究组 & 干预措施
Capecitabine and ruxolitinib
干预措施: Capecitabine (Drug)
Capecitabine and ruxolitinib
干预措施: Ruxolitinib (Drug)
Capecitabine and placebo
干预措施: Capecitabine (Drug)
Capecitabine and placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).
Overall survival was measured as the length of time (in days) between the randomization date and the date of death.
次要结局
- Objective Response Rate(Measured every 4 weeks for duration of study treatment (up to 8 months))
- Durable Response Rate(Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months))
- Summary of Clinical Benefit(Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months))
- Progression-Free Survival (PFS)(Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.)