A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel Combined With OGX-427 Or Placebo In Patients With Metastatic Pancreatic Cancer (The Rainier Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 11
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to compare the overall survival in patients with previously untreated metastatic pancreatic cancer receiving gemcitabine/nab-paclitaxel plus OGX-427 or gemcitabine/nab-paclitaxel plus placebo.
详细描述
Patients with pancreatic cancer usually present with inoperable disease and systemic therapy becomes the primary form of treatment. The combination of gemcitabine plus nab-paclitaxel represents an appropriate front-line standard of care for patients with metastatic pancreatic cancer. However, poor outcomes with this disease warrant exploration of novel drugs with unique mechanisms of action. Preclinical evidence suggests that OGX-427 has shown promising activity in pancreatic cancer. In this trial, we will compare the overall survival of patients with previously untreated metastatic pancreatic cancer using OGX-427 with either gemcitabine/nab-paclitaxel or a placebo with gemcitabine/nab-paclitaxel.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 pancreatic adenocarcinoma
- •Stage IV disease (measurable disease NOT required)
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
- •At least 18 years of age
- •Female patients who are not of child-bearing potential, and fertile female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of randomization.
- •Fertile male patients willing to use adequate contraceptive measures.
- •Adequate bone marrow, renal, and hepatic function.
- •Ability to understand the nature of this study protocol, comply with study and/or follow-up procedures, and give written informed consent
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant or neoadjuvant setting is permissible as long as it was completed > 6 months prior to the time of study randomization.
- •History of other diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
- •Presence of known central nervous system or brain metastases.
- •Known human immunodeficiency virus (HIV) infection.
- •Active second invasive malignancy (except non-melanomatous skin cancer), defined as any malignancy with current need for cancer therapy or high possibility (>30%) of recurrence during the study.
- •Patients receiving warfarin. However, therapeutic anticoagulation with Low Molecular Weight Heparin (LMWH) is allowed.
- •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
- •Current sensory neuropathy > Grade
- •Major surgery within 4 weeks of the start of study treatment (defined as those surgeries that require general anesthesia. Insertion of a vascular access device is NOT considered major surgery.). Patients must have recovered from the side effects of any major surgery prior to randomization.
研究组 & 干预措施
OGX-427
Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8, 15, and 22 of each 28 day cycle during the Treatment Phase.
干预措施: OGX-427 (Drug)
Placebo
Three loading doses of placebo will be administered Days -9 to -1. Following the loading dose period, placebo will be administered weekly Days 1, 8, 15, and 22 of each 28 day cycle.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to 2 years
Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.
次要结局
- Progression-Free Survival(Every 8 weeks up to 2 years)
- Objective Response Rate(Every 8 weeks for up to 2 years)