A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 56
- 主要终点
- Progression free survival
研究概览
简要总结
This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.
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
- •Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
- •The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
- •Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
- •Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
- •The presence of a mass in the pancreas OR
- •A history of resected pancreatic carcinoma
- •Measurable disease per RECIST (ver. 1.1)
- •ECOG Performance Status of 0 or
- •Adequate hepatic, hematologic and renal functions.
排除标准
- •A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
- •A diagnosis of pancreatic islet neoplasms.
- •Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
- •Presence of biliary obstruction requiring external drainage
- •Brain metastases.
- •Unstable cardiovascular function within the last 6 months of screening
- •Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
- •Known HIV infection.
- •Uncontrolled hypertension at Screening
- •History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
- •Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
- •Uncontrolled systemic fungal, bacterial or viral infection
- •Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study
研究组 & 干预措施
Simtuzumab (open-label)
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Simtuzumab (Drug)
Simtuzumab (open-label)
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Gemcitabine (Drug)
Simtuzumab 200 mg (randomized)
Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Simtuzumab (Drug)
Simtuzumab 200 mg (randomized)
Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Gemcitabine (Drug)
Simtuzumab 700 mg (randomized)
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Simtuzumab (Drug)
Simtuzumab 700 mg (randomized)
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Gemcitabine (Drug)
Placebo (randomized)
Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Gemcitabine (Drug)
Placebo (randomized)
Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
干预措施: Placebo to match simtuzumab (Drug)
结局指标
主要结局
Progression free survival
时间窗: Up to 3 years
Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.
次要结局
- Overall survival(Up to 3 years)
- Objective response(Up to 3 years)