A Randomized, Open Label, Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
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
- 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
- •Male, or non-pregnant and, non-lactating female
- •Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
- •Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per National Comprehensive Cancer Network® [NCCN®] criteria)
- •Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted.
- •Measurable disease as defined by RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate liver, bone marrow, and renal function
- •Agree to use contraception per protocol
- •Less than Grade 2 pre-existing peripheral neuropathy
排除标准
- •Prior chemotherapy or radiation for pancreatic cancer
- •Solid tumor contact with superior mesenteric artery (SMA) >180°
- •Previous (within the past 5 years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer and in situ carcinomas)
- •Major surgery, within 4 weeks prior to Day 1 on study
- •History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
- •Exposure to another investigational drug within 42 days of first dosing visit, or 5 half-lives of the study product (whichever is longer)
- •Uncontrolled intercurrent illness
- •Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a participant in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
- •Current abuse of alcohol or drugs
研究组 & 干预措施
FG-3019 + Gemcitabine + Nab-paclitaxel
Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
干预措施: FG-3019 (Drug)
FG-3019 + Gemcitabine + Nab-paclitaxel
Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
干预措施: Gemcitabine (Drug)
FG-3019 + Gemcitabine + Nab-paclitaxel
Participants will receive FG-3019 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion on Days 1 and 15 of each treatment cycle and on Day 8 of the first cycle, gemcitabine 1000 mg/square meter (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
干预措施: Nab-paclitaxel (Drug)
Gemcitabine + Nab-paclitaxel
Participants will receive gemcitabine 1000 mg/ meter squared (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
干预措施: Gemcitabine (Drug)
Gemcitabine + Nab-paclitaxel
Participants will receive gemcitabine 1000 mg/ meter squared (m^2) and nab-paclitaxel 125 mg/m^2 by IV infusion on Days 1, 8, and 15 of each treatment cycle. Treatment will be administered over a 28-day cycle, for up to 6 cycles.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Number of Participants Who Had Surgical Complications Post-Resection
时间窗: 30 days following discharge after surgery (up to Day 198)
Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported
次要结局
- Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(From randomization up to Week 52)
- Number of Participants Who Became Eligible for Surgery(After completion of 24 weeks of treatment with study drug)
- Median Progression-Free Survival(From randomization until objective tumor progression or death, assessed up to 4 years)
- Median Overall Survival(From randomization until death from any cause, assessed up to 4 years)
- Number of Participants in Whom R0 or R1 Resection Was Achieved(After completion of 24 weeks of treatment with study drug)
- Number of Participants in Whom R0 Resection Was Achieved(After completion of 24 weeks of treatment with study drug)