NCT03200821已完成3 期
A Phase 3 Study to Evaluate the Efficacy and Safety of 250 µg G17DT or 1000 µg/m^2 Gemcitabine in Subjects With Advanced Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 103
- 主要终点
- Survival
研究概览
简要总结
In this study 250 µg of G17DT was administered at Weeks 0, 2 and 6 in order to demonstrate non inferiority compared to gemcitabine in prolonging survival in advanced 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
- •A diagnosis of pancreatic adenocarcinoma, confirmed by histology or cytology, in patients not suitable for pancreatic tumor resection with curative intent.
- •A diagnosis of recurrent pancreatic adenocarcinoma (previously confirmed by histology or cytology) in patients who have had a primary tumor resection.
- •Male or female patients over 18 years of age.
- •Laboratory values within the following ranges at screening:
- •Serum creatinine < 1.25 times upper limit of normal (ULN) Haemoglobin > 9.5 g/dL White blood cell (WBC) count > 3.5 x 109/L Platelets > 100 x 109/L Total bilirubin < 2.0 times ULN Aspartate transaminase (AST, SGOT) < 3 times ULN
- •A life expectancy of at least 2 months.
- •A negative pregnancy test at the screening visit (females of childbearing potential only).
- •Signed written informed consent.
排除标准
- •History of other malignant disease (except basal cell carcinoma or in situ carcinoma of the uterine cervix).
- •Previous cytotoxic chemotherapy (including gemcitabine).
- •Previous radiotherapy within 30 days of baseline.
- •Use of systemic (oral or injected) immunosuppressants, including corticosteroids, within 30 days prior to the baseline visit. Inhaled corticosteroids for chronic obstructive pulmonary disease or asthma were permitted.
- •Females of child bearing potential who are pregnant, lactating, or who are planning to become pregnant during the period of the study.
- •Participation in another study involving an investigational drug within 90 days of baseline.
研究组 & 干预措施
G17DT
Experimental
250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
干预措施: G17DT (Biological)
Gemcitabine
Active Comparator
1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Survival
时间窗: Baseline (Week 0) up to Week 52 or death.
Survival in days measured starting at Baseline
次要结局
- Tumor Response(Weeks 0, 12, 24, 36 and 52)
- Quality of Life(Weeks 0, 6, 12, 24, 36 and 52)
- Karnofsky Performance Status(Week 0 to Week 52)
- Gastrin-17 Antibodies(Weeks 0, 6, 12, 24, 36 and 52)
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