NCT00300950已完成2 期
A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo, in Patients With Post-resection R0/R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations.
GlobeImmune28 个研究点 分布在 2 个国家目标入组 176 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 28
- 主要终点
- Recurrence free time and survival
研究概览
简要总结
The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation
- •>18 years of age
- •Negative skin test for hypersensitivity to Saccharomyces cerevisiae
排除标准
- •Metastatic pancreas cancer patients post-resection
- •Patients with no product-related ras mutation.
研究组 & 干预措施
1
Active Comparator
Gencitabine
干预措施: GI-4000 (Biological)
2
Experimental
Gemcitabine with GI-4000
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Recurrence free time and survival
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (28)
Loading locations...
相似试验
进行中（未招募）
2 期
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy InfantsPneumococcal VaccinesNCT06720038Vaxcyte, Inc.900
进行中（未招募）
2 期
Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent VaccineCondylomata AcuminataNCT02710851Jun Zhang640
已完成
2 期
Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) CapsidHuman Immunodeficiency Virus InfectionsHIV InfectionsNCT00888446International AIDS Vaccine Initiative91
Unknown
3 期
Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust MitesAllergic RhinitisNCT01013116Roxall Medizin120
已完成
2 期
Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and OlderSARS-CoV-2NCT04405076ModernaTX, Inc.660