EUCTR2007-005386-35-BG进行中（未招募）不适用
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.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 Subjects must have resectable pancreas cancer, ductal adenocarcinoma type, with post-resection confirmation of non-metastatic disease.
- •2 Confirmed product related mutation in Ras from tumor sample.
- •3 ECOG performance status (PS) of =2 prior to randomization.
- •4 Confirmed R0 or R1 status post-resection.
- •5 Negative scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae.
- •6 Age =18 years.
- •7 Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1 Non-resectable pancreatic cancer, or histologic types other than ductal adenocarcinoma (e.g. papillary cystoadenocarcinoma, mucinous cystoadenocarcinoma). Tumors classified as T4.
- •2 Prior chemotherapy, radiation therapy, targeted therapy, or immunotherapy for pancreatic cancer.
- •3 History of another cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma of the skin, Stage 1A cervical cancer, or melanoma in situ.
- •4 History of splenectomy.
- •5 History of Crohn’s disease or ulcerative colitis.
- •6 History of major organ transplantation.
- •7 Concurrent and chronic therapy with corticosteroids (greater than 10 mg per day of prednisone or an equipotent dose of another corticosteroid) or any other immunosuppressive drugs. Use of dexamethasone as an antiemetic during gemcitabine dosing will be permitted during the trial.
- •8 History of allergy to S. cerevisiae.
- •9 Presence of an unstable or poorly controlled medical condition that in the opinion of the principal investigator may impair the ability of the subject to participate safely or to potentially benefit from the study.
- •10 Pregnancy and nursing mothers.
- •11 Alcohol and/or IV drug abuse within the past year.
- •12 Participation in any experimental treatment protocol or therapy within 28 days before screening (experimental peri-operative procedures such as the use of novel drains which are anticipated to affect the acute post-operative course, may be allowed after discussion with the medical monitor).
- •13 History of autoimmune disease (subjects with a history of resolved autoimmune thyroiditis may be eligible with consultation of the study medical monitor).
- •14 Known history of hypersensitivity to gemcitabine.
- •15. High risk for noncompliance with the protocol.
研究者
相似试验
招募中
2 期
Chemoimmunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Ovarian, CancerCTRI/2022/10/046210OncoQuest Pharmaceuticals Inc
进行中（未招募）
1 期
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of IntracoronaryAdministration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart FailureEUCTR2012-001700-37-HUCelladon Corporation250
进行中（未招募）
不适用
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart FailureModerate to advanced heart failure (NYHA class II, III or IV) due to systolic dysfunctionMedDRA version: 18.0Level: LLTClassification code 10010684Term: Congestive heart failureSystem Organ Class: 100000004849EUCTR2012-001700-37-PLCelladon Corporation250
进行中（未招募）
1 期
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart FailureModerate to advanced heart failure (NYHA classII, III or IV) due to systolic dysfunctionMedDRA version: 18.0Level: LLTClassification code 10010684Term: Congestive heart failureSystem Organ Class: 100000004849EUCTR2012-001700-37-DKCelladon Corporation250
进行中（未招募）
不适用
A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart FailureModerate to advanced heart failure (NYHA class II, III or IV) due to systolic dysfunctionMedDRA version: 18.0Level: LLTClassification code 10010684Term: Congestive heart failureSystem Organ Class: 100000004849EUCTR2012-001700-37-BECelladon Corporation250