EUCTR2015-001526-42-HU进行中（未招募）1 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined with mFOLFOX6 as First Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 430
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
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- •1. Male or female = 18 years of age
- •2. Histologically confirmed adenocarcinoma of the stomach or GEJ with inoperable, locally advanced or metastatic disease, not amenable to curative therapy
- •Adenocarcinoma of the GEJ is defined as tumors that have their center within 5 cm proximal and distal of the anatomical esophago-gastric junction as described in Siewert’s classification system
- •3. Eastern Cooperative Oncology Group (ECOG) = 1
- •4. Measurable disease or non-measurable but evaluable disease, according to RECIST v1.1. Subjects with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial
- •5. Subjects not receiving anticoagulant medication must have an international normalized ratio (INR) = 1.5 and activated partial thromboplastin time (aPTT) = 1.5 X upper limit of normal (ULN)
- •The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the subject has been on stable dose of anticoagulants for at least 1 week at the time of randomization.
- •6. Adequate hematologic function:
- •a. neutrophils = 2.0 x 10^9/L
- •b. platelets = 100 x 10^9/L
- •c. haemoglobin = 9 g/dL
- •7. Adequate hepatic function:
- •a. Direct or total bilirubin = 1.5 x ULN.
- •b. ALT and AST = 2.5 x ULN, in case of liver metastases = 5 x ULN
- •8. Creatinine clearance (CLcr) should be = 30 mL/min based on the Cockroft -Gault formula. Subjects with a CLcr just below 30 mL/min may be eligible if a measured CLcr (based on 24 hour urine collection or other reliable method) is = 30 mL/min
- •9. For female subjects of childbearing potential, willingness to use a protocol recommended method of contraception from the screening visit throughout the study treatment period, for 90 days following the last dose of study drug (GS-5745/placebo), and for 4 months after the last dose of oxaliplatin or 6 months after the last dose of 5-FU whichever occurs later, unless the subject chooses continuous heterosexual abstinence as a lifestyle-choice
- •10. For male subjects of reproductive potential, willingness to use a protocol-recommended method of contraception and to refrain from sperm donation from the start of study drug, throughout the study treatment period, for 90 days after administration of the last dose of any study drug, and for 6 months after the last dose of oxaliplatin or 6 months following the last dose of 5-FU whichever occurs later
- •11. Breastfeeding females must agree to discontinue nursing before study drug administration
- •12. In the judgment of the investigator, participation in the protocol offers an acceptable benefit to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject’s cancer
- •13. Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions
- •14. Evidence of a signed informed consent prior to
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be randomized in this study:
- •1. Previous chemotherapy for locally advanced or metastatic gastric cancer. Subjects may have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to randomization
- •2. Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer (primary tumor or metastatic lesion). HER2-positivity is defined as either IHC3+ or IHC2+/ISH+ (ISH positivity is defined as a
- •HER2:CEP17 ratio of =2.0)
- •3. Patients who have received palliative radiation and have not
- •recovered from all acute, reversible effects
- •4. Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, active gastrointestinal bleeding, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
- •5. History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for = 1 year prior to randomization, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for = 5 years
- •6. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy), within 28 days of first dose of study drug
- •7. Known positive status for human immunodeficiency virus (HIV)
- •8. Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •9. Peripheral neuropathy = Grade 2 according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v.4.03)
- •10. Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day methylprednisolone equivalent). Inhaled steroids and short courses of oral steroids for anti emesis or as an appetite stimulant are allowed
- •11. Pregnant or breastfeeding women (pregnancy needs to be excluded by testing of beta-human chorionic gonadotropin [ß-hCG])
- •12. Known or suspected central nervous system metastases
- •13. Known dihydropyrimidine dehydrogenase-deficiency (special screening not required)
- •14. Known alcohol or drug abuse or any other medical or psychiatric condition which contraindicates participation in the study
- •15. Documented myocardial infarction or unstable/uncontrolled cardiac disease (ie, unstable angina, congestive heart failure [New York Heart Association > Class II]) within 6 months of randomization
- •16. Active tuberculosis or history of latent tuberculosis that has not been treated
- •17. Any chronic medical condition that, in the opinion of the Investigator, would make the subject unsuitable for the study or would prevent compliance with the study protocol
- •18. Serious systemic fungal, bacterial, viral, or other
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