KCT0009067尚未招募Unknown
Phase 1b/2 trial for venadaparib in combination with paclitaxel and ramucirumab as a second-line therapy for gastric cancer with homologous recombination repair deficiency
ational Cancer Center0 个研究点目标入组 75 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Pathologically or cytologically confirmed gastric adenocarcinoma
- •2. You are at least 19 years of age on the date you sign the consent form
- •3. Patients with ECOG performance status 0-2
- •4. Patients with expected survival > 12 weeks.
- •5. Persons with confirmed adequate organ function, as defined in the applicable section below;
- •1) Absolute neutrophil count (ANC) = 1.0 x 109/L (=1,000 per mm3)
- •2) Platelet count = 100 x 109/L (=100,000 per mm3)
- •3) Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). (Gilbert's syndrome is an exception).
- •4) AST (SGOT)/ALT (SGPT) = 2.5 x institutional UNL (However, if liver metastases = 5x ULN)
- •5) 24-h urine creatinine clearance or eGFR > 40 mL/min
- •6. For women, negative pregnancy test or non-fertile women defined as:
- •1) Medical history of menopause (absence of menstruation for more than 1 year without other medical reasons)
- •2) Patients who have undergone hysterectomy or bilateral tubal ligation or bilateral oophorectomy
- •7. Patients who are intolerant to first-line therapy for the treatment of metastatic gastric cancer, show progressive disease after taking first-line therapy, or receive anticancer drugs used as adjuvant chemotherapy or stop (based on the date of the last anticancer drug administration) 6 If disease progression is shown within 12 months (provided that the above anti-cancer therapy (first-line or adjuvant) must include a fluoropyrimidine drug; and in the case of phase 1b, disease progression after administration of two or more anti-cancer drugs administered for the treatment of metastatic gastric cancer) However, if there is a defect in homologous recombination repair described in item 8 below, disease progression after administration of one anticancer drug can also be registered)
- •8. Homologous recombination repair defect in whole-length exome genome test or overexpression of CDK8/19 in proteomic analysis (but not applicable in group 1b)
- •- HRD score of 42 or higher or HRDetect 0.7 or higher on whole exome sequencing suggests homologous recombination repair defect
- •-When a pathogenic germline/somatic mutation is found in one of the genes
排除标准
- •1. As of the first day of administration of this clinical trial drug (Cycle 1 Day 1), the last day of systemic anticancer treatment (including immunotherapy
- •and small molecule targeted therapy) was less than 14 days.
- •B, the last administration date of monoclonal antibody is less than 28 days, or the last administration date of nitrosourea/mitomycin C is less than
- •42 days (even if the relevant period has not elapsed)
- •Obtaining consent and conducting screening tests are possible)
- •2. History of primary cancer other than stomach cancer
- •However, exceptions are made in the following cases:
- •1) Patients with cancer that has undergone curative treatment who have been disease-free for more than 3 years and have a low risk of recurrence
- •2) Patients who are currently disease-free with cured skin cancer (non-melanoma skin cancer, lentigo maligna)
- •3) Patients with cured in situ carcinoma who are currently disease-free
- •3. Any condition, treatment or history of the test subject that, in the researcher's judgment, makes it difficult to evaluate the clinical trial results.
- •4. Uncontrolled active infection, symptomatic heart failure, uncontrolled hypertension/unstable angina/arrhythmia, active bleeding tendency, active
- •hepatitis, impairing written consent.
- •Mental illness or social situation that causes
- •5. Patients with a history of leptomeningeal metastasis.
- •6. Patients with brain metastases or spinal nerve compression whose symptoms are not controlled (patients whose symptoms have stabilized after
- •discontinuing anticonvulsants at least 14 days prior to administration of the clinical trial drug can be registered)
- •7. Uncontrolled seizures
- •8. Pregnant or potentially pregnant women and lactating women, men or pregnant women who are not willing to use appropriate contraception until
- •180 days after the end of the clinical trial.
- •9. Patients who have ever received PARP inhibitors
- •10. Patients who have received taxane as treatment for metastatic gastric cancer
- •11. Dialysis patients
研究者
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