KCT0002037招募中未知
A Phase I/II Study of Combination Therapy of CG200745 PPA (Histone Deacetylase Inhibitor) with Gemcitabine and Erlotinib to Determine the Maximum Tolerated Dose and Evaluate the Safety and Efficacy for Locally Advanced Unresectable, or Metastatic Pancreatic Cancer
CrystalGenomics0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1)Ages : = 20 and = 75 years
- •2)Subjects who join voluntarily for participation in the study, sign the consent form and are willing to comply the clinical trial procedure
- •3)Subjects who have diagnosed with unresectable, locally advanced, metastatic, histologically and cytologically confirmed pancreatic adenocarcinoma.
- •4)ECOG (Eastern Cooperative Oncology Group) performance status : 0-2
- •5)Estimated life expectancy at the time of enrollment is more than 3 months
- •6)Adequate hematological, renal and hepatic function
- •ANC (Absolute neutorphil count) = 1500/mm3, hemoglobin = 9.0 g/dl (eligible if hemoglobin lab values are adjusted with blood transfusion), platelet = 100,000/mm3
- •Within normal range of serum creatinine or CCr = 60 ml/min (using Cockcroft-Gault equation )
- •Subjects who have no abnormal serum electrolyte values (including calcium, magnesium, phosphorous and potassium). However, the supplementation therapy is allowed for normalization of serum electrolytes.
- •? Normal reference range for Calcium: 8.3~10.5 mg/dl, Magnesium: 1.58~3.0 mg/dl, Phosphorous: 2.4~4.5 mg/dl, Potassium: 3.3~5.5 mmol/L
- •Serum bilirubin < 2 x ULN, AST/ALT < 2.5 x ULN, ALP < 5 x ULN (If liver metastasis, AST/ALT <5 x ULN)
- •PT or PTT = 1.5 x ULN (except for the use of anticoagulant, in this case, PT/PTT stabilization for up to 2 weeks should be confirmed)
- •7)No prior chemotherapy, radiation or biologics
排除标准
- •1)Subject who had experienced a major surgery within 2 weeks prior to the screening visit
- •2)Subject with an evidence for uncontrolled brain metastasis (except for the patients with radiologically and neurologically stable brain metastasis without corticosteroid therapy for at least two weeks)
- •3)Subject who cannot be administered oral drug, or have difficulty to absorb the study drugs due to a history of major gastrointestinal surgery or pathological findings.
- •4)Subjects who have treated antibiotics within last seven days due to an active bacterial infection prior to the enrollment. (Topical antibiotic therapies are excluded)
- •5)Subjects who had experienced any malignancies within past 5 years, except for basal cell skin cancer, in situ cervical cancer, or papillary thyroid tumor.
- •6)Pregnancy or Lactating
- •7)Fertile subjects who do not agree with the effective contraception during the study period and up to 3 months after the completion of the study. The following cases are exceptions: an irreversible and surgical sterility by hysterectomy, bilateral oophorectomy or bilateral salpingoectomy, and menopausal women over 50 years old with no menstruation for at least 12 months and without hormonal therapy. Tubal ligation is not regarded as an effective contraception.
- •8)Subject who cannot take anti-cancer chemotherapy due to a systemic disease (ex. chronic renal failure)
- •9)Subjects who have treated with any other investigational drug within 4 weeks prior to the screening visit
- •10) History of hypersensitivity to study drug
- •11) Subject with HIV positive
研究者
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