KCT0006519招募中未知
A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules given alone or in combination with Paclitaxel in patients with Advanced Gastric Cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 18
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
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Patients with histologically confirmed advanced gastric cancer
- •Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy
- •One or more metastatic tumors measurable per RECIST v1.1 Criteria
- •Karnofsky performance = 70%
- •Life expectancy of at least 3 months
- •Age ³ 19 years
- •Signed, written IRB-approved informed consent
- •A negative pregnancy test (if female)
- •Acceptable liver function:
- •o Bilirubin £ 1.5 times upper limit of normal
- •o AST (SGOT), ALT (SGPT) and Alkaline phosphatase £ 2.5 times upper limit of normal
- •(if liver metastases are present, then £ 5 x ULN is allowed)
- •o Albumin = 3.0 g/dL
- •Acceptable renal function:
- •o Serum creatinine within normal limits, OR calculated creatinine clearance ³ 60
- •mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Acceptable hematologic status:
- •o Granulocyte
- •? Monotherapy: ³ 1,500 cells/mm3
- •? Combination therapy with paclitaxel: ³
- •2,000 cells/mm3
- •o Platelet count ³ 100,000 (plt/mm3)
- •o Hemoglobin ³ 9 g/dL
- •Urinalysis:
- •o No clinically significant abnormalities
- •Acceptable coagulation status:
- •o PT = 1.5 times institutional ULN
- •o PTT = 1.5 times institutional ULN
- •Women of child- bearing potential and men must agree to use adequate contraception For men and women of child-producing potential, the use of
- •effective contraceptive methods during the study and until 90 days after the last dose of IP for men or until 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women.
排除标准
- •New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia
- •Baseline QTc exceeding 470 msec (using the Bazett’s formula) and/or patients receiving class 1A or class III antiarrhythmic agents.
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- •Pregnant or nursing women. NOTE: For men and women of child-producing potential, the use of effective contraceptive methods during the study and until 90 days after the last dose of IP for men or untill 6 months after the last dose of IP for women or 6 months after the last dose of IP with paclitaxel for both men and women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Treatment with radiation therapy (local therapy, nontarget lesion, 2 weeks), major surgery, chemotherapy, biological agents or investigational therapy within 3
- •weeks prior to study treatment.
- •Unwillingness or inability to comply with procedures required in this protocol
- •Known infection with HIV, hepatitis B, or hepatitis C
- •Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •Patients who are currently receiving any other investigational agent
- •Patients who are on a prohibited medication (section 4.3.2).
- •Patients with biliary obstruction and/or biliary stent
- •(Regimen B only)
- •Patients with a history of severe hypersensitivity
- •reactions to products containing Cremophor® EL (eg, cyclosporin for injection concentrate and teniposide for injection concentrate).
- •Patient with baseline ANC<1500/mm3
研究者
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