NCT05566834招募中1 期
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
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To determine any increase of treatment emergent adverse events when Minnelide capsules are given in combination with paclitaxel.
研究概览
简要总结
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.
详细描述
Minnelide™ is a water soluble disodium salt variant of triptolide, a diterpenoid, an HSP70 inhibitor. Studies using orthotopic pancreatic cancer cell lines and human xenograft transplants demonstrate that Minnelide™ prevents tumor progression, increases survival, and causes tumor regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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:
- •Bilirubin 1.5 times upper limit of normal
- •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)
- •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:
- •Granulocyte
- •Monotherapy: ³ 1,500 cells/mm3
- •Combination therapy with paclitaxel: ³ 2,000cells/mm3 Platelet count ³ 100,000 (plt/mm3)
- •Hemoglobin ³ 9 g/dL
- •Urinalysis:
- •o No clinically significant abnormalities
- •Acceptable coagulation status:
- •PT ≤ 1.5 times institutional ULN
- •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 on ECG
- •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 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. 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, non-target 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
研究组 & 干预措施
Open-label, dose-escalation, safety, Pharmacodynamic, pharmacokinetic study.
Experimental
One
干预措施: Minnelide (Drug)
结局指标
主要结局
To determine any increase of treatment emergent adverse events when Minnelide capsules are given in combination with paclitaxel.
时间窗: 24 months
To observe any increase in the number of patients that experience Grade 4 neutropenia lasting ≥ 5 days or Grade 3 or 4 neutropenia with fever and/or infection; Grade 4 thrombocytopenia (or Grade 3 with bleeding); Grade 3 or 4 treatment-related non-hematological toxicity (Grade 3 nausea, vomiting or diarrhea that last \> 72 hours despite maximal treatment when Minnelide is given alone and in combination with paclitaxel compared to the incidence with gemcitabine and nab-paclitaxel.
次要结局
- Plasma levels of Minnelide when given with paclitaxel(24 months)
- Pharmacokinetics of Minnelide when given with paclitaxel(24 months)
研究者
研究点 (1)
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