A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 13
- 主要终点
- Identify dose-limiting toxicities (DLT) of FF-10832
研究概览
简要总结
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid tumors including biliary tract cancer
详细描述
Dose-escalation Phase:
Eligible patients will receive FF-10832 in 28 day or 21 day cycles. Dosing will continue until progression of disease, observation of unacceptable adverse events, intercurrent illness, or changes in the patient's condition that prevents further study participation after discussion between the Investigator and the Medical Monitor. A number of cohorts will be enrolled sufficient to determine the MTD and to identify the RP2D.
Expansion Phase:
One cohort of biliary tract cancer will enroll up to 18 patients in a 21 day cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
None, open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 years of age
- •Histologically or cytologically confirmed metastatic solid tumor, relapsed or refractory to standard therapy, or for which no standard therapy is available that is expected to improve survival by at least three months
- •At least 3 weeks beyond the last chemotherapy (or 3 half-lives, whichever is shorter), radiotherapy, major surgery, or experimental treatment, and recovered from all acute toxicities (≤ Grade 1), prior to the first dose of FF-10832
- •Cohort expansion phase: (biliary tract cancer):
- •Histologically or cytologically confirmed cholangiocarcinoma or gall bladder carcinoma that is metastatic pancreatic adenocarcinoma following progression or relapseor unresectable
- •Measurable disease by RECIST 1.1
- •Progressed on at least one prior regimengemcitabine-cisplatin therapy or gemcitabine-based therapy if unable to tolerate cisplatin. Adjuvant therapy counts as such therapy.
- •Progressed on, declined on, or was ineligible for therapies directed against fibroblast growth factor (FGFR) and/or isocitrate dehydrogenase (IDH) mutations for tumors appropriately treated with such therapies
- •No more than 3 prior systemic therapies for their tumor. Please contact the medical monitor if there are any questions about eligibility.
- •A serum albumin level ≥ 3 g/dL on entry to the study
- •Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1
- •Life expectancy of ≥ 3 months
- •Ability to provide written informed consent
排除标准
- •Patients who have not received standard/approved therapies expected to improve survival by at least 3 months
- •Prior hypersensitivity to gemcitabine
- •Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
- •7. Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
- •8. Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
- •9. Pregnant or breast-feeding
研究组 & 干预措施
Cohort 1: Treatment at 1.2 mg/m2
FF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
干预措施: FF-10832 Gemcitabine Liposome Injection (Drug)
Cohort 3: Treatment at 4.8 mg/m2
FF-10832 Gemcitabine Liposome Injection, 4.8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
干预措施: FF-10832 Gemcitabine Liposome Injection (Drug)
Cohort 4: Treatment at 8 mg/m2
FF-10832 Gemcitabine Liposome Injection, 8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
干预措施: FF-10832 Gemcitabine Liposome Injection (Drug)
Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)
For patients with biliary tract cancer: FF-10832 Gemcitabine Liposome Injection, RP2D administered intravenously (IV) on Day 1 of each 21-day cycle
干预措施: FF-10832 Gemcitabine Liposome Injection (Drug)
Cohort 2: Treatment at 2.4 mg/m2
FF-10832 Gemcitabine Liposome Injection, 2.4 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
干预措施: FF-10832 Gemcitabine Liposome Injection (Drug)
结局指标
主要结局
Identify dose-limiting toxicities (DLT) of FF-10832
时间窗: 2.5 years
DLT is defined as any adverse event at least possibly related to FF-10832, and meeting specified DLT criteria
Determine maximun tolerated dose (MTD) of FF-10832
时间窗: 2.5 years
MTD is defined as the next lower dose of a cohort where patients experienced a DLT
Determine incidence of Treatment Emergent Adverse Events (TEAE)
时间窗: 2.5 years
Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Progression-free survival (PFS)(2.5 years)
- Disease Assessment by CT or MRI scan for solid tumors(2.5 years)
- Disease Assessment by CT or MRI + PET scan for pancreatic cancer(2.5 years)
- Duration of Response(2.5 years)
- Overall survival (OS)(2.5 years)
- Duration of Stable Disease(2.5 years)
- Time to progression (TTP)(2.5 years)