NCT04280536进行中（未招募）1 期
Phase II Study of FTD/TPI (Lonsurf) in Metastatic Breast Cancers With or Without Prior Exposure to Fluoropyrimidines (LONBRECA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a single arm, open-label, lead in phase Ib dose confirmation, followed by phase II study with 2 parallel study cohorts.
详细描述
Phase Ib Patients will be treated with twice-daily dosing of FTD/TPI in a 3+3 dose escalation design Phase II
Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.
2 parallel cohorts of patients will be enrolled : Cohort A : patients with prior exposure to fluoropyrimidines Cohort B : patients without prior exposure to fluoropyrimidines
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
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years.
- •Histological or cytological diagnosis of breast carcinoma.
- •HER2 negative tumor (IHC 0 -1+ or IHC 2+ and confirmed on HER2 FISH to be negative based on histological report).
- •Patients with HER2 positive tumor may be enrolled if they have failed at least two lines of anti-HER2 based therapies in the metastatic setting, or are intolerant to trastuzumab
- •Any hormone receptor status.
- •Any number of lines of prior palliative endocrine therapy for patients with hormone receptor positive cancer.
- •Has measureable or evaluable disease based on RECIST 1.1 criteria
- •Estimated life expectancy of at least 12 weeks.
- •Has documented progressive disease from last line of therapy.
- •Has recovered from acute toxicities from prior anti-cancer therapies
- •Adequate organ function including the following:
- •oBone marrow: (I) Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L (ii) Platelets ≥100 x 109/L (ii) Hemoglobin ≥8 x 109/L oHepatic: (I)Bilirubin ≤ 1.5 x upper limit of normal (ULN), (ii)ALT or AST ≤ 2.5x ULN, (or ≤ 5 X with liver metastases) oRenal: (I) Creatinine ≤1.5x ULN
- •Signed informed consent from patient or legal representative.
- •Able to comply with study-related procedures.
- •Prior therapy (patients enrolled in phase Ib may be enrolled if they fulfil prior therapy criteria for either Cohort A or Cohort B)
- •Cohort A only: Has received at least 2 lines of palliative systemic therapy, including prior fluropyrimidines (capecitabine, TS-1 or 5-fluorouracil) in the palliative setting, or in the adjuvant setting; patients who have only prior exposure to adjuvant fluoropyrimidines must have relapsed within 12 months of completing adjuvant fluoropyrimidines
- •Cohort B only: Any number of prior lines of palliative chemotherapy and has not received fluoropyrimidines (capecitabine, TS-1 or 5-fluorouracil) in the palliative setting or in the adjuvant setting; patients who have prior exposure to adjuvant fluoropyrimidines are eligible if they have relapsed 12 months from completion of adjuvant fluoropyrimidines.
排除标准
- •Treatment within the last 30 days with any investigational drug.
- •Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- •Major surgery within 28 days of study drug administration.
- •Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- •Pregnancy.
- •Breast feeding.
- •Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- •Active bleeding disorder or bleeding site.
- •Non-healing wound.
- •Poorly controlled diabetes mellitus.
- •Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- •Symptomatic brain metastasis.
- •History of significant neurological or mental disorder, including seizures or dementia.
- •Unable to comply with study procedures
- •Phase Ib lead-in can recruit patients who fulfil criteria for either Cohort A or Cohort B AND all other inclusion/exclusion criteria
研究组 & 干预措施
Cohort A
Experimental
Patients with prior exposure to fluoropyrimidines
干预措施: Cohort A (Drug)
Cohort B
Experimental
Patients without prior exposure to fluoropyrimidines
干预措施: Cohort B (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 4 months
Primary endpoint is proportion of patients who are PFS at 4 months in Cohort A
次要结局
- Overall Response(5 years)
- Progression Free Survival (PFS)(6 months)
- Safety and Efficacy(5 years)
研究者
研究点 (1)
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