Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine

ASLAN Pharmaceuticals3 个研究点分布在 2 个国家目标入组 31 人开始时间: 2014年8月5日最近更新: 2018年10月25日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: ASLAN Pharmaceuticals
入组人数: 31
试验地点: 3
主要终点: Safety and Tolerability of ASALN001

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a view to identifying the recommended Phase II dose.

详细描述

This is an open-label, Phase I, dose escalation study of ASLAN001 given in combination with Regimen A or Regimen B, in patients with metastatic solid tumors, eligible to receive the cisplatin/5-fluorouracil or cisplatin/capecitabine regimen.

Dose of ASLAN001 starts from 400mg BID; then, dose escalation to 500mg BID or dose de-escalation to 300mg BID will depend on DLTs observed in cohort.

Regimen A: Depends on preferred medical practice, Cohort 1A will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and 5 fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; or will receive ASLAN001 400 mg BID in combination with Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks.

Regimen B: Cohort 1B will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and oral capecitabine 1,000 mg/m2 BID for 14 days every 3 weeks.

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: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female patients 20 years of age or older at the time written informed consent is obtained.
•Regimen A: Patients with metastatic solid tumors eligible for treatment with cisplatin and 5-fluorouracil. The standard dose and schedule of cisplatin and 5-fluorouracil will be according to the preference of investigators and institutions.
•Regimen B: Patients with metastatic solid tumors eligible for treatment with cisplatin in combination with capecitabine.
•Patients with a partial gastrectomy may be allowed to participate in the study as long as they can take oral medications and meet all other inclusion/exclusion criteria.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to enrolment:
•Hematological function, as follows:
•Absolute neutrophil count ≥ 1.5 x 109/L.
•Platelet count ≥ 100 x 109/L.
•Hemoglobin ≥ 9 g/dL.
•Coagulation function, as follows:
•Partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
•International normalized ratio ≤ 1.
•Renal function, as follows:
•Creatinine clearance ≥ 50 mL/min as calculated by Cockcroft-Gault formula.
•Hepatic function, as follows:
•Total bilirubin ≤ 1.5 x ULN.
•AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present).

排除标准

•Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.
•Patients receiving proton pump inhibitors or H2 antagonists for established, symptomatic gastro duodenal ulceration or gastroesophageal reflux disease.
•Patients with unresolved toxicities of grade 2 or more from prior anti-cancer therapies.
•Untreated or symptomatic central nervous system metastases. Patients with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the patient is clinically stable and is off corticosteroids for at least 2 weeks prior to enrolment.
•Major surgical procedures within 28 days prior to enrolment.
•Clinically significant cardiovascular diseases that are symptomatic or uncontrolled.
•Known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen.
•Pregnant or breast-feeding females.
•Patients who have hearing impairment, due to the potential for ototoxicity of cisplatin.
•Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results