A Phase-I Clinical Study to Evaluate the Safety, Pharmacokinetics and Anti-Tumor Activity of NRC-AN-019 in Patients with Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- To estimate the Dose Limiting Toxicity and Maximum Tolerated Dose of NRC-AN-019
研究概览
简要总结
This is a multicentric open label Phase-I clinical study to evaluate the safety & efficacy of NRC-AN-019 in patients with Non-Small Cell Lung cancer or Metastatic Breast Cancer or Pancreatic Cancer or Malignant Glioma. NRC-AN-019 will be given as capsules of 200 mg in patients with any of the above indications enrolled at five centers in India. The primary outcome would be the estimation of dose limiting toxicity and maximum tolerated dose of the study drug. The secondary outcome would be the characterization of pharmacokinetics and efficacy of the study drug.The stimated sample size of the study is 72 completed patients from five centers only in India. The study is anticipated to start enrollment by November 20, 2009.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
入选标准
- •Patients must be greater than or equal 18 years old with expected life expectancy greater than 8 weeks.
- •Patients with disease not responding to currently available treatment options.
- •Patients must have recovered from the toxic effects of earlier radiotherapy or chemotherapy (if any)
- •Patients must have adequate bone marrow reserve
- •Patients must be willing to practice birth control during and for two months after treatment with study drug
- •Patients who are willing and able to give informed consent
- •Patients should have ECOG performance status less than or equal to 2.
排除标准
- •Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy.
- •Concurrent use of other chemotherapeutic agents
- •Pregnancy or lactation or non-practice of birth control during and for 2 months after treatment with study drug
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, and which may obscure the evaluation of toxicity or alters drug metabolism.
结局指标
主要结局
To estimate the Dose Limiting Toxicity and Maximum Tolerated Dose of NRC-AN-019
时间窗: 30 days
次要结局
- To characterize the Pharmacokinetics and therapeutic efficacy of NRC-AN-019(30 days)