A Phase I, Open-Label, Dose Escalation Study of Intravenously Administered NS-9 in Subjects With Liver Metastases From Various Primary Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
研究概览
简要总结
This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.
详细描述
This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period. During the rest period, subjects are seen at the clinic once weekly for evaluation. Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in the extension phase of the study until the disease progresses or until they get a side effect that prevents them from continuing with therapy.
After each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and female at least 18 years of age.
- •Patients with liver metastases from various primary cancers for which no other curative treatment options exist.
- •At least one measurable lesion (by CT or MRI)
- •Life expectancy > 3 months
- •Child-bearing potential women must have a negative serum pregnancy test
- •ECOG performance status: 0-1
- •Fully recovered from any previous cancer therapy or infection (at least 4 weeks from radiation or chemotherapy, at least 3 weeks from a major surgical procedure and at least 2 weeks from an exploration/biopsy)
- •Discontinued from any other investigational drug for at least 30 days
- •Serum calcium <11 mg/dL
- •Absolute neutrophil count (ANC) ≥1,500/mm3, without growth factor support
- •Hemoglobin ≥9.0 g/dL
- •Platelet count ≥100,000/mm3
- •Serum creatinine ≤1.5 times the upper limit of normal (ULN)
- •Bilirubin ≤1.5 times ULN
- •ALT and AST ≤3 times ULN
- •Amylase and lipase ≤ ULN
- •PT and PTT < 1.5 times ULN
- •ECG with no acute abnormalities
- •Afebrile (≤37.5C or 99.5F)
- •Willingness and ability to comply with all study requirements
排除标准
- •Subject is mentally or legally incapacitated, or has significant emotional or psychiatric problems.
- •Concomitant primary malignant and/or non-malignant liver disease (primary liver cancer, acute or chronic hepatitis, cirrhosis, alcoholic liver disease).
- •History of pancreatic disease (e.g., pancreatitis, pancreatic malignancy).
- •New York Heart Association classification Class III or IV
- •Uncontrolled intercurrent illnesses including but not limited to: hypertension, seizure disorder, renal, gastrointestinal, or hematological diseases.
- •Clinically relevant systemic disease (other than the malignancy and malignancy-related hepatic dysfunction) making implementation of the protocol or interpretation of the study results difficult.
- •Pregnant or nursing, or unwilling to or will not agree to use an effective and reliable contraceptive measure.
- •Subject has received radiation to >25% of the total bone marrow.
- •Subject has a history of any other illness that would preclude study participation.
- •Subject has brain metastases.
- •Subject has allergy to egg yolk.
- •Subject receiving low-molecular weight heparin for treatment of a blood coagulation disorder (e.g., deep vein thrombosis, pulmonary embolism).