NCT00060710终止2 期
Phase II Study of CP-461 in the Treatment of Patients With Advanced Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the efficacy of CP-461 given twice daily orally in patients with advanced or metastatic malignant melanoma and to evaluate the safety profile of CP-461 in this patient population.
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
- •Histologically confirmed malignant melanoma that is advanced or metastatic.
- •Patients may have received up to 2 prior systemic chemotherapy regimens (including dacarbazine, and alternative dosing schedule of temozolomide). The last chemotherapy must have been at least 4 weeks prior to study drug administration.
- •Prior radiation therapy will be allowed. Radiotherapy must have been completed at least 4 weeks prior to study drug administration.
- •Patients may have received prior surgery. At least 4 weeks must have elapsed and patients must have recovered from all side effects associated with surgery.
- •Patients with measurable disease. At least one bidimensionally measurable lesion with clearly defined margins documented by: medical photograph for skin and oral lesions, plain X-ray with at least one diameter 0.5 cm or greater, CT, MRI, or palpation with both diameters 2 cm or greater. A radiated bony lesion may not be considered an evaluable lesion, unless there is evidence of disease progression at that site prior to administration of study drug.
- •Clinical parameters: Life expectancy > 2 months, Age >18 years, ECOG performance status 0-2
- •Patients should have adequate organ function related to the following: White count > 3000/ul, Platelet count > 70,000/ul, Hemoglobin > 8 g/l, Bilirubin WNL, AST and ALT < 2.5 x ULN, and Creatinine < 1.5 x ULN or 24 hour creatinine clearance > 60 ml/min
- •There should be no acute infection requiring systemic antibiotics.
- •Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
排除标准
- •Subjects who have brain metastases.
- •More than 2 prior chemotherapy regimens for the treatment of advanced melanoma.
- •Chemotherapy within four weeks prior to study drug administration.
- •Radiation therapy to greater than or equal to 50% of the bone marrow. Patients must not have had prior radiotherapy to areas of measurable disease unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.
- •Insufficient recovery from all active toxicities of prior therapies.
- •Subjects who are poor medical risks because of active nonmalignant systemic disease.
- •Frequent vomiting or medical condition that could interfere with oral medication intake (e.g. partial bowel obstruction).
- •No prior malignancy other than curatively treated carcinoma in-situ of the cervix or skin cancer. If in the opinion of the treating physician, sufficient time has elapsed, such that it is extremely likely that the patient has been cured of a prior malignancy, the patient may be eligible for the protocol.
- •No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g. serious infection). HIV status or other severe illnesses will be assessed using medical records.
- •Pregnant or nursing women. Both women and men must take adequate precautions to prevent pregnancy during treatment.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study of CP-461 in Patients With Advanced Renal Cell CancerRenal Cell CarcinomaNCT00036036Astellas Pharma Inc14
已完成
2 期
CP-461 for the Treatment of Crohn's DiseaseCrohn's DiseaseNCT00042055Astellas Pharma Inc30
终止
2 期
CPX-351 Therapy for MDS After Hypomethylating Agent FailureMyelodysplastic Syndrome (MDS)NCT03957876Case Comprehensive Cancer Center4
撤回
2 期
A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's DiseaseDementiaAlzheimer's DiseaseDimebonInvestigational DrugNCT01066481Pfizer
已完成
2 期
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or HemodiafiltrationChronic Renal FailureNCT02331680Otsuka Pharmaceutical Co., Ltd.124