NCT00047788已完成2 期
A Phase Two Study of ZD6474 in Patients With Relapsed Multiple Myeloma
Genzyme, a Sanofi Company7 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2002年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
研究概览
简要总结
The primary objective is to assess the efficacy of ZD6474 when given orally to patients with relapsed multiple myeloma. A minimum of 15 and a maximum of 30 evaluable patients will be entered on study
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
- •Confirmed diagnosis of multiple myeloma.
- •Patients must have a minimum serum M-protein level >=10g/L on serum protein electrophoresis or for patients with light chain only disease, a minimum Bence-Jones protein of 1g/24 hr.
- •Patients must have received prior treatment for multiple myeloma: patients may have received 1 or 2 prior regimens of oral alkylating based chemotherapy and must have relapsed following treatment (>= 3 months) OR patients may have relapsed following high dose chemotherapy and SCT as first line treatment provided they have not had any other treatment.
- •Lab at inclusion of AGC >= 1.0 x10_9/L and platelets >= 50 x10_9/L Bilirubin, AST and/or ALT <= 1.5 x UNL; creatinine < 2 x UNL, Potassium >= 4.0 mmol/L; calcium and magnesium within normal limits·
- •Patients may not have had > 2 prior regimens of chemotherapy and/or prior thalidomide treatment.
- •Patients may not have had any non-alkylating based chemotherapy.
排除标准
- •Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >= 5 years.
- •Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to registration and must be using effective contraception throughout the study.
- •Patients who have relapsed during treatment with oral alkylating chemotherapy.
- •Patients who have received more than 2 prior regimens of chemotherapy.
- •Patients who have received excluded medication or have excluded medical conditions.
- •Patients who have received any non-alkylating based chemotherapy regimens as initial therapy, or as therapy for recurrent disease.
研究者
研究点 (7)
Loading locations...
相似试验
已完成
2 期
Phase II Study of Best Support Care (BSC) Plus ZD6474(Vandetanib) in Patients With Inoperable Hepatocellular Carcinoma (HCC)Carcinoma, HepatocellularNCT00508001Genzyme, a Sanofi Company67
已完成
2 期
Phase II Study of Vandetanib in Individuals With Kidney CancerRenal CancerVon Hippel LindauNCT00566995National Cancer Institute (NCI)37
终止
1 期
Radiation Therapy (XRT) and ZD6474 in Non-Small Cell Lung Cancer (NSCLC)Non-Small Cell Lung CancerNCT00745732M.D. Anderson Cancer Center3
已完成
2 期
AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic LeukemiaB-cell Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaNCT00321724National Cancer Institute (NCI)35
已完成
1 期
ZD6474 to Treat Advanced Brain Cancer in PatientsRecurrent High-Grade GliomasProgressive Low-Grade GliomasMalignant GliomasNCT00272350National Cancer Institute (NCI)83