NCT00148707已完成2 期
Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.
研究概览
简要总结
The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.
详细描述
- Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
- Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
- Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
- Additional blood work will be performed once per week after the first two doses of CT-2103.
- The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.
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 or cytologically confirmed diagnosis of invasive breast cancer, Stage IV disease
- •Age greater than 18 years
- •At least one measurable target lesion as defined by RECIST that has not been previously treated with local therapy
- •HER2-negative breast cancer
- •Up to one prior chemotherapy for advanced or metastatic disease
- •ECOG performance status 0-1
- •Life expectancy > 12 weeks
- •Adequate liver and bone marrow function: AST < 2.5 x ULN; Bilirubin < 1.5 x ULN; ANC > 1,500/ul; platelet count > 100,000/ul; normal PT and PTT
- •At least 2 weeks since prior radiation and recovered from treatment-related toxicity
排除标准
- •Prior taxanes for treatment of metastatic disease
- •Pregnant of breast-feeding women
- •HER2-positive breast cancer
- •More than 1 prior chemotherapy regimen for metastatic disease
- •Untreated brain metastases
- •Concurrent radiotherapy or investigational drug
- •Prior bone marrow or stem cell transplant
- •History of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer
- •Uncontrolled infection
- •Active bleeding, or history of bleeding requiring transfusion
- •Active cardiac disease
- •Serious medical or psychiatric illness
结局指标
主要结局
To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.
次要结局
- To evaluate the side effects of CT-2103 in patients with metastatic breast cancer
- to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months
- to determine the time to progression and overall survival of patients treated with CT2103.
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal CancerRecurrent Ovarian CarcinomaPrimary Peritoneal CarcinomaNCT00045682Gynecologic Oncology Group78
已完成
2 期
Dose-finding Study of MT-1303Relapsing-remitting Multiple SclerosisNCT01742052Mitsubishi Tanabe Pharma Corporation415
已完成
2 期
Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's DiseaseCrohn's DiseaseNCT02378688Mitsubishi Tanabe Pharma Corporation78
已完成
2 期
Trial of Cetuximab in Patients With Metastatic and/or Locally Advanced Soft Tissue and Bony SarcomasSarcomaNCT00148109University of Michigan Rogel Cancer Center36
终止
2 期
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus PlaceboGastrointestinal CancerGenital Neoplasms, FemaleProstate CancerNCT00332280Auron Healthcare GmbH67