NCT00306631已完成2 期
A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Antitumor activity, based on the objective response rate
研究概览
简要总结
This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.
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 advanced or metastatic adenocarcinoma of the breast
- •18 years or older
- •Karnofsky performance status greater than or equal to 70%
- •Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Must have failed both a taxane and an anthracycline, given sequentially or in combination, either in an adjuvant or metastatic setting
- •All acute toxicity of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade less than or equal to 1
- •Lab results, within 10 days of MKC-1 administration:
- •Hemoglobin less than or equal to 9 g/dL
- •Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
- •Platelet count greater than or equal to 75 x 10^9/L
- •Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
- •AST less than or equal to 2.5 x ULN
- •Serum albumin greater than or equal to LLN (lower limit of normal)
- •Total bilirubin less than or equal to ULN
- •Alkaline phosphatase less than or equal to 2.5 x ULN
- •Signed informed consent
排除标准
- •Pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below the costal margin, secondary to malignancy
- •Administration of cancer specific therapy within the following periods prior to study drug initiation:
- •chemotherapy less than 3 weeks prior
- •hormonal therapy less than one week prior
- •radiation therapy less than 2 weeks prior
- •Be pregnant or lactating; not employing effective birth control
- •Known central nervous system (CNS) metastases unless treated, clinically stable and not requiring steroids
- •Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy
- •Administration of any investigational agent (therapeutic or diagnostic) within 4 weeks prior to receipt of study medication
- •Uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL)
- •Serious cardiac condition
- •Any medical conditions that, in the investigator's opinion would impose excessive risk to the patient
- •Patients with previous malignancies unless free of recurrence for at least 5 years except basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix
- •Treatment with antiretroviral therapy metabolized through CYP3A4
研究组 & 干预措施
1
Experimental
干预措施: MKC-1 (Drug)
结局指标
主要结局
Antitumor activity, based on the objective response rate
时间窗: every 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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