A Study to Establish Proof-of-Biology for MK-0646 in Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)
研究概览
简要总结
A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
- •Participant is female and ≥18 years of age
排除标准
- •Participant is pregnant, breastfeeding or planning to become pregnant while in the study
- •Participant has received prior chemotherapy, biological therapy or radiation
- •Participant has participated in a clinical trial in the last 30 days
- •Participant has a history of drug or alcohol abuse in the last year
- •Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C
- •Participant has poorly controlled diabetes mellitus
研究组 & 干预措施
ER-positive Luminal B
Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.
干预措施: dalotuzumab (MK0646) (Drug)
Triple Negative
Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.
干预措施: dalotuzumab (MK0646) (Drug)
结局指标
主要结局
Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)
时间窗: Up to 12 Days Post-dose
GFS was measured by microarray analysis of the entire 101 gene signature expression. The GFS is quantified as the change in gene expression between two separate samples collected from the same participant. A log (base 10) ratio of expression in the post-dose sample was generated relative to the reference in both the Up and DOWN arms of the gene signature. A log ratio value of zero indicated no change in the expression between the two samples. GFS was calculated as the mean log ratio of genes in the UP arm minus mean log ratio of genes in the Down arm. GFS was compared for paired samples (pre-dose and post-dose) by a T-statistic calculated as the GFS divided by its standard error. Responders to therapy had a T-statistic that was smaller than the threshold 1st percentile of student's T-distribution and were counted as having a decrease in GFS.
次要结局
- Change From Baseline in IGF1R Membrane H-Score After a Single Dose of Dalotuzumab(Baseline and Up to 12 Days)
- Percentage of IGF1R Positive Participants With a Decrease in GFS by Cohort(Up to 12 Days Post-dose)
- Percentage of IGF1R Negative Participants With a Decrease in GFS by Cohort(Up to 12 Days Post-dose)