A Phase II Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Women With Breast Cancer and Established Bone Metastases (MBD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
研究概览
简要总结
This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases. This study will enroll approximately 45 women. The primary hypotheses are: (1) odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen (u-NTx) similar to that achieved with an intravenous (IV) infusion of zoledronic acid (ZA) over 4 weeks of treatment; and (2) odanacatib (MK-0822) will be safe and well tolerated during 4 weeks of treatment.
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
- Double (Participant, Investigator)
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
- •Patient has histologically or cytologically-confirmed breast cancer
- •Patient has documented skeletal metastases
排除标准
- •Patient is undergoing current oral bisphosphonate therapy, or has a history of oral bisphosphonate use within 6 months of entry into study
研究组 & 干预措施
Single IV infusion of ZA 4 mg
Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
干预措施: ZA (Drug)
Single IV infusion of ZA 4 mg
Participants will receive a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.
干预措施: Odanacatib matching placebo (Drug)
Odanacatib 5 mg
Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
干预措施: Odanacatib (Drug)
Odanacatib 5 mg
Participants will receive a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.
干预措施: ZA matching placebo (Drug)
结局指标
主要结局
Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4
时间窗: Baseline and Week 4
u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: Up to 6 weeks
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Number of Participants Who Discontinued Treatment Due to an AE
时间窗: Up to 4 weeks
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
次要结局
- Percentage Change From Baseline in Urinary Deoxypyridinoline (u-DPD) at Week 4(Baseline and Week 4)