Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Partial Response in Bone Scan From Baseline to Week 6
研究概览
简要总结
Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.
详细描述
Cabozantinib will be taken by mouth daily. The first five treatment cycles will be 21 days. All cycles after that will be 42 days long. Patients will keep a diary to record study drug dosing.
During the screening phase patients will receive a physical exam, blood and urine tests, a bone scan, a CT of the abdomen and pelvis, and an MRI scan of total body. On Day 1 of each cycle patients will receive a physical exam and blood and urine tests. Bone scan, CT and MRI scans will be performed at the start of cycles 3 and 5, and then repeated once every 12 weeks.
Patients will continue to receive study treatment as long as they are receiving benefit from the treatment, do not experience any severe or unmanageable side effects, and disease does not get any worse.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate adenocarcinoma
- •Bone metastases confirmed by bone scan
- •Current androgen deprivation therapy
- •Castration-resistant disease based on progression in bone and/or PSA progression
- •Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events
- •Life expectancy of greater than 3 months
- •Normal organ and marrow function
- •Capable of understanding and complying with the protocol requirements
- •Agree to use medically accepted methods of contraception
- •Able to swallow capsules
排除标准
- •More than two prior chemotherapy regimens for metastatic prostate cancer
- •Known untreated, symptomatic or uncontrolled brain metastases
- •Serious or unhealed wound
- •Treatment with anticoagulants
- •Previously identified allergy or hypersensitivity to components of the study treatment formulation
- •History of a different malignancy unless disease-free for at least 5 years, or basal or squamous cell carcinoma of the skin
- •Current antiretroviral therapy
- •Uncontrolled hypertension
- •Uncontrolled intercurrent illness
研究组 & 干预措施
Cohort 1
Dose level 0: cabozantinib 40 mg daily
干预措施: cabozantinib (Drug)
Cohort 2
Dose level -1: cabozantinib 20 mg daily
干预措施: cabozantinib (Drug)
Expansion cohort
Dose level 0: cabozantinib 40 mg daily
干预措施: cabozantinib (Drug)
结局指标
主要结局
Partial Response in Bone Scan From Baseline to Week 6
时间窗: Baseline and Week 6
Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.
次要结局
未报告次要终点
研究者
Matthew R. Smith, MD, PhD
Professor of Medicine
Massachusetts General Hospital