Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Participants With Bone Bio-marker Response
研究概览
简要总结
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved the drug for this type of cancer, or for any use outside of research studies.
When cancer spreads from the primary tumor, one of the most commons sites it spreads to is bone. When cancer spreads to bone there can be significant symptoms such as pain.
Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been studied or is being studied in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney cancer.
Previous clinical research studies indicate that cabozantinib may also have activity against cancer once it has spread to the bones.
The purpose of this study is to find out if cabozantinib is effective in treating cancer that has spread to the bone.
详细描述
Cabozantinib is a tablet that the subject will take by mouth. The subject will take it once per day. The study treatment with cabozantinib will be divided into 28 day cycles. A member of the study staff will give the subject a drug diary and explain to the subject how to use it to record doses of cabozantinib. This diary will also contain specific instructions about how the subject take cabozantinib.
Every 28 days the subject will undergo the following procedures: Physical examination, questions about any side effects the subject may have, blood samples for routine laboratory tests and research tests, urine sample, electrocardiogram (EKG), and questionnaires to measure quality of life and level of pain. Every two months the subject will undergo a CT scan or MRI to evaluate the subjects disease.
The investigators would like the subject to return to the study clinic for follow-up procedures about 4-5 weeks after the last dose of cabozantinib.
The subject can continue to receive the study drug for as long as their disease does not worsen and the subject do not experience unacceptable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologic or cytologic diagnosis of a solid tumor (not breast or prostate) that is metastatic and refractory to or progressed following standard therapies
- •Has bony metastases
- •Agree to use medically accepted methods of contraception
排除标准
- •Pregnant or breastfeeding
- •Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents within 3 weeks of study entry(6 weeks for nitrosoureas/mitomycin C)
- •Received radiation to the thoracic cavity/GI tract (within 3 months of study entry), to bone or brain metastasis (within 14 days) or to any other site within 28 days
- •Received prior treatment with small molecule kinase inhibitor or hormonal therapy within 14 days/5 half-lives
- •Received therapy with another investigational agent within past 28 days
- •Has not recovered from toxicities due to prior therapies
- •Primary brain tumor
- •Active brain metastases or epidural disease
- •Uncontrolled significant intercurrent or recent illness
- •Allergy or hypersensitivity to components of the study treatment formulation
研究组 & 干预措施
Treatment Arm
Cabozantinib
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Number of Participants With Bone Bio-marker Response
时间窗: 8 Weeks
Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.
次要结局
- Number of Patients With Skeletal-related Events (SRE)(2 years)
- Quality of Life as Assessed by FACT-G(From baseline to Cycle 3 Day 1 (approximately 2 months))
- Overall Tumor Response Rate(2 years)
- MET Amplification in Tumor Sample(2 years)
- Response to Cabozantinib in Bone Metastatic Disease(2 years)
- Time to SRE(2 years)
研究者
Rebecca Suk Heist, MD
Principal Investigator
Massachusetts General Hospital