BKM120+Abiraterone Acetate for Metastatic CRPC
Phase Ib Study of BKM120 Combined With Abiraterone Acetate for Docetaxel-pretreated, Castrate-resistant, Metastatic Prostate Cancer
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and taht research doctors are trying to find out more about it. It also means that the FDA has not approved the drug for use in patients, including people with your type of cancer.
BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to better outcomes in many types of cancer.
Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone acetate, individuals must also take a glucocorticoid such as prednisone.
Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel, after which treatment with the combination of abiraterone and prednisone has been shown to be effective. Evidence has shown an interaction between the pathways through which BKM120 and abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The purpose of this study is to determine a safe dose for the combination of daily oral BKM120, abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate cancer who have received prior treatment with docetaxel.
研究概览
详细说明
You will undergo a screening process to determine if you are eligible to participate in this trial. This process will include the following procedures: Tumor Biopsy, including a bone marrow biopsy, which is used to determine the kinds of cancer cells in your tumor and a Physical Examination, including weight, blood pressure, heart rate, respiratory rate and body temperature.
Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have docetaxel resistant CRPC, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. There will be a 14 day lead in phase of BKM120 alone to assess for toxicity from this agent. After the lead in phase, the standard dose of abiraterone and prednisone will be added to the BKM120 treatment regimen. Treatment cycles will last 4 weeks (28 days), during which time you will be taking the study drug in combination with the standard drug therapy once daily. Your time of participation in the study will be based on how well you tolerate the experimental drug. You could be participating in the study for a period of days, or years, depending on the course of your cancer.
During each treatment cycle, you will be required to return to see your research doctor for a study visit on Day 1 of each cycle. For Cycle 1, you will also need to return on Days 8, 15 and 22.
The following procedures will be performed and samples will be collected at 1 or more study visits: Evaluation of side effects, Vital sign measurement, Heart function tests, Neuropsychologic exams, Performance status assessment, Tumor biopsy, Assessment of tumor, Blood samples.
We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year will help us look at the long-term effects of the research study. You will be required to return to see your research doctor for an end of study visit, which will take place 4-8 weeks after you undergo prostatectomy.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
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Boston、Massachusetts、美国、02115
- Beth-Israel Deaconess Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically or cytologically confirmed CRPC with metastatic bone disease
- Castrate resistant disease
- Life expectancy of at least 6 months
- At least four weeks from previous treatment
- At least four weeks since any major surgery or radiation therapy
- Using highly effective contraception
Exclusion Criteria:
- Thromboembolism within past 6 months
- History of diabetes
- Prior therapy with abiraterone
- Prior therapy with PI3K inhibitor
- Alcohol or drug dependence currently or within past 6 months
- Contraindications to biopsy, such as bleeding disorders
- On anticoagulants such as warfarin or heparin
- Active malignancy other than skin cancer or superficial bladder cancer
- Untreated brain metastases
- Acute or chronic liver, renal disease or pancreatitis
- Mood disorders judged by the investigator to interfere with study participation
- Active cardiac disease or history of cardiac dysfunction
- Uncontrolled hypertension
- Known HIV, Hepatitis B or C
- Serious non-healing wound, ulcer or bone fracture
- Known or suspected allergy to BKM120, abiraterone or prednisone
- Impairment of GI function
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment Arm
BKM120+Abiraterone+Prednisone
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Orally, every morning
Orally, 1000 mg, every morning
Orally, 5 mg, every morning
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety Profile and MTD for BKM120/Abiraterone/Prednisone
大体时间:2 years
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Determine the safety profile and MTD for the combination of BKM120 and abiraterone plus prednisone
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Duration of Response in Expansion Cohort
大体时间:2 years
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Determine duration time of response (time to progression) in the expansion cohort
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2 years
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Impact of PTEN Status on Response Rate/Duration
大体时间:2 years
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Assess the impact of PTEN status on response rate and duration of response
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2 years
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
BKM120的临床试验
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Novartis Pharmaceuticals完全的