A Pharmacodynamic Study Using NaF PET/CT Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Metastatic Castrate Resistant Prostate Cancer to Bone
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values
研究概览
简要总结
The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, TAK-700.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 18 years or older
- •Voluntary written consent
- •Histologically proven adenocarcinoma of the prostate
- •Evidence of radiographic bone metastases
- •May have received prior chemotherapy for metastatic disease, but prior chemotherapy is not a requirement for eligibility
- •Eastern Cooperative Oncology Group performance status 0-2
- •Serum testosterone level is less than or equal to 50 ng/dL
- •Has undergone orchiectomy or plan to continue receiving gonadotropin releasing hormone (GnRH) analogue therapy
- •Adequate organ function as measured by screening laboratory values specified in the protocol
- •Must agree to use appropriate contraceptives prior to study procedures, during duration of study participation and for 4 months after last dose of TAK 700
- •Must be able to lie flat for greater than or equal to 30 minutes during PET/CT imaging
- •Screening calculated ejection fraction of greater than or equal to 50% by multigated radionuclide angiography (MUGA) scan or Echocardiogram
排除标准
- •Received Strontium-89, Samarium-153, or other radioisotope within 3 months of registration
- •history of allergic reactions attributed to compounds similar to sodium fluoride F-18 (NaF)
- •history of seizure disorder
- •Known history of brain metastases
- •Concurrent treatment with any herbal products within 7 days of study entry
- •Received radiotherapy less than or equal to 4 weeks prior to registration
- •Known hypersensitivity to TAK-700 or related compounds
- •Prior therapy for treatment of metastatic castrate resistant prostate cancer with any androgen biosynthesis inhibitor or androgen signaling pathway inhibitor such as: enzalutamide (MDV-3100), abiraterone, ketoconazole, or aminoglutethimide
- •Current bladder neck outlet obstruction
- •Current spinal cord compression
- •Current bilateral hydronephrosis
- •History of adrenal insufficiency
- •History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias (over grade 2), thromboembolic events, or any other cardiac condition within 6 months prior to first dose of study drug.
- •Uncontrolled high blood pressure
- •Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- •Major surgery less than or equal to 4 weeks before the first dose of study drug
- •Serious infection less than or equal to 2 weeks before the first dose of study drug
- •Known gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of TAK-700, including difficulty swallowing capsules
研究组 & 干预措施
TAK-700
TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
The most common way of assessing bone metastasis is planar bone scintigraphy or single photon emission computed tomography (SPECT), though both lack high spatial resolution and thus make small metastases detection inaccurate. Positron emission tomography (PET) is a successful imaging modality with a higher resolution than SPECT, but has not been widely adopted in bone imaging. One of the most promising PET imaging agents for detection of bone metastasis is 18F-Sodium Fluoride (Fluorine F 18 Sodium Fluoride, or NaF). NaF uptake is characterized by high and rapid bone uptake accompanied by very rapid blood clearance, which results in a high bone-to-background ration in a short time.
干预措施: TAK-700 (Drug)
TAK-700
TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
The most common way of assessing bone metastasis is planar bone scintigraphy or single photon emission computed tomography (SPECT), though both lack high spatial resolution and thus make small metastases detection inaccurate. Positron emission tomography (PET) is a successful imaging modality with a higher resolution than SPECT, but has not been widely adopted in bone imaging. One of the most promising PET imaging agents for detection of bone metastasis is 18F-Sodium Fluoride (Fluorine F 18 Sodium Fluoride, or NaF). NaF uptake is characterized by high and rapid bone uptake accompanied by very rapid blood clearance, which results in a high bone-to-background ration in a short time.
干预措施: Fluorine F 18 Sodium Fluoride (Radiation)
TAK-700
TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
The most common way of assessing bone metastasis is planar bone scintigraphy or single photon emission computed tomography (SPECT), though both lack high spatial resolution and thus make small metastases detection inaccurate. Positron emission tomography (PET) is a successful imaging modality with a higher resolution than SPECT, but has not been widely adopted in bone imaging. One of the most promising PET imaging agents for detection of bone metastasis is 18F-Sodium Fluoride (Fluorine F 18 Sodium Fluoride, or NaF). NaF uptake is characterized by high and rapid bone uptake accompanied by very rapid blood clearance, which results in a high bone-to-background ration in a short time.
干预措施: Positron Emission Tomography (Procedure)
TAK-700
TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
The most common way of assessing bone metastasis is planar bone scintigraphy or single photon emission computed tomography (SPECT), though both lack high spatial resolution and thus make small metastases detection inaccurate. Positron emission tomography (PET) is a successful imaging modality with a higher resolution than SPECT, but has not been widely adopted in bone imaging. One of the most promising PET imaging agents for detection of bone metastasis is 18F-Sodium Fluoride (Fluorine F 18 Sodium Fluoride, or NaF). NaF uptake is characterized by high and rapid bone uptake accompanied by very rapid blood clearance, which results in a high bone-to-background ration in a short time.
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values
时间窗: Baseline and 3 months
To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline.
Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate
时间窗: Baseline and 3 months
Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline.
Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values
时间窗: Baseline and 3 months
To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline.
次要结局
- Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700(Up to 12 months)
- Number of Participants With Changes in NaF PET/CT Results in Response to TAK700(At baseline and 12 weeks)
- Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment(Up to 14 months)
- Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival.(Approximately 24 months)
- Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)(At baseline and 12 weeks)
- PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results(Baseline, one month, 2 months, 3 months)
- Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles(At baseline, one month, three months)