NCT01046916已完成2 期
A Phase 2 Multicenter Open-label Study Evaluating the Safety and Efficacy of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer (CRPC) and a Rising Prostate-specific Antigen (PSA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment
研究概览
简要总结
This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).
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
- •Each patient must meet all of the following inclusion criteria:
- •Male patients 18 years or older
- •Eastern Cooperative Oncology Group performance status 0-2
- •Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse.
- •Voluntary written consent
- •Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone
- •Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months
- •Has undergone orchiectomy or will continue receiving GnRH analogue therapy
- •Meet screening laboratory values as specified in protocol
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- •Known hypersensitivity to TAK-700 or related compounds
- •Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids
- •Received prior therapy with aminoglutethimide or ketoconazole
- •Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug
- •Received prior chemotherapy for prostate cancer
- •Current bladder neck outlet obstruction caused by prostate cancer, current spinal cord compression, or current bilateral hydronephrosis
- •Symptoms that investigator deems related to prostate cancer
- •Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
- •History of adrenal insufficiency
- •Uncontrolled cardiovascular condition
- •Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- •Unwilling or unable to comply with protocol
- •Major surgery or serious infection within 14 days of first dose of TAK-700
- •Life-threatening illness unrelated to cancer
- •Uncontrolled nausea, vomiting or diarrhea
- •Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700
研究组 & 干预措施
TAK-700
Experimental
干预措施: TAK-700 (Drug)
结局指标
主要结局
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment
时间窗: 3 months
次要结局
- To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months(3 and 6 months)
- To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment(6 months)
- To determine time to PSA progression, time to metastases, and duration of progression-free survival(Evidence of PSA or disease progression)
- To monitor changes in endocrine markers(Evidence of PSA or disease progression)
- To evaluate the safety of TAK-700(Evidence of PSA or disease progression)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating MutationsAdvanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,BreastNCT04639219AstraZeneca102
已完成
2 期
A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal MelanomaMucosal MelanomaNCT05420324Eucure (Beijing) Biopharma Co., Ltd20
已完成
2 期
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial LinesUpper Facial Lines (Glabellar Lines, Forehead Lines, & Lateral Canthal Lines)NCT04259086Revance Therapeutics, Inc.48
已完成
2 期
A Study of Vemurafenib in Metastatic Melanoma Participants With Brain MetastasesMalignant MelanomaNCT01378975Hoffmann-La Roche146
终止
2 期
Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)Leukemia, Myeloid, AcuteNCT00129948SGX Pharmaceuticals, Inc.211