EUCTR2010-023382-22-NL进行中（未招募）不适用
Phase I/II, multi-center, open label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASP9521 in patients with metastatic castrate-resistant prostate cancer - PHASE I/II STUDY OF ASP9521 IN CRPC PATIENTS
Astellas Pharma Europe B.V. (APEB)0 个研究点目标入组 186 人开始时间: 2011年7月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •A patient is eligible for the study if all of the following apply:
- •1.Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations must be obtained from the patient or legally authorized representative prior to any study-related procedures.
- •2.Male aged 18 years or older. Female sexual partners of male participants in the study must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies. Adequate contraceptive methods are defined as: sexual abstinence from the day of partner’s dosing until 3 months after the last dose; the use of a condom in addition to having their partner use another acceptable method (oral or injectable hormonal contraceptives, contraceptive patch, intra-uterine devices, vaginal hormonal rings, or sterilization by surgery, a vaginal diaphragm or cervical caps) during the study and for up to 3 months after the last dose; patient’s sexual partner is of non-child bearing potential i.e., post-menopausal, surgically sterilized (e.g., tubal ligation), or hysterectomy in medical history.
- •3.Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
- •4.Metastatic disease documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
- •5.Ongoing androgen deprivation with LHRH agonist/antagonist therapy or bilateral orchiectomy. For patients who have not had an orchiectomy, there must be a plan to maintain effective LHRH agonist/antagonist therapy for the duration of the study.
- •6.Serum testosterone <1.7 nmol/L (50 ng/dL) at screening.
- •7.Patients receiving bisphosphonates or other approved bone targeting therapy must have been on stable doses for at least 4 weeks prior to screening.
- •8.Progressive disease at study entry defined as one or more of the following 3 criteria occurring in the setting of castrate levels of testosterone:
- •?PSA progression defined by a minimum of 2 rising PSA levels with an interval of >1 week between each determination. The PSA value at screening should be >2 ng/mL.
- •?Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is not required for entry. Lymph nodes >20 mm are considered measurable disease.
- •?Bone disease progression defined by at least 2 new lesions on bone scan.
- •9.Life expectancy of >6 months according to the investigator’s judgment.
- •The following inclusion criteria must be fulfilled by chemotherapy-naïve patients:
- •10.Eastern Cooperative Oncology Group (ECOG) scores of 0 to 1.
- •11.Asymptomatic or controlled symptomatic patients with metastatic CRPC who have failed one or more lines of hormonal treatment/androgen deprivation therapy but have not received chemotherapy or have refused chemotherapy.
- •12.No prior chemotherapy for prostate cancer.
- •13.Anti-androgen withdrawal patients receiving an anti androgen as part of primary androgen ablation must demonstrate disease progression following discontinuation of anti-androgen (>4 weeks since last flutamide dose or >6 weeks since last bicalutamide or nilutamide dose).
- •The following inclusion criteria must be fulfilled by post chemotherapy patients:
- •14.ECOG scores of 0 to 2.
- •15.No more than 2 prior regimens of chemotherapy for prostate cancer, of which one is docetaxel-based to have been received at least 4 weeks prior
排除标准
- •Patients will be excluded from participation in the study if any of the following apply:
- •1.Concomitant treatment with the following is prohibited according to stratification as chemotherapy-naïve or post-chemotherapy patients:
- •?Chemotherapy-naïve patients:
- •?All chemotherapeutic agents.
- •?All biologic agents (except for sipuleucel T [Provenge®]), or other agents with anti-tumor activity against prostate cancer, including 5 alpha reductase inhibitors, androgens (e.g., testosterone), cytoproterone acetate and all other progestational agents, estrogens, and flutamide within 4 weeks prior to day of first dose of ASP9521.
- •?Bicalutamide or nilutamide within 6 weeks prior to day of first dose of ASP9521.
- •?Treatment with estramustine.
- •?Ketoconazole for treatment of prostate cancer.
- •?Treatment with abiraterone.
- •?Post-chemotherapy patients:
- •?All biologic agents (except for sipuleucel T [Provenge®]), or other agents with anti-tumor activity against prostate cancer, including 5 alpha reductase inhibitors, androgens (e.g., testosterone), progestational agents, estrogens, flutamide within 4 weeks prior to day of first dose of ASP9521.
- •?Bicalutamide or nilutamide within 6 weeks prior to day of first dose of ASP9521.
- •?Ketoconazole for treatment of prostate cancer.
- •?Treatment with abiraterone.
- •2.Use of herbal products that may have hormonal anti prostate cancer activity and/or are known to decrease PSA levels or Prednisolone > 10 mg (or an equivalent) for the treatment of prostate cancer within 4 weeks of day of first dose of ASP9521, or plans to initiate the above within the study period.
- •3.Radiation therapy for treatment of the prostate within 3 months prior to screening.
- •4.Radiation therapy for the treatment of metastases within 3 weeks (if single fraction of radiotherapy then within 2 weeks) and radionuclide therapy for the treatment of metastases within 4 weeks prior to screening.
- •5.Major surgery within 2 months prior to screening.
- •6.Known or suspected intracerebral disease or brain metastasis.
- •7.History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer.
- •8.Gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease).
- •9.Any of the following significant ophthalmological abnormalities:
- •a.Abnormal intraocular pressure (IOP).
- •b.Abnormal fundus, like age-related macular degeneration (AMD) or other retinal damage
- •10.Significant cardiovascular disease including:
- •?Myocardial infarction within 6 months prior to screening.
- •?Uncontrolled angina within 3 months prior to screening.
- •?Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is =45%.
- •?History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- •?History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place.
- •?Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) >170 mmHg or diastolic BP >105 mmHg at screening.
- •11.Concurrent disease or any clinically significant abnormality following the investigator’s review of the pre-study physical examination, 12-lead
研究者
相似试验
进行中（未招募）
1 期
Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) PatientsEUCTR2010-023382-22-BEAstellas Pharma Europe B.V. (APEB)186
进行中（未招募）
不适用
Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patientsmetastatic castrate-resistant prostate cancerMedDRA version: 14.1Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023382-22-GBAstellas Pharma Europe B.V. (APEB)186
进行中（未招募）
不适用
Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patientsmetastatic castrate-resistant prostate cancerMedDRA version: 14.1Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023382-22-DEAstellas Pharma Europe B.V. (APEB)186
撤回
2 期
Phase I/II, multi-center, open label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASP9521 in patients with metastatic castrate-resistant prostate cancerprostate carcinoma1002765510036958Prostate cancerNL-OMON38103Astellas Pharma20
招募中
1 期
Phase I/II, open-label, multi-center study to evaluate the safety and efficacy of glyco-humanized polyclonal antibody directed against tumoral T cells, in patients with relapsed/refractory peripheral T cells lymphoma (PTCL).Peripheral T cells lymphoma (PTCL)MedDRA version: 20.0Level: PTClassification code: 10042971Term: T-cell lymphoma Class: 100000004864CTIS2023-509648-88-00Xenothera15