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 - 9521-CL-0002 (798/118)

Astellas Pharma0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方: Astellas Pharma
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•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 bisphosphonate 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 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. Antiandrogen 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 administered at least 4 weeks prior to screening.

排除标准

•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.
•* Treatment with estramustine.
•* Bicalutamide or nilutamide within 6 weeks prior to day of first dose of ASP9521.
•* 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 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 ECG and clinical la

研究者

发起方

Astellas Pharma

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