EUCTR2012-001961-33-ES进行中（未招募）不适用
A phase I/II, multicenter, open-label dose finding study of oral CFG920 in patients with metastatic castration-resistant prostate cancer
ovartis Farmacéutica S.A.0 个研究点目标入组 100 人开始时间: 2012年10月29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
- 100
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
- •1. Age > 18 years
- •2. Eastern Cooperative Oncology Group (ECOG) performance status grade 0-1
- •3. Suitable venous access for blood sampling
- •4. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma 5. Documented metastases determined by bone scan, CT-scan, or MRI
- •6. Documented ongoing castration condition defined by a serum testosterone levels of < 50 ng/dl (1.7 nmol/L).
- •7. Documented progressive disease, defined as per the PCWG2 guidelines
- •8. Minimum washout period of 4 weeks after the use of prostate cancer therapy and 6 weeks after stopping the antiandrogens bicalutamide and MDV3100
- •9. Anticoagulation is allowed if patients are already on a stable dose of warfarin or low molecular weight heparin for > 2 weeks at time of dose initiation
- •10. Concomitant use of bisphosphonates is allowed if the dose and renal function have been stable for at least 12 weeks before the enrollment
- •11. Laboratory values specified in the protocol
- •12. Patient is capable of understanding and complying with the protocol and has signed the informed consent document prior to the start of screening
- •Phase I only
- •13. Patients must have progressed on, are intolerant to, or have refused abiraterone acetate AND have progressed on, are intolerant to, or refused docetaxel
- •Phase II only
- •14. Patients must have progressed on, are intolerant to, or have refused docetaxel
- •Phase I/II abiraterone naïve patients
- •15. No prior treatment with CYP17 inhibitors or MDV3100
- •Phase I/II primary abiraterone-resistant CRPC
- •16. Disease progression while on continuous treatment with ABI or progression up to 30 days after the last dose of ABI
- •17. No intervening systemic therapy between cessation of ABI and initiation of CFG920 treatment
- •18. Patient has not demonstrated objective clinical benefit while on continuous treatment with ABI
- •Phase I/II secondary abiraterone-resistant CRPC
- •19. Disease progression while on continuous treatment with ABI or progression up to 30 days after the last dose of ABI
- •20. No intervening systemic therapy between cessation of ABI and initiation of CFG920 treatment
- •21. Patient demonstrated objective clinical benefit while on continuous treatment with ABI
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease
- •2. Major surgery within 28 days before study treatment and/or have not recovered fully from the adverse effects of any major surgical procedures before study treatment
- •3. Patients who have received radiotherapy ? 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •4. Chronic steroid therapy other than the following: Daily use of 10 mg prednisone or low dose steroid for the control of nausea and vomiting, topical steroid, or inhaled steroid use.
- •5. Participation in another clinical trial involving experimental therapy < 4 weeks prior to the first dose of study drug or ongoing in another experimental trial related to the treatment of prostate cancer
- •6. Current evidence of spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction
- •7. History of another primary malignancy that is currently clinically significant or currently requires active intervention
- •8. Uncontrolled hypertension despite appropriate medical therapy
- •9. History of pituitary or adrenal dysfunction
- •10. Gastrointestinal disorders or gastric by-pass surgery that could interfere with the swallowing and absorption of CFG920
- •11. Impaired cardiac function or clinically significant cardiac disease
- •12. History of an active infection requiring systemic therapy within 10 days before study treatment.
- •13. Known diagnosis of human immunodeficiency virus (HIV) infection
- •14. Evidence of active hepatitis viral infection such as hepatitis B or hepatitis C or chronic liver disease
- •15. Patients who are currently receiving prohibited medications listed in the protocol and cannot be discontinued at least 1 week prior to starting CFG920
- •16. Any condition that in the assessment of the investigator renders the patient not suitable for participation in this clinical study protocol
研究者
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