EUCTR2014-005079-10-ES进行中（未招募）1 期
ARMOR3-SV: A Phase 3, Randomized, Open-Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) with Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC) - ARMOR3-SV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 148
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 who meets all of the following inclusion criteria will be eligible to participate in this study:
- •1)Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits, and provide authorization for Sponsor use and release of health and research trial information;
- •2)Male age > 18 years;
- •3)Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate (excluding pure/predominant neuroendocrine differentiation or small cell histology);
- •4)Detectable AR-V7 mRNA transcript in CTCs as assessed by qRT-PCR performed at the central laboratory;
- •5)Castrate serum testosterone level: ? 50 ng/dL (1.73 nmol/L);
- •6)Bilateral orchiectomy (i.e., surgical castration) or ongoing androgen deprivation therapy (ADT) with a GnRH analogue or antagonist. Patients who have not had bilateral orchiectomy must maintain effective GnRH-analogue therapy for the duration of the trial;
- •7)Progressive disease confirmed at study entry (baseline) despite castrate serum testosterone, as defined as one or more of the following three criteria:
- •a)PSA progression defined by a minimum of two rising PSA levels measured at least 1 week apart. Patients who received anti-androgen must have progression after withdrawal (?4 weeks since last flutamide or ? 6 weeks since last bicalutamide or nilutamide). PSA at Screening should be ? 2 ?g/L (2 ng/mL);
- •b)Bone disease progression as determined by the central radiologic review based on PCWG2 criteria defined by the presence of two or more new lesions on bone scan;
- •c)Soft tissue or visceral disease progression as determined by the central radiologic review based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- •8)Metastatic disease documented by bone lesions on bone scan or by soft tissue disease documented by CT/MRI as determined by the central radiologic review. Patients whose disease spread is limited to regional pelvic lymph nodes that reside anywhere within the pelvic inlet to the inguinal canals are not eligible;
- •9)Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
- •10)If sexually active with a woman of child-bearing age, must be willing to use 2 forms of adequate contraceptive methods (i.e., barrier contraception with spermicide) and continue use for 90 days after discontinuing study drug treatment (galeterone or enzalutamide);
- •11)Able to swallow up to six pills and retain oral medication;
- •12)Expected life expectancy of ? 6 months;
- •13)Able to adhere to study visit schedule and all protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 126
排除标准
- •1)Participation in another clinical trial involving experimental therapy for CRPC within 4 weeks prior to randomization or simultaneous participation in a study involving investigational treatment
- •2)Prior anti-cancer therapy:
- •a.Prior treatment with galeterone or any other investigational agent for metastatic prostate cancer (eg ARN-509, ODM-201, TAK-385)b.Prior treatment with second generation anti-androgens (eg enzalutamide, ARN-509)c.Treatment with flutamide within 4 weeks prior to randomization or treatment with bicalutamide or nilutamide within 6 weeks prior to randomization
- •d.Prior treatment with CYP17 inhibitors (eg abiraterone)
- •e.Ketoconazole use ?4 weeks prior to randomization is excluded
- •f.Prior radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) or radionuclide therapy (? or ? emitters) within 8 weeks of randomization
- •g.Prior treatment of bone metastases with radium Ra-223 dichloride (Xofigo®) (? emitters) ? 4 weeks prior to randomization. Treatment or plans to initiate treatment during the trial are prohibited
- •h.Prior treatment with cytotoxic chemotherapy for CRPC, except patients may have received up to 6 cycles of docetaxel (75 mg/m2 per cycle) in combination with ADT for metastatic hormone sensitive prostate cancer (mHSPC); those patients must demonstrate continued disease progression (as determined by central radiologic review of baseline data based on PCWG2 and RECIST 1.1) and must not have received chemotherapy for at least 4 weeks prior to randomization
- •i.Pretreatment with sipuleucel-T or other investigational cancer immunotherapy is allowed provided that the treatment has been completed ? 30 days prior to randomization, but treatment or plans to initiate treatment during the trial is prohibited.
- •3)Concurrent use of other anti-cancer agents except for the following:
- •a.Ongoing treatment with luteinizing hormone-release hormone agonists/antagonists
- •b.Bone loss prevention therapy with bone-sparing agents (e.g., bisphosphonates, denosumab)
- •4)Treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) or estrogens ?4 weeks prior to randomization
- •5)Major surgery within 4 weeks prior to randomization
- •6)Any use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of randomization
- •7)The following laboratory findings:
- •a)Testosterone >50ng/dL
- •b)PSA <2 ?g/L (2ng/mL)
- •c)Serum creatinine >2 times ULN
- •d)Bilirubin ? 1.5 times ULN
- •e)Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 times the ULN
- •f)Hemoglobin <9.0g/dL
- •g)Absolute neutrophil count (ANC) <1.5x109/L
- •h)Platelets <100x109/L
- •i)Serum potassium <3.0mmol/L
- •j) Albumin<30 g/L
- •8)The following medical conditions:
- •a)New York Heart Association Class III or IV congestive heart failure
- •b)Myocardial infarction/unstable angina (within the 6 months prior to randomization)
- •c)History of clinically significant ventricular arrhythmias (eg ventricular tachycardia)
- •d)History of long QT syndrome, Mobitz II 2nd or 3rd degree heart block without a permanent pacemaker in place
- •e)Bradycardia as defined by heart rate of <50 beats/min at Screening ECG
- •f)History of chronic or active Hepatitis B or Hepatitis C or other known chronic liver disease. Patients recovered from hepatitis are not excluded from the study.
- •g)Known HIV infection
- •h)Uncontrolled hyper
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