EUCTR2014-005079-10-GB进行中（未招募）1 期
ARMOR3-SV: A Phase 3, Randomized, Open-Label, Multi-Center, Controlled Study of Galeterone Compared with Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA with Metastatic Castration Resistant Prostate Cancer - ARMOR3-SV
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
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, sarcomatoid or squamous 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 by the treating physician at study entry (baseline) despite castrate serum testosterone, as defined as 1 or more of the following 3 criteria:
- •a. PSA progression defined by a minimum of 2 rising PSA levels measured at least 1 week apart. Patients who received anti-androgen treatment must have PSA progression after withdrawal (= 2 weeks since last flutamide, bicalutamide or nilutamide). PSA at Screening should be = 2 µg/L (2 ng/mL);
- •b. Bone disease progression based on PCWG2 criteria defined by the presence of 2 or more new lesions on bone scan;
- •c. Soft tissue or visceral disease progression based on 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 baseline central radiologic review. Per the American Joint Committee on Cancer (7th edition), M1 disease includes visceral/bony disease outside the true pelvis or pathologic (short axis lesion diameter =1.5cm) nodal involvement above the aortic bifurcation. Patients with evaluable disease limited to regional pelvic lymph nodes that reside anywhere within the pelvic inlet to the inguinal canals are not eligible;
- •9) Asymptomatic or mildly symptomatic pain due to prostate cancer (ie, the score on the BPI-SF Question #3 must be < 4) with or without the use of concomitant pain medication
- •10) Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
- •11) 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);
- •12) Able to swallow up to six pills and retain oral medication;
- •13) Expected life expectancy of = 6 months;
- •14) 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 128
排除标准
- •1)Participation in another clinical trial involving experimental therapy for CRPC within 4 weeks prior to first dose of study drug 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
- •b.Prior treatment with second generation anti-androgens
- •c.Treatment with first generation anti-androgens within 2 weeks prior to first dose of study drug;
- •d.Prior treatment with CYP17 inhibitors
- •e.Ketoconazole use =2 weeks prior to first dose of study drug;
- •f.Prior radiation therapy (single fraction or radionuclide therapy [ß or ? emitters]) within 2 weeks of first dose of study drug;
- •g. Prior treatment of bone metastases with radium Ra-223 dichloride (Xofigo®) (a emitters) = 4 weeks prior to first dose of study drug. Treatment or plans to initiate treatment during the trial are prohibited;
- •h. Prior treatment with cytotoxic chemotherapy for CRPC, except patients may have received docetaxel for metastatic hormone sensitive prostate cancer; those patients must demonstrate continued disease progression and must not have received chemotherapy for at least 4 weeks prior to first dose of study drug;
- •i. Prior treatment with sipuleucel-T or other investigational cancer immunotherapy is allowed provided that the treatment has been completed = 4 weeks prior to first dose of study drug, 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 ; patients must be on a stable dose for at least 4 weeks prior to first dose of study drug;
- •4)Treatment with 5-alpha reductase inhibitors or estrogens = 4 weeks prior to first dose of study drug;
- •5) Major surgery within 4 weeks prior to first dose of study drug;
- •6) Any use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 2 weeks of first dose of study drug;
- •7)The following laboratory findings:
- •a)Testosterone >50ng/dL
- •b)PSA <2 µg/L (2ng/mL)
- •c)Serum creatinine >2 times ULN
- •d)Bilirubin = 1.5 times institutional ULN
- •e)Aspartate aminotransferase and/or alanine aminotransferase >2.5 times the ULN
- •f)Hemoglobin <9.0g/dL
- •g) Absolute neutrophil count <1.5x109/L
- •h) Platelets < 75 x 109/L;
- •i) Serum potassium (K+) <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 first dose of study drug);
- •c)History of clinically significant ventricular arrhythmia
- •d)History of long QT syndrome, Mobitz II 2nd or 3rd degree heart block without a permanent p
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