NL-OMON54510招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer - SPARTA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 35
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. Criterion modified per amendment. 1.2 Histologically or cytologically
- •confirmed adenocarcinoma of the prostate without neuroendocrine differentiation
- •or small cell features, with high risk for development of metastases, defined
- •as PSADT <= 10 months. PSADT is calculated using at least 3 PSA values obtained
- •during continuous ADT. (see Section 5.1). 2. Criterion modified per amendment
- •2.1 Castration-resistant prostate cancer demonstrated during continuous ADT,
- •defined as 3 PSA rises at least 1 week apart, with the last PSA > 2 ng/mL 3.
- •Criterion modified per amendment 3.1. Criterion modified per amendment 3.2
- •Surgically or medically castrated, with testosterone levels of <50 ng/dL. If
- •the patient is medically castrated, continuous dosing with GnRHa must have been
- •initiated at least 4 weeks prior to randomization and must be continued
- •throughout the study to maintain castrate levels of testosterone. 4. Criterion
- •modified per amendment 4.1 Patients receiving bone loss prevention treatment
- •with bone-sparing agents indicated for the treatment of osteoporosis at doses
- •and dosing schedule appropriate for the treatment of osteoporosis (e.g.,
- •denosumab [Prolia®], zoledronic acid [Reclast®]) must be on stable doses for at
- •least 4 weeks prior to randomization. 5. Criterion modified per amendment 5.2
- •Patients who received a first generation anti-androgen (e.g., bicalutamide,
- •flutamide, nilutamide) must have at least a 4-week washout prior to
- •randomization AND must show continuing disease (PSA) progression (an increase
- •in PSA) after washout. 6. Criterion modified per amendment 6.2 At least 4 weeks
- •must have elapsed from the use of 5-a reductase inhibitors (e.g., dutasteride,
- •finasteride), estrogens (irrespective of dose used), and any other anti-cancer
- •therapy prior to randomization, including chemotherapy given in the
- •adjuvant/neoadjuvant setting (e.g., clinical trial) 7. At least 4 weeks must
- •have elapsed from major surgery or radiation therapy prior to randomization 8.
- •Age >= 18 years 9. Eastern Cooperative Oncology Group (ECOG) Performance Status
- •grade 0 or 1 10. Resolution of all acute toxic effects of prior therapy or
- •surgical procedure to Grade 1 or baseline prior to randomization 11. Criterion
- •modified per amendment 11.1 Criterion modified per amendment 11.2 Adequate
- •organ function as defined by the following criteria: * Serum aspartate
- •transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum
- •alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) <= 2.5 x
- •upper limit of normal (ULN) * Total serum bilirubin <=1.5 x ULN. Total serum
- •bilirubin >1.5 x ULN is allowed if Gilbert*s disease is documented prior to
- •screening. * Serum creatinine <= 2 x ULN * Absolute neutrophil count (ANC) >=
- •1500/µL * Platelets >= 100,000/µL * Hemoglobin >= 9.0 g/dL o Administration of
- •growth factors or blood transfusions will not be allowed within 4 weeks of the
- •hematology labs required to confirm eligibility 12. Signed and dated informed
- •consent document indicating that the patient (or legally acceptable
- •representative) has been informed of all pertinent aspects of the trial prior
- •to randomization 13. Criterion modified per amendment 13.1 Willingness and
- •ability to comply with scheduled visits, treatment plans, laboratory and
- •radiographic assessmen
排除标准
- •1. Criterion modified per amendment 1.1 Presence of distant metastases
- •confirmed by blinded independent central review (BICR), including CNS and
- •vertebral or meningeal involvement, or history of distant metastases.
- •Exception: Pelvic lymph nodes <2 cm in short axis (N1) located below the
- •iliac bifurcation are allowed 2. Symptomatic loco-regional disease requiring
- •medical intervention, such as moderate or severe urinary obstruction or
- •hydronephrosis, due to primary tumor (e.g., tumor obstruction of bladder
- •trigone) 3. Prior treatment with second generation anti-androgens (e.g.,
- •enzalutamide) 4. Criterion modified per amendment 4.1 Prior treatment with
- •CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galerterone,
- •ketoconazole, aminoglutethimide) 5. Prior treatment with radiopharmaceutical
- •agents (e.g., Strontium-89), immunotherapy (e.g., sipuleucel-T), or any other
- •investigational agent for NM-CRPC 6. Prior chemotherapy for prostate cancer,
- •except if administered in the adjuvant/neoadjuvant setting 7. History of
- •seizure or condition that may pre-dispose to seizure (e.g., prior stroke within
- •1 year prior to randomization, brain arteriovenous malformation, Schwannoma,
- •meningioma, or other benign CNS or meningeal disease which may require
- •treatment with surgery or radiation therapy) 8. Criterion modified per
- •amendment 8.1 Criterion modified per amendment 8.2 Concurrent therapy with any
- •of the following (all must have been discontinued or substituted for at least 4
- •weeks prior to randomization): * Medications known to lower the seizure
- •threshold (for a complete list please see Appendix 5) * Herbal (i.e., saw
- •palmetto) and non-herbal products (i.e., pomegranate) that may decrease PSA
- •levels * Systemic (oral/IV/IM) corticosteroids. Short term use (<= 4 weeks) of
- •corticosteroids during the study is allowed if clinically indicated, but it
- •should be tapered off as soon as possible * Any other experimental treatment on
- •another clinical trial * Agents indicated for the prevention of
- •skeletal-related events in patients with solid tumors (e.g., denosumab
- •[Xgeva®]) 9. Criterion modified per amendment 9.1 Criterion modified per
- •amendment 9.2 History or evidence of any of the following conditions: - Any
- •prior malignancy (other than adequately treated basal cell or squamous cell
- •skin cancer, superficial bladder cancer, or any other cancer in situ currently
- •in complete remission) within 5 years prior to randomization * Any of the
- •following within 6 months prior to randomization:Severe/unstable angina,
- •myocardial infarction, symptomatic congestive heart failure, arterial or venous
- •thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident
- •including transient ischemic attacks), or clinically significant ventricular
- •arrhythmias - Uncontrolled hypertension (systolic blood pressure >=160 mmHg or
- •diastolic BP >=100 mmHg). Patients with a history of uncontrolled hypertension
- •are allowed provided blood pressure is controlled by anti-hypertensive
- •treatment. -Gastrointestinal disorder affecting absorption -Active infection,
- •such as human immunodeficiency virus (HIV) - Any other condition that, in the
- •opinion of the Investigator, would impair the patient*s ability to comply with
- •study procedures.
研究者
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