EUCTR2013-003865-32-ES进行中（未招募）不适用
A Pharmacokinetic and Pharmacodynamic Translational Investigation of Galeterone in Patients with Metastatic Castration Resistant Prostate Cancer - A Phase 2 Study of the Pharmacokinetics and Pharmacodynamics of galeterone for treatment of CRPC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
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. Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
- •2. Male age ? 18 years
- •3. Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology)
- •4. Ongoing androgen blockade (therapy with gonadotropin-releasing hormone (GnRH) analogues, or orchiectomy) demonstrated by serum testosterone concentration of less than 50 ng/dL
- •5. Demonstration of progression while on androgen blockade (based upon PCWG2 guidelines).
- •? Patients must have PSA levels that have risen on at least two successive occasions, at least 1 week apart, with the most recent PSA level ?2 ng/mL with or without the following:
- •a. Nodal spread with no evidence of bone or visceral disease
- •b. Bone disease with or without nodal disease and no evidence of visceral spread
- •c. Visceral metastases with or without nodal or bone disease
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status ?2
- •7. Life expectancy of > 12 weeks
- •8. Able to swallow multiple tablets whole without crunching or breaking
- •9. Must have tumor deposits accessible for biopsy
- •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 14
排除标准
- •1. Participation in another clinical trial involving experimental therapy < 4 weeks prior to enrollment.
- •2. The following medications :
- •a. Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone)
- •* In some cases of prior ketoconazole treatment, patients may be allowed to participate based upon discussion of the individual details between the PI and the Tokai Medical Representative.
- •b. Prior treatment of CRPC with chemotherapy agents (including but not limited to taxanes, anthracyclines, mitoxantrone, platinators, etc.)
- •c. Treatment with non-steroidal oral antiandrogens (e.g. flutamide, bicalutamide or nilutamide), 5-alpha reductase inhibitors, (e.g. dutasteride, finasteride) within 4 weeks of enrollment
- •Note: Patients must show a continued rise in PSA (two consecutive measures at least 2 weeks apart) after the cessation of these therapies
- •d. Use of herbal products that may decrease PSA levels (e.g., saw palmetto) within 4 weeks of enrollment or plans to initiate treatment with any of these herbal products during the trial
- •e. Prior use of any chronic systemic glucocorticoids within the last 6 months (short course use at Tokai Medical Representative discretion) or plans to initiate treatment with chronic systemic glucocorticoids during the trial
- •f. Prior external beam radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks)
- •g. Prior treatment with radium 223-dichloride (Xofigo®) or any other therapeutic radionuclide
- •h. Treatment with anti arrhythmia therapy for ventricular arrhythmia ? 4 weeks prior to enrollment
- •i. Treatment with Coumadin® (warfarin sodium) or other anti-coagulant therapy (except aspirin) ? 4 weeks prior to enrollment
- •j. Ongoing treatment or plans to initiate treatment with spironolactone
- •3. The following laboratory findings:
- •a. Testosterone >50 ng/dL
- •b. Measured or calculated creatinine clearance ?50 ml/min (CKD-EPI calculation method)
- •c. Bilirubin > 2.5x the ULN
- •d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 5x the ULN
- •e. Hemoglobin ? 9.0 g/dL
- •f. Absolute neutrophil count (ANC) ? 1.5 x 109/L
- •g. Platelets ? 100 x 109/L
- •h. Serum potassium (K+) < 3.5 mmol/L
- •4. 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 enrollment)
- •c. Atrial fibrillation
- •d. History of chronic or active Hepatitis B or Hepatitis C or other known chronic liver disease (Note: Positive findings on the hepatitis panel will be reviewed by the Tokai Medical Representative to determine eligibility)
- •e. Known human immunodeficiency virus (HIV) infection
- •f. Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure of > 100 mmHg measured on at least two occasions, two weeks apart) despite acceptable anti-hypertension therapy
- •g. History of adrenal insufficiency or hyperaldosteronism
- •h. Gastrointestinal disorders or gastric bypass surgery including lap bands that could interfere with the absorption of galeterone
- •i. Serious active infections requiring systemic treatment or nonmalignant medical illnesses that are uncontrolled
- •j. Any history of (in the past 5 years) second malignancy, other than treated non melanoma skin cancer and superficial transitional cell carcinoma of the bladder
- •k. Active or uncontrolled autoimmune disease
- •l. Active biliar
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