EUCTR2015-003741-26-BE进行中（未招募）1 期
A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-5829 as a Single Agent and In Combination with Enzalutamide in Subjects with Metastatic Castrate-Resistant Prostate Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
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
- •Subjects must meet all of the following inclusion criteria to be
- •eligible for participation in this study:
- •Male aged 18 years and older
- •Histologically or cytologically confirmed prostate cancer (subjects with primary neuroendocrine carcinoma of prostate are excluded)
- •Phase 1b Monotherapy Dose Escalation: Subject must have documented progressive disease by meeting at least one of the PCWG2 criteria despite treatment with abiraterone and/or enzalutamide
- •Phase 1b Combination Therapy Escalation and Phase 2 Dose Expansion (Group 2): Subjects must have documented progressive disease by meeting at least one of the PCWG2 criteria, despite treatment with abiraterone. They may not have received prior enzalutamide or chemotherapy for mCRPC
- •Phase 2 Monotherapy Dose Expansion (Group 1): Subjects must have documented progressive disease by meeting at least one of the PCWG2 criteria, despite treatment with enzalutamide. They may have received prior abiraterone, but not prior chemotherapy, for mCRPC
- •Phase 2 Combination Therapy Dose Expansion (Group 3): Subjects must have documented progressive disease by meeting the PCWG2 criteria for PSA progression, but not radiographic progression, despite treatment with enzaluatimide. They may have received prior abiraterone, bit not prior chemotherapy, for mCRPC (similar to Group 1); however they must also have been on continuous enzalutamide therapy for at least 12 weeks prior to Cycle 1, Day 1
- •Castration-resistant disease defined as ongoing androgen deprivation therapy with GnRH analogue or bilateral orchiectomy and serum testosterone level = 1.73 nmol/L (50 ng/dL) at the screening visit. Subjects who have not had a bilateral orchiectomy must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial
- •Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT/MRI. Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible
- •All acute toxic effects of any prior antitumor therapy resolved to Grade = 1 before the start of study drug dosing (with the exception of alopecia [Grade 1 or 2 permitted] and neurotoxicity [Grade 1 or 2 permitted])
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1
- •Life expectancy of = 3 months, in the opinion of the Investigator
- •Adequate organ function defined as follows: a) Hematologic: Platelets = 100 x 109/L; Hemoglobin = 9.0 g/dL; ANC = 1.5 x 109/L (without platelet transfusion or any growth factors within previous 7 days of the hematologic laboratory values obtained at screening visit); b) Hepatic: AST / ALT = 2.5 x upper limit of normal (ULN) (if liver metastases are present, = 5 x ULN); total or conjugated bilirubin = 1.5 x ULN; c) Renal: Serum Creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 60 mL/min as calculated by the Cockroft-Gault method
- •Coagulation: International Normalized Ratio (INR) = 1.2
- •Male subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception and refrain from sperm donation for at least 90 days
- •Able and willing to provide written informed consent to participate in the study
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- •History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion
- •Known brain metastasis or leptomeningeal disease
- •Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, active or chronic bleeding event within 28 days prior to first dose of study drug, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
- •A history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident and brain arteriovenous malformation are excluded from combination therapy with enzalutamide
- •Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of Cycle 1 Day 1
- •Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first dose of study drug
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of GS-5829, including any unresolved nausea, vomiting, or diarrhea that is Common Terminology Criteria for adverse Events (CTCAE) Grade > 1
- •Minor surgical procedure(s) within 7 days of enrollment or randomization, or not yet recovered from prior surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent = 1 day before enrollment or randomization is acceptable)
- •Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 21 days or 5 half-lives, whichever is longer, of study drug dosing (6 weeks for nitrosoureas, mitomycin C, or molecular agents with t1/2 > 10 days); concurrent use of an LHRH agonist is permitted for all subjects and ongoing enzalutamide is required in group 3
- •History of a concurrent or second malignancy, except for: adequately treated local basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; breast carcinoma in situ; adequately treated Stage 1 or 2 cancer currently in complete remission; any other cancer that has been in complete remission for = 5 years
- •History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (> 450 ms). Subjects who screen fail due to this criterion are not eligible to be re-screened
- •Prior exposure to bromodomain (BET) inhibitors
- •Clinically significant bleeding within 28 days of Cycle 1 Day 1
- •Known human immunodeficiency virus (HIV) infection
- •HBsAg positive
- •HCV antibody positive
- •Use of moderate/strong cytochrome P450 (CYP)3A4 inhibitors or moderate/strong CYP3A4 inducers within 2 weeks prior to the firs
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