EUCTR2012-001574-28-GB进行中（未招募）1 期
A Phase 2 Study of Hsp90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone
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
- 49
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 who meet all of the following criteria will be eligible to participate in the study:
- •1. Have a histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology;
- •Subjects who meet all of the following criteria will be eligible to participate in the study:
- •1. Have a histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology;
- •2. Have received prior castration by orchiectomy and/or LHRH agonist with or without antiandrogen and documented serum testosterone <50 ng/dL;
- •3. Males >18 years of age;
- •4. Have Eastern Cooperative Oncology Group (ECOG) performance Status =2;
- •5. Have not had androgen receptor (AR) antagonist treatment in the 6 weeks prior to the first dose of study drug;
- •6. Have been receiving abiraterone acetate therapy with a steroid for =1 month. Only subjects tolerating abiraterone acetate 1000 mg at screening will be eligible to participate in the study;
- •7. Have documented disease progression on abiraterone acetate defined by 1 or more of the following criteria:
- •PSA progression according to PCWG2 criteria with 3 consecutive rising PSA measurements, all collected at least 1 week apart;
- •Radiographic progression in soft tissue or bone by modified RECIST 1.1 for subjects with measurable disease; or
- •Bone disease progression defined by 2 or more new lesions on 2 consecutive bone scans in the absence of falling PSA;
- •8. Have CTC count >5 cells/7.5 mL at baseline (for Part A only);
- •9. Have adequate bone marrow function, defined as absolute neutrophil count >1.5 K/µL and platelet count >100 K/µL;
- •10. Have adequate hepatic function, defined as bilirubin =1.5 × ULN, ALT and aspartate transaminase (AST) =2.5 × ULN (ALT and AST =5 × ULN, if liver metastases are present);
- •11. Have adequate renal function, defined as creatinine =1.25 × ULN or creatinine clearance >50 mL/min;
- •12. Must be willing to provide pre-existing diagnostic or resected tumor samples, such as formalin-fixed, paraffin-embedded sections or slides, if this material exists. If pre-existing samples are not available, a sample must be obtained during screening;
- •13. Subjects and their female partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months following the last dose of study drug. Effective contraception includes methods such as oral contraceptives, double-barrier method (condom plus spermicide or diaphragm) or abstaining from sexual intercourse; and
- •14. Must be willing and able to provide written informed consent and comply with the protocol and study procedures.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 148
排除标准
- •Subjects who meet any of the following criteria will be excluded from the study:
- •1. Prior anti-cancer treatment with any HSP90 inhibitor or histone deacetylase (HDAC) inhibitor compound;
- •2. Have received chemotherapy within 4 weeks prior to the first dose of study drug;
- •3. Prior prostate surgery or radiotherapy within 4 weeks from the first dose of study drug and single fraction radiotherapy within 2 weeks prior to the first dose of study drug;
- •4. Hypersensitivity to AT13387 or other components of the drug product;
- •5. Treatment with any investigational drug within 4 weeks prior to the first dose of study drug;
- •6. Poor medical risk because of other systemic diseases or active uncontrolled infections;
- •7. Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors which, in the Investigator’s opinion, could compromise the subject’s safety, interfere with the metabolism of AT13387, or compromise the integrity of the study outcomes;
- •8. Abnormal LVEF (<50%) on echocardiogram (ECHO) or multigated acquisition (MUGA) scan; history of ischemic cardiac event, including myocardial infarction within 3 months of study entry, congestive cardiac failure of =Grade 3 severity according to New York Heart Association (NYHA) functional classification; history of long QTc syndrome or ventricular arrhythmias; or screening QTcF >450 msec after correction of any electrolyte imbalance and confirmation of QTc by triplicate measurement;
- •9. Prior malignancy except for adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder cancer, or other cancer from which the subject has been disease-free for at least 3 years;
- •10. Known symptomatic brain or CNS involvement such as a result of cord compression;
- •11. Contraindication to the use of corticosteroids or history of pituitary or adrenal dysfunction;
- •12. Prior dose reductions of abiraterone acetate as a result of increased transaminases; or
- •13. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus.
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