Spots Global Cancer Trial Database for A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients
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Trial Identification
Brief Title: A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients
Official Title: A Phase I/II, Open-Label, Dose-Escalation and -Expansion, Safety, Pharmacokinetics and Efficacy Study of SHR3680 in Patients With Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT02691975
Interventions
Study Description
Brief Summary: This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will receive SHR3680.
Detailed Description: Androgenic signaling plays a pivotal role in the development of prostate cancer. Androgen deprivation therapy is the mainstay treatment for this cancer in the metastatic setting, but the disease eventually develops to castration-resistant prostate cancer (CRPC) mainly due to the overexpression of androgen receptors (AR) and continued AR activation. SHR3680 is a novel strong AR antagonist. By competitively binding to AR, SHR3680 inhibits androgen-mediated translocation of AR to the nucleus, binding of AR to Deoxyribonucleic acid (DNA), and finally the transcription of AR target genes, thus possibly resulting in a specific and strong anti-tumor effect on prostate cancer. Unlike first-generation AR antagonists (e.g. bicalutamide), which undergoes an antagonist-to-agonist switch to stimulate AR in the setting of AR overexpression in CRPC, SHR3680 is a full antagonist of AR and thus it is supposed to be more effective for the treatment of CRPC.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Beijing Hosptial, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
Henan Cancer Hospital, Zhenzhou, Henan, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Huadong Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Dingwei Ye, M.D.
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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