A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• ECOG performance scale 0 - 1.

• Life expectancy of more than 6 months.

• Histologically or cytologic confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features

• Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy

• Evidence of prostate cancer progression by radiographic or PSA criteria

• Radiological evidence of distant metastatic lesions

• Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the screening visit

• Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 10e9/L, neutrophil > 1.5 × 10e9/L, Hb >90 g/L,total bilirubin and creatinine within upper limit of normal(ULN), and serum transaminase≤1.5×the ULN).

• Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

• Treatment with androgen receptor antagonists, 5-alpha reductase inhibitors, estrogens, or chemotherapy within 4 weeks of enrollment or plans to initiate treatment with any of these drugs during the study

• Prior treatment with enzalutamide, abiraterone, or ketoconazole for prostate cancer

• History of seizure or any conditions that may predispose to seizure

• Concurrent or planned treatment with corticosteroids, medications known to have seizure potential, or herbal products known to decrease PSA levels

• Planned to initiate any other anti-tumor therapies during the study

• Less than 4 weeks from the last clinical trial

• Evidence of brain metastasis or primary tumors

• Clinically significant cardiovascular diseases

• Abuse of alcohol or drugs

• Severe concurrent disease, infection, or bone metastasis that, in the judgment of the investigator, would make the patient inappropriate for enrollment