A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

• Status: Terminated
• Trial end date: 2020-12-08
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.

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

Details

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

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed prostate cancer;

2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;

3. Radiographic evidence of metastasis;

4. Sustained therapy of luteinizing hormone-releasing hormone analogue（LHRHA）or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;

5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;

6. Adequate hepatic, renal, heart, and hematological functions;

7. Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy;

2. Planned to initiate any other anti-tumor therapies during the study;

3. Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;

4. Clinically significant cardiovascular diseases;

5. History of seizure or certain conditions that may predispose to seizure;

6. Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.