A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC

NCT04102124 | Terminated Phase 2 DMC

• 1 other identifier: SHR3680-SHR3162-II-CRPC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's overall survival (OS) is superior to placebo.

Conditions

Prostate Cancer; Castration-resistant Prostate Cancer

Keywords

Castration-resistant Prostate Cancer; SHR3680; SHR3162

Outcome Measures

Primary Outcomes (2)

• Adverse Event(AE)

  The type, frequency, severity, timing, seriousness, and relationship to study therapy

  Approximately 70 months

• Overall Survival(OS)

  Time from randomisation to death due to any cause

  Approximately 70 months

Secondary Outcomes (8)

• Time to prostate specific antigen (PSA) progression

  Approximately 70 months

• Radiographic Progression Free Survival(rPFS)

  Approximately 70 months

• Objective response rate (ORR)

  Approximately 70 months

• Time to skeletal-related events

  Approximately 70 months

• PSA response rate

  Approximately 70 months

Study Arms (3)

SHR3680+SHR3162

EXPERIMENTAL

Participants will receive SHR3680 combined with SHR3162 orally

Drug: SHR3680; Drug: SHR3162

SHR3680+SHR3162(Placebo)

EXPERIMENTAL

Participants will receive SHR3680 combined with SHR3162(Placebo) orally

Drug: SHR3680; Drug: SHR3162(Placebo)

SHR3680(Placebo)+SHR3162(Placebo)

PLACEBO COMPARATOR

Participants will receive SHR3680(Placebo) combined with SHR3162(Placebo) orally

Drug: SHR3680(Placebo); Drug: SHR3162(Placebo)

Interventions

SHR3680 DRUG

Tablet. Specifications of 80mg

SHR3680+SHR3162; SHR3680+SHR3162(Placebo)

SHR3162 DRUG

Tablet. Specifications of 10mg、40mg、50mg and 100mg

SHR3680+SHR3162

SHR3680(Placebo) DRUG

Tablet. Specifications of 80mg

SHR3680(Placebo)+SHR3162(Placebo)

SHR3162(Placebo) DRUG

Tablet. Specifications of 10mg、40mg、50mg and 100mg

SHR3680(Placebo)+SHR3162(Placebo); SHR3680+SHR3162(Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed prostate cancer; does not suggest neuroendocrine or small cell characteristics
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
• Radiographic evidence of metastasis;
• 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;
• Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
• Adequate hepatic, renal, heart, and hematological functions;
• 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 patient at any time without prejudice to future medical care.
• Patient has been treated with Abiraterone and treatment failed（Treatment failure is defined as the progression of disease during treatment）
• Patient has been treated with Docetaxel and treatment failed or can not tolerate docetaxel chemotherapy or patients who are not suitable for docetaxel treatment at the time of screening.

You may not qualify if:

• Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
• Planned to initiate any other anti-tumor therapies during the study;
• Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
• Clinically significant cardiovascular diseases;
• History of seizure or certain conditions that may predispose to seizure;
• Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Ye Dingwei

Shanghai, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: April 8, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)