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

Primary Purpose

Prostate Cancer, Castration-resistant Prostate Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

SHR3680

SHR3162

SHR3680(Placebo)

SHR3162(Placebo)

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Castration-resistant Prostate Cancer, SHR3680, SHR3162

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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.

Exclusion Criteria:

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.

Sites / Locations

Ye Dingwei

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

SHR3680+SHR3162

SHR3680+SHR3162(Placebo)

SHR3680(Placebo)+SHR3162(Placebo)

Arm Description

Participants will receive SHR3680 combined with SHR3162 orally

Participants will receive SHR3680 combined with SHR3162(Placebo) orally

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

Outcomes

Primary Outcome Measures

Adverse Event(AE)

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

Overall Survival(OS)

Time from randomisation to death due to any cause

Secondary Outcome Measures

Time to prostate specific antigen (PSA) progression

Time from randomisation to the first time of PSA progression according to the criterion of PCGW3

Radiographic Progression Free Survival(rPFS)

Time from randomisation to radiologically confirmed progressive disease or death due to any cause

Objective response rate (ORR)

The percentage of patients with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

Time to skeletal-related events

Time from randomisation to the first occurrence of a skeletal-related event. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery.

PSA response rate

After the continuous therapy from randomisation to the end of the 12 weeks, the percentage of patients whose levels of PSA decreased by more than 50% compared with baseline.

Area Under the Curve (AUC)

The single dose and multiple dose PK will be calculated as data permits including AUC

Maximum Observed Plasma Concentration (Cmax)

The single-dose and multiple dose PK will be calculated as data permits including Cmax

Minimum Observed Plasma Concentration (Cmin)

The single-dose and multiple dose PK will be calculated as data permits including Cmin

Full Information

NCT ID

NCT04102124

First Posted

September 23, 2019

Last Updated

May 12, 2020

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04102124

Brief Title

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

Official Title

A Phase II Clinical Study of SHR3680 Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer Previously Treated With Abiraterone and Docetaxel

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 8, 2019 (Actual)

Primary Completion Date

November 1, 2021 (Anticipated)

Study Completion Date

November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is a multicenter, randomized , double-blind Phase II trial and the aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients Previously Treated With Abiraterone and Docetaxel whether the patient's overall survival (OS) is superior to placebo. The Stage I part is a dose-escalation and -expansion study. Approximately 18~24 patients in Stage I will receive fixed-dose of orally SHR3680 and only one of two dose levels of orally SHR3162. The Primary endpoints of the Stage I are incidence of adverse events(AE) and recommended phase 2 dose(RP2D). The Stage II part is a randomized , double-blind study. Approximately 90~120 patients in Stage II will receive SHR3162 combined with SHR3680, in which one fixed-dose levels of SHR3162 will be selected based on the result of the Stage I.The Primary endpoint of the Stage II is overall survival(OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Castration-resistant Prostate Cancer

Keywords

Castration-resistant Prostate Cancer, SHR3680, SHR3162

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR3680+SHR3162

Arm Type

Experimental

Arm Description

Participants will receive SHR3680 combined with SHR3162 orally

Arm Title

SHR3680+SHR3162(Placebo)

Arm Type

Experimental

Arm Description

Participants will receive SHR3680 combined with SHR3162(Placebo) orally

Arm Title

SHR3680(Placebo)+SHR3162(Placebo)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SHR3680

Intervention Description

Tablet. Specifications of 80mg

Intervention Type

Drug

Intervention Name(s)

SHR3162

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SHR3680(Placebo)

Intervention Description

Tablet. Specifications of 80mg

Intervention Type

Drug

Intervention Name(s)

SHR3162(Placebo)

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse Event(AE)

Description

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

Time Frame

Approximately 70 months

Title

Overall Survival(OS)

Description

Time from randomisation to death due to any cause

Time Frame

Approximately 70 months

Secondary Outcome Measure Information:

Title

Time to prostate specific antigen (PSA) progression

Description

Time from randomisation to the first time of PSA progression according to the criterion of PCGW3

Time Frame

Approximately 70 months

Title

Radiographic Progression Free Survival(rPFS)

Description

Time from randomisation to radiologically confirmed progressive disease or death due to any cause

Time Frame

Approximately 70 months

Title

Objective response rate (ORR)

Description

Time Frame

Approximately 70 months

Title

Time to skeletal-related events

Description

Time Frame

Approximately 70 months

Title

PSA response rate

Description

After the continuous therapy from randomisation to the end of the 12 weeks, the percentage of patients whose levels of PSA decreased by more than 50% compared with baseline.

Time Frame

Approximately 70 months

Title

Area Under the Curve (AUC)

Description

The single dose and multiple dose PK will be calculated as data permits including AUC

Time Frame

Approximately 12 months

Title

Maximum Observed Plasma Concentration (Cmax)

Description

The single-dose and multiple dose PK will be calculated as data permits including Cmax

Time Frame

Approximately 12 months

Title

Minimum Observed Plasma Concentration (Cmin)

Description

The single-dose and multiple dose PK will be calculated as data permits including Cmin

Time Frame

Approximately 12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Ye Dingwei

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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