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Prostate CancerPhase 2NCT04102124

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

A Phase 2 study testing SHR3680 and SHR3162 in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
SHR3680 and SHR3162
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteChina
Study dates
8 Apr 2019to 31 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ye Dingwei

    Shanghai

Other trials in China

About this study

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

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.

Read the 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).

Being tested
SHR3680, SHR3162, SHR3680(Placebo), SHR3162(Placebo)
Keywords
Castration-resistant Prostate Cancer, SHR3680, SHR3162
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR3680Drug

    Tablet. Specifications of 80mg

  • SHR3162Drug

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

  • SHR3680(Placebo)Drug

    Tablet. Specifications of 80mg

  • SHR3162(Placebo)Drug

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

Study groups in NCT04102124
Study groupRoleWhat they receive
SHR3680+SHR3162ExperimentalParticipants will receive SHR3680 combined with SHR3162 orally
Receives: Drug: SHR3680; Drug: SHR3162
SHR3680+SHR3162(Placebo)ExperimentalParticipants will receive SHR3680 combined with SHR3162(Placebo) orally
Receives: Drug: SHR3680; Drug: SHR3162(Placebo)
SHR3680(Placebo)+SHR3162(Placebo)Placebo comparatorParticipants will receive SHR3680(Placebo) combined with SHR3162(Placebo) orally
Receives: Drug: SHR3680(Placebo); Drug: SHR3162(Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event(AE)

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

    Measured: Approximately 70 months

  2. Overall Survival(OS)

    Time from randomisation to death due to any cause

    Measured: Approximately 70 months

Secondary outcomes (8)

  1. Time to prostate specific antigen (PSA) progression

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

    Measured: Approximately 70 months

  2. Radiographic Progression Free Survival(rPFS)

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

    Measured: Approximately 70 months

  3. 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

    Measured: Approximately 70 months

  4. 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.

    Measured: Approximately 70 months

  5. 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.

    Measured: Approximately 70 months

  6. Area Under the Curve (AUC)

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

    Measured: Approximately 12 months

  7. Maximum Observed Plasma Concentration (Cmax)

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

    Measured: Approximately 12 months

  8. Minimum Observed Plasma Concentration (Cmin)

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

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start8 Apr 2019
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Why it stopped: The sponsor's R\&D strategy is adjusted.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102124
Sponsor's protocol ID
SHR3680-SHR3162-II-CRPC
Status last verified
Jun 2025
First submitted
23 Sep 2019
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR3680 and SHR3162 in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The sponsor's R\&D strategy is adjusted.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event(AE) (time frame: Approximately 70 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04102124.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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