AzTrials
AzTrials

Prostate Cancer MetastaticPhase 2NCT04603833

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

A Phase 2 study testing SHR3680+Docetaxel, SHR3680 and Docetaxel in people with Prostate Cancer Metastatic, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The aim of this trial is to evaluate SHR3680 combined with Docetaxel to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's Time to prostate specific antigen (PSA) progression is superior to SHR3680 or Docetaxel single drug. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
SHR3680+Docetaxel, SHR3680 and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
2 Dec 2020to 31 Dec 2022
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; Unconfirmed neuroendocrine carcinoma or small cell carcinoma;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
  • Radiographic evidence of metastasis（CT/MRI/ECT);
  • 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;
Show all 9Show fewer
  • 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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care；
  • Expected to survive for at least 3 months；
  • Patient has been treated with Abiraterone and treatment failed；Treatment failure is defined as the progression of disease during treatment；

Who cannot join

  • Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
  • As a subject to participate in other drug clinical trials, the last test drug was administered within 4 weeks from the first dose of the study drug;
  • Plan to receive any other anti-tumor treatment during this trial;
  • Subjects have contraindications to prednisone, such as active infections or other conditions;
  • Subjects present any chronic condition requiring treatment with corticosteroids at doses greater than prednisone 5 mg, BID;
  • The investigators judged severe bone damage caused by tumor bone metastasis, including severely controlled bone pain, pathological fractures and spinal cord compressions that occurred in the last 6 months or are expected to occur in the near future;
Show all 15Show fewer
  • Uncontrolled high blood pressure (systolic blood pressure 160 mmHg or diastolic blood pressure 95 mmHg). If blood pressure can be effectively controlled by antihypertensive therapy, subjects with a history of hypertension are allowed to participate in the study;
  • Study of active heart disease within 6 months prior to the first dose, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction <50%, and room for medication Arrhythmia;
  • Imaging diagnosis of brain tumor lesions;
  • history of pituitary or adrenal dysfunction;
  • Study of other malignant tumors within 5 years prior to the first dose (in situ cancer with complete remission and excluding malignant tumors with slow progress);
  • Patients with active HBV or HCV infection (HBV virus copy number #104 copies/mL, HCV virus copy number #103 copies/mL), or active syphilis infection;
  • History of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency disease) or organ transplant history;
  • Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before the first dose;
  • Patients who are unwilling to take effective contraceptive measures during the entire study period and within 3 months after the last dose

Trial locations and contacts

1 site in 1 country.

Chunlei Jin, Ph.D. contact

86-021-23511999

jinchunlei@hrglobe.cn

Qiang Wei, Ph.D. contact

028-85423237

China1 site, 1 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Qiang Wei, Ph.D.

    Recruiting

Other trials in China

About this study

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

The aim of this trial is to evaluate SHR3680 combined with Docetaxel to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's Time to prostate specific antigen (PSA) progression is superior to SHR3680 or Docetaxel single drug.

Being tested
SHR3680+Docetaxel, SHR3680, Docetaxel

What participants receive

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

  • SHR3680+DocetaxelDrug

    Participants will receive SHR3680 combined with Docetaxel

  • SHR3680Drug

    Participants will receive SHR3680

  • DocetaxelDrug

    Participants will receive Docetaxel

Study groups in NCT04603833
Study groupRoleWhat they receive
SHR3680+DocetaxelExperimentalNot described
Receives: Drug: SHR3680+Docetaxel
SHR3680Active comparatorNot described
Receives: Drug: SHR3680
DocetaxelActive comparatorNot described
Receives: Drug: Docetaxel

What is being measured

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

  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: [Time Frame: Approximately 24 months]

  2. Adverse Event(AE)

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

    Measured: [Time Frame: Approximately 24 months]

Secondary outcomes (7)

  1. Radiographic Progression Free Survival(rPFS)

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

    Measured: [Time Frame: Approximately 24 months]

  2. 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: [Time Frame: Approximately 24 months]

  3. 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: [Time Frame: Approximately 3 months]

  4. Overall Survival(OS)

    Time from randomisation to death due to any cause

    Measured: [Time Frame: Approximately 24 months]

  5. Area Under the Curve (AUC)

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

    Measured: [Time Frame: Approximately 2 months]

  6. Maximum Observed Plasma Concentration (Cmax)

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

    Measured: [Time Frame: Approximately 2 months]

  7. Minimum Observed Plasma Concentration (Cmin)

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

    Measured: [Time Frame: Approximately 2 months]

Timeline

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

  1. First posted27 Oct 2020
  2. Study start2 Dec 2020
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

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
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603833
Sponsor's protocol ID
SHR3680-II-203
Status last verified
Oct 2020
First submitted
22 Oct 2020
Last updated
21 Feb 2021
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+Docetaxel, SHR3680 and Docetaxel in people with Prostate Cancer Metastatic, 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 15 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. 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. 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?

Results are not available in the source record.

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

Contact Chunlei Jin, Ph.D. (86-021-23511999, jinchunlei@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to prostate specific antigen (PSA) progression (time frame: [Time Frame: Approximately 24 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 NCT04603833.

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 21 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in