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Metastatic Castration-resistant Prostate CancerPhase 2NCT04676607

SHR7390 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

A Phase 2 study testing SHR7390 in people with Metastatic Castration-resistant Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial aims to prospectively assess the safety and efficiency of SHR7390 in metastatic castration-resistant prostate cancer Read more about this study

Who is it for?
Ages 18 to 120 years, men only
What is being tested?
SHR7390
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
17 Dec 2020to 12 Jun 2023
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 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-75 years，male
  • ECOG PS：0-1
  • Life expectancy of more than 6 months
  • After surgery or drug castration, testosterone level was < 50 ng / dl. For subject receiving LHRH agonist / antagonist therapy (patients without orchiectomy), the treatment must start at least 4 weeks before the first day of cycle 1 and must be continued throughout the study
  • Failure (radiological or PSA progression) or intolerance of at least one but not more than two taxanes based chemotherapy regimens and novel endocrine therapy (at least one of enzalutamide, apartamide, abitelone or shr3680). If docetaxel regimen used more than once, count as one regimen
  • Disease progressed within 6 months prior to inclusion in the study. Disease progression defined as the occurrence of one or more of the following three items at the same time of castration：
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  • ① PSA progression，defined as at least twice increases in PSA level (interval time ≥ 1 week, and PSA level at screening should be ≥ 2ng / ml)
  • ②Disease progression as defined in RECIST 1.1
  • ③Bone disease progression defined by PCWG3，more than 2 new lesions in bone scan
  • Metastatic lesions with radiologica evidence， measurable non-bone target lesions
  • Adequate hepatic, renal, heart, and hematologic functions (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before blood routine screening)：platelets>80×10^9/L，neutrophil>1.5×10^9/L, Hb≥90 g/L,total bilirubin≤1.5×limit of normal(ULN), ALT and AST ≤2.5×ULN（≤5×ULN with liver metastasis），blood urea nitrogen and creatinine≤1.5×ULN
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
  • Willing to participate in this clinical trial, understand the research procedures and have signed informed consent

Who cannot join

  • Prior treatment with MEK inhibitors，including trametinib
  • Washout period from the end of any previous anti-tumor treatment (including radiotherapy, chemotherapy, surgery, molecular targeted therapy, immunotherapy, androgen receptor inhibitors, CYP-17 inhibitors, 5 α-reductase inhibitors, estrogen, progesterone drugs, etc) to the first administration of the study drug less than 1 week (bicalutamide elution period < 2 weeks)
  • Plant drugs (e.g. Saw Palmetto) or steroids that may reduce PSA levels within 4 weeks, or planned to be used during the trial period (except for temporary steroid drugs for preventing or treating allergies)
  • Plan to receive any other anti-tumor treatment during this trial
  • Last drug administration from other clinical trials within 4 weeks
  • Radiological confirmed tumor foci in the brain
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  • Severe bone injury caused by tumor bone metastasis judged by researchers, including severe bone pain with poor control, pathological fracture of important parts and spinal cord compression occurred or expected to occur in recent 6 months
  • History of epilepsy, or the disease that can induce epilepsy within 12 months (including the history of transient ischemic attack, cerebral apoplexy (except for cerebral ischemic foci simply found by imaging examination), brain trauma with disturbance of consciousness and hospitalization）
  • Hypotension (systolic blood pressure < 86mmhg) or uncontrollable hypertension (systolic blood pressure ≥ 150mmhg or diastolic blood pressure ≥ 100mmhg) within 30 days. The blood pressure results were the average value of three consecutive measurements with an interval of more than 2 minutes
  • Active heart disease including severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring drug treatment within 6 months
  • Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors affecting drug administration and absorption
  • History of retinopathy confirmed by ophthalmic examination or neurosensory retinal detachment. Risk factors such as retinal vein thrombosis / occlusion (RVO), central serous retinopathy (CSR) or neovascular macular degeneration
  • IOP > 21mmhg or diagnosed with glaucoma within 4 weeks
  • Active HBV or HCV infection (HBV copies ≥ 10^4 copies / ml, HCV copies ≥ 10^3 copies/ml)
  • History of immunodeficiency (including HIV positive, other acquired and congenital immunodeficiency diseases) or organ transplantation history
  • Not willing to take effective contraceptive measures during the whole study period and within 6 months after the last administration
  • Any accompanying diseases (such as poorly controlled hypertension, severe diabetes, thyroid disease and psychosis) that seriously endanger the safety of patients or affect the patients to complete the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: SHR7390 in the Treatment of Metastatic Hormone-Resistant Prostate Cancer That Failed Previous Docetaxel and New Endocrine Therapy

This trial aims to prospectively assess the safety and efficiency of SHR7390 in metastatic castration-resistant prostate cancer

Being tested
SHR7390

What participants receive

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

  • SHR7390Drug

    SHR7390

Study groups in NCT04676607
Study groupRoleWhat they receive
treatment groupExperimentalSHR7390
Receives: Drug: SHR7390

What is being measured

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

  1. 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: 2 years

  2. AE

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

    Measured: 2 years

Secondary outcomes (6)

  1. 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: 2 years

  2. Time to prostate specific antigen (PSA) progression

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

    Measured: 2 years

  3. Radiographic Progression Free Survival(rPFS)

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

    Measured: 2 years

  4. OS

    Time from randomisation to death due to any cause

    Measured: 2 years

  5. DoR

    Time from radiologically confirmed reponse to radiologically confirmed progressive disease or death

    Measured: 2 years

  6. 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: 2 years

Timeline

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

  1. First posted21 Dec 2020
  2. Study start17 Dec 2020
  3. Primary completion12 Jun 2023
  4. Study completion12 Jun 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04676607
Sponsor's protocol ID
mCRPC-IIT-SHR7390
Status last verified
Jun 2023
First submitted
16 Dec 2020
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR7390 in people with Metastatic Castration-resistant Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 13 inclusion and 17 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: finished, as of the sponsor's last update on 13 Jun 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective response rate (ORR) (time frame: 2 years). 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 NCT04676607.

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 13 Jun 2023.

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