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Castration-Resistant Prostate CancerPhase 1NCT05607693

A SHR3680 QT/QTc Study on Castration-Resistant Prostate Cancer Subjects

A Phase 1 study testing SHR3680 tablets in people with Castration-Resistant Prostate Cancer, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The purpose of this study is to determine whether daily treatment with SHR3680 affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC). Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Castration-Resistant Prostate Cancer
What is being tested?
SHR3680 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
26 Apr 2023to 5 Nov 2024
Phase
Phase 1
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 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male between 18 years to 75 years of age;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Expected survival of at least 6 months;
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without indication of neuroendocrine or small cell features; nonmetastatic castration-resistant prostate cancer (NM-CRPC) or metastatic castration-resistant prostate cancer (mCRPC) ;
  • Be surgically or medically castrated and if treated with a gonadotropin releasing hormone analog (ie, patient who has not undergone bilateral orchiectomy), then this therapy must have been initiated at least 4 weeks prior to Day 1 and must be continued throughout the study;
  • Castrated level of testosterone at screening (≦ 50 ng/dL or 1.73 nmol/L);
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  • Organ function level must meet the following requirements (blood transfusion or hematopoietic growth factor therapy was not received within 2 weeks before blood test):
  • ANC≧1.5×109/L；
  • PLT≧80×109/L；
  • Hb≧90 g/L；
  • TBIL≦1.5×ULN；
  • ALT and AST≦2.5×ULN；
  • BUN and Cr≦1.5×ULN；
  • GFR≧60ml/min/1.73m2；
  • 12-lead ECG: heart rate ≥ 50 beats/min, PR interval within 110-220 ms (including both ends), QTc interval corrected according to Fridericia 's criteria (QTcF) < 470 msec. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
  • Able to complete the study as required by the protocol;
  • Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions.

Who cannot join

  • Washout period of any previous anti-tumor therapy (including radiotherapy, chemotherapy, surgery, molecular targeted therapy, immunotherapy, androgen receptor antagonists, CYP-17 inhibitors, 5α-reductase inhibitors, estrogen, progesterone drugs, etc.) to the of the first dose of this study drug is < 4 weeks;
  • Plan to receive any other anti-tumor therapy during the treatment phase in this trial;
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 4 weeks;
  • Known brain metastases;
  • history of epilepsy, or past medical history of disease that can induce seizures (including transient ischemic attack history, cerebral stroke (except cerebral ischemic lesions only found in imaging test), brain trauma with disturbance of consciousness requiring hospitalization) within 12 months before the first dose of the study drug;
  • past medical history of the following diseases within 6 months before screening: myocardial infarction, severe/unstable angina, NYHA class II-IV cardiac insufficiency, ≥ Grade 2 sustained arrhythmia (graded based on NCI CTCAE 5.0), heart failure, grade II-III atrioventricular block, complete left bundle branch block, atrial fibrillation of any grade, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis;
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  • Inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of multiple other factors affecting drug administration and absorption;
  • Patients with active HBV or HCV infection (HBV copy number ≥ 104 copies/mL, HCV copy number ≥ 103 copies/mL);
  • Patients with immunodeficiency disease history (including HIV test positive, other acquired or congenital immunodeficiency diseases) or organ transplantation history;
  • Patients who are unwilling to take protocol-specified contraceptive measures throughout the study treatment period and within 3 months after the last dose;
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound or known allergy to SHR3680 or the excipients;
  • Excessive smoking (≥ 5 cigarettes/day) within 6 months before screening or smoking within 48 h before the first dose, or positive at nicotine screening test, and can't abstain from smoking during the study; History of drug abuse, positive at drug abuse screening, or history of any drug use in the past 6 months;
  • History of alcoholism or regular alcohol consumption within 6 months before screening, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol or 45 mL of spirits with 40% alcohol or 150 mL of wine with 12% alcohol) or drinking within 48 h before the first dose, or positive at alcohol breath test on the day of admission, or unable to abstain during the study;
  • Subjects who took any vitamins, health products or herbal medicine within 14 days before dosing;
  • Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or alcohol within 48 hours before dosing; strenuous exercise; or other factors which affect drug absorption, distribution, metabolism, excretion, etc;
  • Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency or on thrombolytic therapy;
  • Patients with implantable pacemaker and automatic implantable cardioverter defibrillator;
  • Personal or family history of long QT syndrome;
  • Use of Medications that prolong QT/QTc interval or with risk of torsades de pointes (TdP) within 7 days prior administration of study drug;
  • Significant history or clinical manifestation of concomitant diseases or other situations that put serious hazards to the patient' s safety, or affect the patient 's completion of the study, as determined by the Investigator.

Trial locations and contacts

1 site in 1 country.

YIKE WANG, Pharm.D contact

+86-134-0862-8814

yike.wang@hengrui.com

Shaorong Li, Ph.D contact

+86-180-0162-4511

shaorong.li@hengrui.com

China1 site, 1 recruiting

  • Cancer Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300000

    Xin Yao, Doctor, 022-23340123-3100, yaoxin@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: A Multi-Center, Open- Label, Single-Arm Phase 1 QT/QTc Study of SHR3680 in Subjects With Castration-Resistant Prostate Cancer

The purpose of this study is to determine whether daily treatment with SHR3680 affects the ventricular repolarization in participants with Castration-Resistant Prostate Cancer (CRPC).

Being tested
SHR3680 tablets

What participants receive

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

  • SHR3680 tabletsDrug

    Subjects start taking SHR3680 tablets 240 mg/dose/day orally on an empty stomach on D1, and the timing of administration daily should be consistent when possible.

Study groups in NCT05607693
Study groupRoleWhat they receive
SHR3680ExperimentalNot described
Receives: Drug: SHR3680 tablets

What is being measured

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

  1. Delta QTc Fridericia (QTcF)

    Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.

    Measured: Day -1 and Day 1 and Day 17

  2. Concentration-delta QTcF relationship

    Relationship between SHR3680 plasma concentration and delta QTcF based on linear-mixed effect model.

    Measured: Day -1 and Day 1 and Day 17

Secondary outcomes (12)

  1. Electrocardiographic parameters Delta PR

    A change from time-matched baseline measurements in PR interval will be determined on Day -1, Day 1 and Day 17.

    Measured: Day -1 and Day 1 and Day 17

  2. Electrocardiographic parameters Delta RR

    A change from time-matched baseline measurements in RR interval will be determined on Day -1, Day 1 and Day 17.

    Measured: Day -1 and Day 1 and Day 17

  3. Electrocardiographic parameters Delta QRS

    A change from time-matched baseline measurements in QRS interval will be determined on Day -1, Day 1 and Day 17.

    Measured: Day -1 and Day 1 and Day 17

  4. Electrocardiographic parameters Delta QTc Bazett (QTcB)

    Mean change from baseline in QTcB as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.

    Measured: Day -1 and Day 1 and Day 17

  5. Electrocardiographic parameters T-wave morphology

    Number and percentage of participants with changes from baseline

    Measured: Day -1 and Day 1 and Day 17

  6. Electrocardiographic parameters U-wave morphology

    Number and percentage of participants with changes from baseline

    Measured: Day -1 and Day 1 and Day 17

  7. Incidence and severity of AE/SAE/AESI (rated based on CTCAE v5.0)

    Participants will be monitored for safety during the Screening and Treatment Phases, and up to 30 days after the last dose of study drug. From the end of treatment phase onward collection of AE will be limited to Grade 3 or higher, all SAE and AESI from the remainder of the study.

    Measured: Day-1, Day 1 to Day 18

  8. Pharmacokinetic parameter area under the plasma drug concentration-time curve (AUC) from time 0 to 24 hours

    Measured: Day 1-2 and Day 17-18

  9. Pharmacokinetic parameter maximum concentration observed (Cmax)

    Measured: Day 1-2 and Day 17-18

  10. Pharmacokinetic parameter time to reach Cmax (tmax)

    Measured: Day 1-2 and Day 17-18

  11. Pharmacokinetic parameter minimum observed plasma concentration at steady-state (Cmin,ss)

    Measured: Cmin,ss will only be collected on Day 17

  12. Pharmacokinetic parameter accumulation ratio（Rac）

    Measured: Day 1-2 and Day 17-18

Timeline

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

  1. First posted7 Nov 2022
  2. Study start26 Apr 2023
  3. Primary completion5 Nov 2024 (estimated)
  4. Study completion5 Nov 2024 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multiple dose of SHR3680 will be administered
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607693
Sponsor's protocol ID
SHR3680-I-QTc
Status last verified
May 2023
First submitted
12 Oct 2022
Last updated
15 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR3680 tablets in people with 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 17 inclusion and 20 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 15 May 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 YIKE WANG, Pharm.D (+86-134-0862-8814, yike.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delta QTc Fridericia (QTcF) (time frame: Day -1 and Day 1 and Day 17). 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 NCT05607693.

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 15 May 2023.

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