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Prostate CancerPhase 1NCT05856630

Pharmacokinetics Pharmacodynamics and Safety of LY01022 in Patients With Prostate Cancer Compared With Zoladex® 10.8mg

A Phase 1 study testing Goserelin Acetate Sustained-Release Microspheres for Injection and Zoladex 10.8 MG Drug Implant in people with Prostate Cancer, run by Luye Pharma Group 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a randomized, open-label, Parallel, active-controlled phase I study. A total of 20-24 patients with locally advanced or metastatic prostate cancer will be randomized in a 1:1 ratio to receive a single injection of LY01022 10.8mg or Zoladex® 10.8mg. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Goserelin Acetate Sustained-Release Microspheres for Injection and Zoladex 10.8 MG Drug Implant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
May 2023to Dec 2023
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older.
  • Patients with locally advanced or metastatic prostate cancer suitable for endocrine therapy, including those who are suitable for endocrine therapy following radical therapy.
  • Serum testosterone level ≥ 150 ng/dL (1.50 ng/mL or 5.2 nmol/L) at the screening visit.
  • Life expectancy of at least 9 months.
  • ECOG score of ≤ 2.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count ≥ 90 x 10^9/L, white blood cell count ≥ 3 x 10^9/L, hemoglobin ≥ 90 g/L.
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  • Total bilirubin (TBIL) ≤ 1.5×ULN, ALT and AST ≤ 3×ULN (or ≤ 5.0×ULN for patients with liver metastases).
  • Creatinine clearance ≥50 mL/min at the screening visit.
  • Subjects of childbearing potential must agree to use a reliable method of contraception with their female sexual partners during the study period and at least 6 months after the last administration.
  • Patients who voluntarily sign an IRB-approved informed consent form before any trial-related activities, are willing to abide by the restrictions of the study, and complete the prescribed examinations.

Who cannot join

  • Patients with prostate cancer who receive previous or ongoing endocrine therapy (surgical castration or other endocrine therapy including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, etc.), except for patients with prostate cancer undergoing prostatectomy, radiotherapy or cryotherapy who have received neoadjuvant/adjuvant endocrine therapy for no more than 6 months and discontinued the above therapy more than 6 months before screening.
  • Patients with confirmed or suspected hormone-resistant prostate cancer.
  • Patients who have received prostatic surgery within 4 weeks prior to the first dose, or plan to receive major surgical treatment during the trial.
  • Patients who have previously received hypophysectomy or adrenalectomy, or who have pituitary lesions or adrenal dysfunction.
  • History of severe asthma, anaphylaxis, or severe urticaria and/or angioedema.
  • Other cancer diseases diagnosed within 5 years before the screening visit, except for surgically removed basal or squamous cell carcinoma of the skin.
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  • History of the following medical histories within 6 months prior to the screening visit: stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina, coronary revascularization, New York Heart Association (NYHA) class ≥ II cardiac insufficiency, severe unstable arrhythmia.
  • Hypertensive patients with poor blood pressure control (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg at the screening visit).
  • Patients with type 1 diabetes or type 2 diabetes with poor glycemic control (glycosylated hemoglobin > 8% at the screening visit).
  • Patients who have received treatment with 5-α reductase inhibitors (finasteride, dutasteride, enalidomide, epristeride, etc.) within 4 weeks before the first dose.
  • Patients who are receiving coumarin anticoagulants at the screening visit.
  • Have congenital long QT syndrome or QT/QTc interval prolongation (QTc ≥ 450 ms) at the screening visit; Or has received drugs that may prolong QT/QTc interval at the screening visit.
  • Known to be allergic to the active ingredients or any excipients of GnRH agonists or bicalutamide.
  • Patients who are seropositive for hepatitis B surface antigen (HBsAg), and must meet the following 2 conditions at the same time: 1. HBV DNA level: HBeAg-positive patients, HBV DNA ≥ 20,000 IU/ml [equivalent to 10^5 copies/mL]; HBeAg-negative patients, HBV DNA ≥ 2,000 IU/ml [equivalent to 10^4 copies/mL]; 2. ALT ≥ 2 x ULN);
  • Patients who are seropositive for HIV antibody or HCV antibody.
  • Alcoholics or drug abusers. Alcoholics are defined as drinking more than 14 units of alcohol per week within 3 months prior to the screening visit (1 unit = 350 mL beer, or 45 mL liquor, or 150 mL wine).
  • Have participated in any clinical trials of investigational drugs or medical devices, and discontinued within 1 month before the screening visit.
  • Other conditions considered unsuitable for enrollment by the investigator (such as spinal cord compression due to prostate cancer metastatic lesions of pyramid, pulmonary interstitial disease or other serious diseases).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou

Other trials in China

About this study

Official title: A Randomized, Open-label, Parallel, Active-controlled Phase 1 Study to Compare Pharmacokinetics Pharmacodynamics and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01022) With Zoladex® 10.8mg Following Single Administration in Patients With Prostate Cancer

This is a randomized, open-label, Parallel, active-controlled phase I study. A total of 20-24 patients with locally advanced or metastatic prostate cancer will be randomized in a 1:1 ratio to receive a single injection of LY01022 10.8mg or Zoladex® 10.8mg. Blood samples will be collected to evaluate PK and PD profiles, and safety evaluation will be conducted as required in the protocol.

Conditions
Prostate Cancer
Being tested
Goserelin Acetate Sustained-Release Microspheres for Injection, Zoladex 10.8 MG Drug Implant
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Goserelin Acetate Sustained-Release Microspheres for InjectionDrug

    Also called LY01022

    10.8mg, Single dose, subcutaneously（SC）

  • Zoladex 10.8 MG Drug ImplantDrug

    10.8mg, Single dose, subcutaneously（SC）

Study groups in NCT05856630
Study groupRoleWhat they receive
LY01022ExperimentalNot described
Receives: Drug: Goserelin Acetate Sustained-Release Microspheres for Injection
Zoladex®Active comparatorNot described
Receives: Drug: Zoladex 10.8 MG Drug Implant

What is being measured

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

  1. Changes in plasma goserelin concentration after administration of LY01022 or Zoladex®

    Measured: from baseline to Day 99

Secondary outcomes (4)

  1. Changes in serum testosterone concentration after administration of LY01022 or Zoladex®

    Measured: from baseline to Day 99

  2. Changes in serum luteinizing hormone (LH) concentration after administration of LY01022 or Zoladex®

    Measured: from baseline to Day 99

  3. Changes in serum follicle stimulating hormone (FSH) concentration after administration of LY01022 or Zoladex®

    Measured: from baseline to Day 99

  4. Adverse events throughout the study

    Measured: from baseline to Day 99

Timeline

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

  1. First posted12 May 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856630
Sponsor's protocol ID
LY01022/CT-CHN-101
Status last verified
May 2023
First submitted
22 Apr 2023
Last updated
12 May 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 1 study testing Goserelin Acetate Sustained-Release Microspheres for Injection and Zoladex 10.8 MG Drug Implant in people with Prostate Cancer, run by Luye Pharma Group 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 10 inclusion and 18 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 12 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?

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?

Changes in plasma goserelin concentration after administration of LY01022 or Zoladex® (time frame: from baseline to Day 99). 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 NCT05856630.

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 12 May 2023.

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