Prostate CancerPhase 1NCT05140512
Pharmacokinetics, Pharmacodynamics and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®
A Phase 1 study testing LY01005 and ZOLADEX® 3.6 mg in people with Prostate Cancer, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a randomized, open-label and parallel phase I study to compare pharmacokinetics (PK), pharmacodynamics (PD) and safety of goserelin acetate sustained-release microspheres for injection (LY01005) and ZOLADEX® following multiple administration in patients with prostate cancer. 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?
- LY01005 and ZOLADEX® 3.6 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2021to 26 Nov 2021
- 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 (such as patients with biochemical recurrence after adjuvant endocrine therapy and radical 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, total bilirubin (TBIL) ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases), and 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 3 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.
- Has previously received goserelin.
- Is receiving coumarin anticoagulants at the screening visit.
- Has 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 human immunodeficiency virus (HIV) 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).
- Has participated in any clinical trials of investigational drugs or medical devices, and discontinued within 1 month or 5 half-lives of the corresponding drug before the screening visit, whichever is longer.
- 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.
About this study
Official title: A Randomized, Open-label and Parallel Phase I Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® Following Multiple Administration in Patients With Prostate Cancer
This is a randomized, open-label and parallel phase I study to compare pharmacokinetics (PK), pharmacodynamics (PD) and safety of goserelin acetate sustained-release microspheres for injection (LY01005) and ZOLADEX® following multiple administration in patients with prostate cancer.
Read the detailed description
This is a randomized, open-label, active-controlled phase I trial. A total of 23 patients with locally advanced or metastatic prostate cancer who were suitable for endocrine therapy were enrolled into the screening period from D-21 to D-10 (±3d) before administration. Eligible subjects were treated with bicalutamide tablets (Casodex®, 50 mg/day) from D-10 (± 3d) to the end of the trial and randomized in a 1:1 ratio to receive LY01005 3.6 mg or ZOLADEX ® 3.6 mg after completion of pretreatment. All subjects were administered once every 28 days for three doses. Blood samples were collected at the specified time points in the trial protocol to detect PK parameters of goserelin, and PD parameters (serum testosterone, LH and FSH). Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) was conducted as required in the protocol. This study aimed to compare PK/PD and safety of LY01005 and ZOLADEX® in patients with locally advanced or metastatic prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- LY01005, ZOLADEX® 3.6 mg
- Keywords
- Prostate Cancer, LY01005, PK/PD, Safety
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY01005Drug
Also called Goserelin Acetate Sustained-Release Microspheres for Injection
LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.
ZOLADEX® 3.6 mgDrug
Also called Goserelin Acetate Implant 3.6 mg
ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.
| Study group | Role | What they receive |
|---|---|---|
| LY01005 3.6 mg | Experimental | Intramuscular injections of LY01005 3.6 mg every 28 days for a maximum of 3 consecutive doses. Receives: Drug: LY01005 |
| ZOLADEX® 3.6 mg | Active comparator | Subcutaneous injections of ZOLADEX® 3.6 mg every 28 days for a maximum of 3 consecutive doses. Receives: Drug: ZOLADEX® 3.6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Plasma concentration of goserelin over time.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Cmax.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Ctrough.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: AUC0-t.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: AUC0-∞.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Tmax.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: T1/2.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Vz/F.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Cl/F.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: MRT0-∞.
Measured: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: accumulation of goserelin.
Measured: from baseline to Day 85
Secondary outcomes (16)
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: AUEC of serum testosterone.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: Emax of serum testosterone.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: TEmax of serum testosterone.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: AUEC of serum LH.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: Emax of serum LH.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: TEmax of serum LH.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: AUEC of serum FSH.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: Emax of serum FSH.
Measured: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: TEmax of serum FSH.
Measured: from baseline to Day 85
The percentage of subjects with serum testosterone ≤50 ng/dL (1.735 nmol/L) on Day 29 after the first dose.
Measured: Day 29 after the first dose
The cumulative percentage of subjects with the maintenance of serum testosterone ≤50 ng/dL (1.735 nmol/L) from Day 29 to Day 85.
Measured: from Day 29 to Day 85
Significant Castration Rate.
The percentage of subjects with serum testosterone ≤20 ng/dL (0.7 nmol/L) on Day 29 after the first dose, and the cumulative percentage of subjects with the maintenance of serum testosterone ≤20 ng/dL (0.7 nmol/L) from Day 29 to Day 85.
Measured: from Day 29 to Day 85
The percentage of subjects with serum testosterone > 50 ng/dL on 1 hour, 4 hours, Day 3 and Day 7 after the second dose and the third dose.
Measured: 1 hour, 4 hours, Day 3 and Day 7 after the second dose and the third dose
Percentage changes compared to baseline in serum FSH level after each administration.
Measured: Day 29, Day 57 and Day 85
Percentage changes compared to baseline in serum LH level after each administration.
Measured: Day 29, Day 57 and Day 85
Adverse events throughout the study.
Measured: up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start4 Feb 2021
- Primary completion15 Sep 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140512
- Sponsor's protocol ID
- LY01005/CT-CHN-104
- Status last verified
- May 2023
- First submitted
- 3 Nov 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label and Parallel Phase I Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® Following Multiple Administration in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT05140512
- Acronym / sponsor ID
- LY01005/CT-CHN-104
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, LY01005, PK/PD, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label and parallel phase I study to compare pharmacokinetics (PK), pharmacodynamics (PD) and safety of goserelin acetate sustained-release microspheres for injection (LY01005) and ZOLADEX® following multiple administration in patients with prostate cancer.
Detailed description
This is a randomized, open-label, active-controlled phase I trial. A total of 23 patients with locally advanced or metastatic prostate cancer who were suitable for endocrine therapy were enrolled into the screening period from D-21 to D-10 (±3d) before administration. Eligible subjects were treated with bicalutamide tablets (Casodex®, 50 mg/day) from D-10 (± 3d) to the end of the trial and randomized in a 1:1 ratio to receive LY01005 3.6 mg or ZOLADEX ® 3.6 mg after completion of pretreatment. All subjects were administered once every 28 days for three doses. Blood samples were collected at the specified time points in the trial protocol to detect PK parameters of goserelin, and PD parameters (serum testosterone, LH and FSH). Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) was conducted as required in the protocol. This study aimed to compare PK/PD and safety of LY01005 and ZOLADEX® in patients with locally advanced or metastatic prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY01005 3.6 mg | Experimental | Drug: LY01005Intramuscular injections of LY01005 3.6 mg every 28 days for a maximum of 3 consecutive doses. |
| ZOLADEX® 3.6 mg | Active comparator | Drug: ZOLADEX® 3.6 mgSubcutaneous injections of ZOLADEX® 3.6 mg every 28 days for a maximum of 3 consecutive doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older.
- Patients with locally advanced or metastatic prostate cancer suitable for endocrine therapy, including those who are suitable for endocrine therapy (such as patients with biochemical recurrence after adjuvant endocrine therapy and radical 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY01005Also: Goserelin Acetate Sustained-Release Microspheres for InjectionLY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period. | Drug | LY01005 3.6 mg |
| ZOLADEX® 3.6 mgAlso: Goserelin Acetate Implant 3.6 mgZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period. | Drug | ZOLADEX® 3.6 mg |
Primary outcome
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Plasma concentration of goserelin over time.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Cmax.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Ctrough.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: AUC0-t.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: AUC0-∞.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Tmax.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: T1/2.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Vz/F.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Cl/F.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: MRT0-∞.
Time frame: from baseline to Day 85
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: accumulation of goserelin.
Time frame: from baseline to Day 85
16 secondary outcomes
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: AUEC of serum testosterone.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: Emax of serum testosterone.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: TEmax of serum testosterone.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: AUEC of serum LH.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: Emax of serum LH.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: TEmax of serum LH.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: AUEC of serum FSH.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: Emax of serum FSH.
Time frame: from baseline to Day 85
Pharmacodynamic Profile of LY01005 versus ZoLADEX®: TEmax of serum FSH.
Time frame: from baseline to Day 85
The percentage of subjects with serum testosterone ≤50 ng/dL (1.735 nmol/L) on Day 29 after the first dose.
Time frame: Day 29 after the first dose
The cumulative percentage of subjects with the maintenance of serum testosterone ≤50 ng/dL (1.735 nmol/L) from Day 29 to Day 85.
Time frame: from Day 29 to Day 85
Significant Castration Rate.
Time frame: from Day 29 to Day 85
The percentage of subjects with serum testosterone > 50 ng/dL on 1 hour, 4 hours, Day 3 and Day 7 after the second dose and the third dose.
Time frame: 1 hour, 4 hours, Day 3 and Day 7 after the second dose and the third dose
Percentage changes compared to baseline in serum FSH level after each administration.
Time frame: Day 29, Day 57 and Day 85
Percentage changes compared to baseline in serum LH level after each administration.
Time frame: Day 29, Day 57 and Day 85
Adverse events throughout the study.
Time frame: up to Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY01005 and ZOLADEX® 3.6 mg 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 8 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: finished, as of the sponsor's last update on 16 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?
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?
Pharmacokinetic Profile of LY01005 versus ZoLADEX®: Plasma concentration of goserelin over time. (time frame: from baseline to Day 85). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2023.