A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer

Study Overview
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Brief Summary
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A phase I, randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.

Detailed Description
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This will be a randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.

Official Title
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A Randomized and Open-label Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of LY01005 Versus Goserelin Comparator (ZOLADEX®) Following a Single Administration in Patients With Prostate Cancer

Conditions
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Cancer of Prostate

Intervention / Treatment
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* Drug: LY01005
* Drug: Zoladex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Patient with an informed consent signed by the patient himself or legally acceptable representative before any trial-related activities; 2.2. Male patients diagnosed by confirmation of prostate cancer of any stages for whom endocrine treatment is indicated; patients with laboratory evidence of biochemical recurrence (BCR) are allowed. BCR is defined as the presence of prostate-specific antigen (PSA) greater than 0.2 ng/mL measured 6 to 13 weeks after radical prostatectomy followed by a confirmatory test showing persistent PSA greater than 0.2 ng/mL; or PSA nadir + 2 ng/mL (treated with radiation therapy); or PSA doubling time < 6 months without radiographic evidence of recurrence 3.Patients with a Screening testosterone level >1.5 ng/ml; 4.Patients with a life expectancy of at least 12 months; 5.Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2; 6.Patient understands and is willing to comply with the protocol and related procedures; 7.If having female sexual partners of childbearing potential, agree to avoid the occurrence of pregnancy during study participation and for 130 days after completing the study by using a highly effective method of contraception such as barrier method and female contraceptives, including spermicides, etc. Exclusion Criteria: Patients with a history of orchiectomy, adrenectomy or pituitary resection or receiving radiotherapy for prostate cancer (patients with prostatectomy are eligible for the study as are patients who received radiotherapy as long as radiotherapy was not received within 6 months prior to Screening); Patients who have previously received hormonal therapy for prostate cancer, including surgical deprivation or sex hormone-regulating agents such as GnRH agonists/inhibitors as well as estrogen therapy. However, patients previously treated with neo-adjuvant therapy or adjuvant hormonal therapy for less than 6 months with an interval of at least 6 months since discontinuation of such therapy at the time of the Screening Visit can be enrolled; Any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge; Patients with confirmed symptoms or signs related with to cerebral metastasis or radiographically confirmed brain metastases; Patients with a history or presence of any other malignancy except recovered from basal cell carcinoma with no recurrence within the last 3 years; Patients with a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema; Patients with uncontrolled diabetes mellitus; Patients with a history of hypersensitivity towards any components of the study drug; Patients who test positive for drugs of abuse or alcohol, have smoked or otherwise used nicotine-containing products within 6 months prior to the Screening Visit, are smokers, drug abusers or have taken alcohol within 24 hours prior to dosing; Patients who are taking medications for seizures or oral steroids such as dexamethasone, methylprednisolone or prednisone; Patients who have taken 5α-reductase inhibitors (finasteride, dutasteride, and epristeride, etc.) within 3 months prior to Baseline Visit (Day 0); Patients with an intellectual incapacity or language barrier precluding adequate understanding or co operation; Patients who have received an investigational drug within the last 30 days before the Screening Visit or longer if considered to possibly influence the outcome of this trial; Patients who are part of an ongoing trial; Patients with an ECG at Screening of with a QTc >450 ms or have a family history of prolonged QT syndrome; Patients with abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial; Patients with a clinically significant medical condition (other than prostate cancer) including but not limited to: renal, hematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease, alcohol or drug abuse or any other condition that may affect the patient's health or the outcome of the trial as judged by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY01005<br>One LY01005 3.6 mg gluteal IM injection. | Drug: LY01005<br>* One gluteal IM injection<br>|
| Active Comparator: Zoladex<br>One Zoladex 3.6 mg subcutaneous injection into the anterior abdominal wall | Drug: Zoladex<br>* One Subcutaneous injection in the abdominal wall<br>* Other names: Goserelin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bio-availability of goserelin in subjects receiving goserelin compared to Zoladex using Pharmacokinetic lab results | Area under the concentration-time curve (AUC) Assessment Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of gosereling from LY01005 and goserelin from Zoladex will be determined. | The pharmacokinetic (PK) labs will be drawn at -30 minutes of dosing, .25, .5, 1, and 6 hours of dosing and days 7, 10, 13, 16, 19, 22, 25, 29 and 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bio-availability of goserelin in subjects receiving LY01005 compared to Zoladex using Pharmacodynamic lab results | Maximum concentration (Cmax) Assessment Maximum concentration (Cmax) for the Pharmacokinetics (PK) of goserelin from LY01005 and ODV from Zoladex will be determined. | The pharmacodynamic (PD) labs will be drawn at screening -30 minutes of dosing, .25, .5, 1, and 6 hours of dosing and days 2,4,7, 10, 13, 16, 19, 22, 25, 29 and 36 |