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

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ClinicalTrials.gov Identifier: NCT03450109
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer of Prostate Drug: LY01005 Drug: Zoladex Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: LY01005
One LY01005 3.6 mg gluteal IM injection.
Drug: LY01005
One gluteal IM injection

Active Comparator: Zoladex
One Zoladex 3.6 mg subcutaneous injection into the anterior abdominal wall
Drug: Zoladex
One Subcutaneous injection in the abdominal wall
Other Name: Goserelin




Primary Outcome Measures :
  1. The bio-availability of goserelin in subjects receiving goserelin compared to Zoladex using Pharmacokinetic lab results [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. The bio-availability of goserelin in subjects receiving LY01005 compared to Zoladex using Pharmacodynamic lab results [ Time Frame: 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 ]
    Maximum concentration (Cmax) Assessment Maximum concentration (Cmax) for the Pharmacokinetics (PK) of goserelin from LY01005 and ODV from Zoladex will be determined.


Other Outcome Measures:
  1. Safety profiles of LY01005 compared to goserelin comparator after a single injection [ Time Frame: Safety parameters are collected at screening, days 0,2,4,7, 10, 13, 16, 19, 22, 25, 29,36, and follow up phone call ]
    Collection of adverse events throughout the study as a measure of safety and tolerability.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  1. 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);
  2. 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;
  3. Any patient at risk of urinary tract obstruction or spinal cord compression due to potential testosterone surge;
  4. Patients with confirmed symptoms or signs related with to cerebral metastasis or radiographically confirmed brain metastases;
  5. Patients with a history or presence of any other malignancy except recovered from basal cell carcinoma with no recurrence within the last 3 years;
  6. Patients with a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema;
  7. Patients with uncontrolled diabetes mellitus;
  8. Patients with a history of hypersensitivity towards any components of the study drug;
  9. 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;
  10. Patients who are taking medications for seizures or oral steroids such as dexamethasone, methylprednisolone or prednisone;
  11. Patients who have taken 5α-reductase inhibitors (finasteride, dutasteride, and epristeride, etc.) within 3 months prior to Baseline Visit (Day 0);
  12. Patients with an intellectual incapacity or language barrier precluding adequate understanding or co operation;
  13. 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;
  14. Patients who are part of an ongoing trial;
  15. Patients with an ECG at Screening of with a QTc >450 ms or have a family history of prolonged QT syndrome;
  16. Patients with abnormal laboratory results which in the judgment of the investigator would affect the patient's health or the outcome of the trial;
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450109


Contacts
Contact: Jean Mastrangelo, MSHS 609 651-4352 jean.mastrangelo@luye.com
Contact: Samantha Allen-Johnson 215.855.9054 ext 7018 Samantha Allen-Johnson <sallen@clinlogix.com>

Locations
United States, Alabama
Pinnacle Research LLC Recruiting
Anniston, Alabama, United States, 36207
Contact: Ruby Fields    256-236-0055    rfields@pinnacletrials.com   
Principal Investigator: Terry Phillis, MD         
United States, Florida
South Florida Medical Research Recruiting
Aventura, Florida, United States, 33180
Contact: Sayonara Nunez    305-931-8080    snunez@southfloridamedicalresearch.com   
Contact: Phillippa McCartney    305-931-8080    Pmccartney@southfloridamedicalresearch.com   
Principal Investigator: Marc Gittelman, MD         
Clinical Research Center of Flordia Recruiting
Pompano Beach, Florida, United States, 33060
Contact: Jordan Herman    954-946-8873    jordan@floridacrc.com   
Principal Investigator: Craig Herman, MD         
Florida Urology Partners Recruiting
Tampa, Florida, United States, 33615
Contact: Linda Seibert    239-223-4488    linda@gulfcoastcta.com   
Principal Investigator: Osvaldo Padron, MD         
United States, Texas
Urology, San Antonio Recruiting
San Antonio, Texas, United States, 78909
Contact: Laura Ramirez    210-617-4544    Laura.Ramirez@urologysa.com   
Principal Investigator: Daniel Saltzstein, MD         
Sponsors and Collaborators
Luye Pharma Group Ltd.

Additional Information:
Responsible Party: Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier: NCT03450109     History of Changes
Other Study ID Numbers: LY01005/CT-USA-101
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents