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

NCT03450109 | Completed Phase 1 FDA Drug

• 1 other identifier: LY01005/CT-USA-101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer of Prostate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The bio-availability of goserelin in subjects receiving LY01005 compared to Zoladex using Pharmacodynamic lab results

  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

Other Outcomes (1)

• Safety profiles of LY01005 compared to goserelin comparator after a single injection

  Safety parameters are collected at screening, days 0,2,4,7, 10, 13, 16, 19, 22, 25, 29,36, and follow up phone call

Study Arms (2)

LY01005

EXPERIMENTAL

One LY01005 3.6 mg gluteal IM injection.

Drug: LY01005

Zoladex

ACTIVE COMPARATOR

One Zoladex 3.6 mg subcutaneous injection into the anterior abdominal wall

Drug: Zoladex

Interventions

LY01005 DRUG

One gluteal IM injection

LY01005

Zoladex DRUG

One Subcutaneous injection in the abdominal wall

Also known as: Goserelin

Zoladex

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (5)

Pinnacle Research LLC

Anniston, Alabama, 36207, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Clinical Research Center of Flordia

Pompano Beach, Florida, 33060, United States

Location

Florida Urology Partners

Tampa, Florida, 33615, United States

Location

Urology, San Antonio

San Antonio, Texas, 78909, United States

Location

Related Links

• Zoladex Label

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: March 1, 2018
• Study Start: December 22, 2017
• Primary Completion: October 15, 2018
• Study Completion: October 30, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)