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Cancer of ProstatePhase 1NCT03450109

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

A Phase 1 study testing LY01005 and Zoladex in people with Cancer of Prostate, run by Luye Pharma Group Ltd. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Cancer of Prostate
What is being tested?
LY01005 and Zoladex
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
5 sitesUnited States
Study dates
22 Dec 2017to 30 Oct 2018
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

  • 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.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Pinnacle Research LLC

    Anniston, Alabama, 36207

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Clinical Research Center of Flordia

    Pompano Beach, Florida, 33060

  • Urology, San Antonio

    San Antonio, Texas, 78909

  • Florida Urology Partners

    Tampa, Florida, 33615

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
LY01005, Zoladex
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

    One gluteal IM injection

  • ZoladexDrug

    Also called Goserelin

    One Subcutaneous injection in the abdominal wall

Study groups in NCT03450109
Study groupRoleWhat they receive
LY01005ExperimentalOne LY01005 3.6 mg gluteal IM injection.
Receives: Drug: LY01005
ZoladexActive comparatorOne Zoladex 3.6 mg subcutaneous injection into the anterior abdominal wall
Receives: Drug: Zoladex

What is being measured

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

  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.

    Measured: 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)

  1. 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.

    Measured: 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

Timeline

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

  1. First posted1 Mar 2018
  2. Study start22 Dec 2017
  3. Primary completion15 Oct 2018
  4. Study completion30 Oct 2018

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03450109
Sponsor's protocol ID
LY01005/CT-USA-101
Status last verified
Jan 2019
First submitted
23 Jan 2018
Last updated
7 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY01005 and Zoladex in people with Cancer of Prostate, run by Luye Pharma Group Ltd. at 5 sites in United States.

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 1 inclusion and 17 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 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

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). 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 NCT03450109.

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 7 Jan 2019.

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