Prostate CancerPhase 1NCT03029533
Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following SC Administration of DWJ108J in Patients With Prostate Cancer
A Phase 1 study testing Leuprolide Acetate in people with Prostate Cancer, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with prostate cancer Read more about this study
- Who is it for?
- Ages 19 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Leuprolide Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Nov 2017
- 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 19 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males ≥19 and ≤80 years of age at Screening.
- Subject with histologically proven adenocarcinoma of the prostate requiring androgen deprivation therapy
- An ECOG performance status grade of 0 to 2,
- 19kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening.
Who cannot join
- Confirmed Hormone refractory prostate cancer(HRPC)
- Has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy.
- Diagnosed pituitary adenoma
- Has a history of depression
- Has a risk of spinal cor d compression due to metastatic spinal cord injury.
- Has a severe urethratresia.
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- Confirmed uncontrolled Congestive heart failure (CHF) within 6 months of Screening.
- Has a history of MI or any procedure with regard to coronary artery disease within 6 months of Screening. (e.g., balloon angioplasty, coronary artery bypass graft)
- Has any severe concomitant disease that would interfere with the conduct of the study except for prostate cancer
- Has allergy history of leuprolide acetate, similar GnRH drugs or other medications (e.g., Aspirin, antibiotics) and/or has any allergic disease requiring treatment.
- Has received an investigational drug within 9 0days of Screening.
- Drug releasing is expected after administration of study drug, if subject received GnRH agonist for treatment of prostate cancer.
- Has other chemotherapy planned within 14weeks from administration of study drug, except for androgen deprivation therapy.
- Has no willing of using method of contraception throughout the study period.
- Systolic Blood Pressure < 90mmHg and/or ≥160mmHg or Diastolic Blood Pressure < 60mmHg and/or ≥100mmHg at Screening
- QTcF >450msec at Screening ECG.
- HbA1c level is high the upper limit of normal of reference range.
- Serum AST, ALT or Creatinine > 1.5times the upper limit of normal at Screening.
- Positive results of tests for hepatitis B, hepatitis C, HIV or syphilis.
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject.
About this study
Official title: An Open Label, Randomized, Single Dose, Parallel-group, Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following Subcutaneous Administration of DWJ108J in Patients With Prostate Cancer
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with prostate cancer
- Conditions
- Prostate Cancer
- Being tested
- Leuprolide Acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide AcetateDrug
Also called DWJ108J
DWJ108J, SC injection, once(Day1)
Leuprolide AcetateDrug
Also called Leuplin DPS Inj
Leuplin DPS Inj, SC injection, once(Day1)
| Study group | Role | What they receive |
|---|---|---|
| DWJ108J (leuprolide acetate) | Experimental | DWJ108J (leuprolide acetate) Receives: Drug: Leuprolide Acetate |
| Leuplin DPS Inj | Active comparator | Leuplin DPS Inj Receives: Drug: Leuprolide Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Measured: Day 99
Area under the plasma concentration versus time curve (AUC)
AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf
Measured: Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionNov 2017 (estimated)
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 Daewoong Pharmaceutical Co. 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029533
- Sponsor's protocol ID
- DW_LP3M002
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, Parallel-group, Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following Subcutaneous Administration of DWJ108J in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT03029533
- Acronym / sponsor ID
- DW_LP3M002
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Feb 2017
- Primary completion
- Nov 2017 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with prostate cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ108J (leuprolide acetate) | Experimental | Drug: Leuprolide AcetateDWJ108J (leuprolide acetate) |
| Leuplin DPS Inj | Active comparator | Drug: Leuprolide AcetateLeuplin DPS Inj |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males ≥19 and ≤80 years of age at Screening.
- Subject with histologically proven adenocarcinoma of the prostate requiring androgen deprivation therapy
- An ECOG performance status grade of 0 to 2,
- 19kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening.
Key exclusion criteria (20 listed)
- Confirmed Hormone refractory prostate cancer(HRPC)
- Has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy.
- Diagnosed pituitary adenoma
- Has a history of depression
- Has a risk of spinal cor d compression due to metastatic spinal cord injury.
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 |
|---|---|---|
| Leuprolide AcetateAlso: DWJ108JDWJ108J, SC injection, once(Day1) | Drug | DWJ108J (leuprolide acetate) |
| Leuprolide AcetateAlso: Leuplin DPS InjLeuplin DPS Inj, SC injection, once(Day1) | Drug | Leuplin DPS Inj |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: Day 99
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 99
AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Leuprolide Acetate in people with Prostate Cancer, run by Daewoong Pharmaceutical Co. LTD..
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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Peak Plasma Concentration (Cmax) (time frame: Day 99). The study lists 2 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 24 Jan 2017.