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Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following SC Administration of DWJ108J in Patients With Prostate Cancer
Plain-language guide to NCT03029533: phase 1 randomized trial of Leuprolide, 44 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03029533
- Phase
- phase 1
- Status
- status unknown
- Start
- 2017-02
- Completion (planned or actual)
- 2017-11
- Participants
- 44 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Leuprolide.
It had two arms (groups): DWJ108J (leuprolide acetate) (experimental) and Leuplin DPS Inj (active comparator).
DWJ108J (leuprolide acetate).
Leuplin DPS Inj.
The registry classes the interventions as drug.
Who Took Part
44 planned participants were the target.
It was open to men only aged from 19 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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.
The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: confirmed hormone refractory prostate cancer(hrpc); has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy; diagnosed pituitary adenoma.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.
The Leuprolide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.
It started in 2017-02 with completion listed for 2017-11.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Peak Plasma Concentration (Cmax) (time frame: Day 99). Area under the plasma concentration versus time curve (AUC) (time frame: Day 99).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Leuprolide in 44 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.