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NCT03150056 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer
A Phase 1 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT03150056: Clinical Trial Phase 1 study, sponsored by GlaxoSmithKline.
NCT03150056 is a Phase 1 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03150056, a Phase 1 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
This study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic (m)CRPC. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B).
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according t
Interventions
- DRUG Prednisone
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG GSK525762
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2017-07-18 |
| Est. Completion | 2021-06-22 |
| Phase | Phase 1 |
Why NCT03150056 stopped before completion
NCT03150056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT03150056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03150056 about?
NCT03150056 is a clinical study titled "Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy in Participants With Castrate-resistant Prostate Cancer". This study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic (m)CRPC. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pha...
What is the current status of trial NCT03150056?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2017-07-18. Estimated completion is 2021-06-22.
What interventions are being tested in trial NCT03150056?
The interventions under investigation include: Prednisone (DRUG), Enzalutamide (DRUG), Abiraterone (DRUG), GSK525762 (DRUG).
Who is sponsoring clinical trial NCT03150056?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03150056's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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