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NCT04060394 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC
A Phase 1 study, sponsored by Laekna Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT04060394: Completed Phase 1 study, sponsored by Laekna Limited.
NCT04060394 is a Phase 1 study that has completed, run by Laekna Limited. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04060394, a Phase 1 study, has completed, sponsored by Laekna Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
The combination treatment of protein kinase B (AKT) inhibitor, afuresertib, with androgen synthesis enzyme inhibitor, LAE001, may provide an effective treatment for metastatic castration resistant prostate cancer (m-CRPC) patients who have progressed/drug resistant following prior standard care treatments of any anti-androgen. This study intends to identify the most appropriate combined doses of LAE001/prednisone and afuresertib in m-CRPC patients who have progressive disease or are intolerant of 2 prior standard treatments of any anti-androgen or anti-androgen treatment plus chemotherapy.
Primary Outcome
Based on investigator reviewed radiographic tumor assessment.
Interventions
- DRUG Phase I and Phase II: LAE001/prednisone + afuresertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2019-09-13 |
| Est. Completion | 2024-03-30 |
| Phase | Phase 1 |
What the finished NCT04060394 record still lists
NCT04060394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which Phase I and Phase II: LAE001/prednisone + afuresertib is the first listed.
NCT04060394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04060394 about?
NCT04060394 is a clinical study titled "Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC". The combination treatment of protein kinase B (AKT) inhibitor, afuresertib, with androgen synthesis enzyme inhibitor, LAE001, may provide an effective treatment for metastatic castration resistant prostate cancer (m-CRPC) patients who have progressed/drug resistant following prior standard care trea...
What is the current status of trial NCT04060394?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2019-09-13. Estimated completion is 2024-03-30.
What interventions are being tested in trial NCT04060394?
The interventions under investigation include: Phase I and Phase II: LAE001/prednisone + afuresertib (DRUG).
Who is sponsoring clinical trial NCT04060394?
This trial is sponsored by Laekna Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04060394's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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