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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 is a Phase 1 study that has completed, run by Laekna Limited. The registered enrollment target is 49 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04060394
The ClinicalTrials.gov registry entry for NCT04060394 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laekna Limited, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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