Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC
Public ClinicalTrials.gov record NCT04060394. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04060394
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 49 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2019 (Actual)
- Primary completion
- Dec 27, 2023 (Actual)
- Completion
- Mar 30, 2024 (Actual)
- Last update posted
- Oct 10, 2024
2019 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urological Associates of Southern Arizona | Tucson | Arizona | 85741 | — |
| California Cancer Associates for Researh & Excellence, Inc | Encinitas | California | 92024 | — |
| Eastern Connnecticut Hematology/Oncology Associates | Norwich | Connecticut | 06360 | — |
| Piedmont Columbus Regional Research Institute | Columbus | Georgia | 31901 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Cotton-O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Associated Medical Professionals of NY | Syracuse | New York | 13215 | — |
| Oregon Urology Institute | Florence | Oregon | 97439 | — |
| Greenville Hospital System | Greenville | South Carolina | 29605 | — |
| Mary Crowley Cancer Research Centers | Dallas | Texas | 75251 | — |
| Baylor Scott and White Health | Temple | Texas | 76508 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04060394, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 10, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04060394 live on ClinicalTrials.gov.