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NCT03310541 · ClinicalTrials.gov registry record · Phase 1
AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03310541: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03310541 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03310541, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study will test the recommended dose of AZD5363 (recommended from a previous phase 1 study of the drug) in patients with specific AKT mutations. In patients who have ER positive breast cancer with an AKT mutation, they will also be receiving a standard breast cancer drug called fulvestrant that is given as an injection. In patients who have prostate cancer with an AKT mutation, they will also be receiving a standard prostate cancer drug called enzalutamide that is taken orally.
Primary Outcome
A response is defined as any of the following: a response according to RECIST v 1.1, PCWG3 (for patients with measurable visceral and/or nodal disease at baseline) or RANO as applicable or a reduction in the PSA level of 50% or more (for prostate cancer patients without visceral and/or nodal disease at baseline), with a confirmatory assessment at least 4 weeks later.
Interventions
- DRUG Fulvestrant
- DRUG Enzalutamide
- DRUG AZD5363
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2023-05-03 |
| Phase | Phase 1 |
What the finished NCT03310541 record still lists
NCT03310541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT03310541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03310541 about?
NCT03310541 is a clinical study titled "AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations". This study will test the recommended dose of AZD5363 (recommended from a previous phase 1 study of the drug) in patients with specific AKT mutations. In patients who have ER positive breast cancer with an AKT mutation, they will also be receiving a standard breast cancer drug called fulvestrant that...
What is the current status of trial NCT03310541?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-10-11. Estimated completion is 2023-05-03.
What interventions are being tested in trial NCT03310541?
The interventions under investigation include: Fulvestrant (DRUG), Enzalutamide (DRUG), AZD5363 (DRUG).
Who is sponsoring clinical trial NCT03310541?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03310541's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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