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NCT01226316 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 285
- Enrollment target
NCT01226316: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01226316 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 285 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (375% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01226316, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 285 participants
- Enrollment target
Study Summary
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.
Interventions
- DRUG AZD5363
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2010-12-01 |
| Est. Completion | 2024-12-03 |
| Phase | Phase 1 |
What the finished NCT01226316 record still lists
NCT01226316 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (375% higher).
The record links to 0 conditions, and to 1 intervention - of which AZD5363 is the first listed.
NCT01226316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01226316 about?
NCT01226316 is a clinical study titled "Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules". This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes...
What is the current status of trial NCT01226316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 285 participants. The study started on 2010-12-01. Estimated completion is 2024-12-03.
What interventions are being tested in trial NCT01226316?
The interventions under investigation include: AZD5363 (DRUG).
Who is sponsoring clinical trial NCT01226316?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01226316's enrollment target sits among peer trials
285 139th of 2000 higher than 1,862 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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