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NCT01692262 · ClinicalTrials.gov registry record · Phase 1
Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT01692262: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01692262 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01692262, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy, in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated in patients who have progressed after chemotherapy (Part A) and in patients who have progressed before receiving chemotherapy (Part B). Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off). Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients on a dose and schedule selected from Part A.
Interventions
- DRUG Intermittent dosing of AZD5363
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01692262 record still lists
NCT01692262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Intermittent dosing of AZD5363 is the first listed.
NCT01692262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01692262 about?
NCT01692262 is a clinical study titled "Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.". To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy, in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated in patients who have progressed after chemotherapy (Part A) and in patients who have progressed before receiving c...
What is the current status of trial NCT01692262?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2012-11. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01692262?
The interventions under investigation include: Intermittent dosing of AZD5363 (DRUG).
Who is sponsoring clinical trial NCT01692262?
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 NCT01692262's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 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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