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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 59 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01692262
The ClinicalTrials.gov registry entry for NCT01692262 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intermittent dosing of AZD5363 is the first listed.
NCT01692262 reports 0 study locations.
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.
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