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NCT02144051 · ClinicalTrials.gov registry record · Phase 1
Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors
A Phase 1 study of Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 4
- Study locations
NCT02144051: Completed Phase 1 study of Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor, sponsored by AstraZeneca.
NCT02144051 is a Phase 1 study of Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor that has completed, run by AstraZeneca. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02144051, a Phase 1 study of Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose, Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a multicentre study with sites in the United States and United Kingdom. Approximately 90 patients are expected to be enrolled in this study. The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.
Primary Outcome
The patient population used for determination of the MTD will consist of patients who have met the minimum safety evaluation requirements of the study, and/or who have experienced a DLT. Minimum safety requirements will be met if, during Cycle 1 of treatment, the patient receives all doses of AZD5312, completes all required safety evaluations, and is observed for at least 28 days following the first dose of AZD5312.
Conditions Studied
Interventions
- DRUG AZD5312
Study Locations (4)
Florida
- Research Site - Sarasota
Tennessee
- Research Site - Nashville
Wisconsin
- Research Site - Milwaukee
Other
- Research Site - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-05 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT02144051 record still lists
NCT02144051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor appearing as the primary indexed condition, and to 1 intervention - of which AZD5312 is the first listed.
NCT02144051 reports a single indexed study location in Florida, Tennessee, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02144051 about?
NCT02144051 is a clinical study titled "Phase I Open Label Dose Escalation Study to Investigate the Safety & Pharmacokinetics of AZD5312 in Patients With Androgen Receptor Tumors". This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose, Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a multicentre study with sites in the United States and United Kingdom. Approximately 90 patients are expected to be enro...
What is the current status of trial NCT02144051?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2014-05. Estimated completion is 2016-03.
What conditions does trial NCT02144051 study?
This clinical trial studies the following conditions: Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor.
What interventions are being tested in trial NCT02144051?
The interventions under investigation include: AZD5312 (DRUG).
Who is sponsoring clinical trial NCT02144051?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02144051 being conducted?
This trial has 4 study locations across Florida, Tennessee, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02144051's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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