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NCT02248090 · ClinicalTrials.gov registry record · Phase 1
AZD9496 First Time in Patients Ascending Dose Study
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT02248090: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02248090 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02248090, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a phase 1 open label multicentre study of AZD9496 administered orally in patients with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic dose(s) in patients with or without ESR1 mutations will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of AZD9496
Primary Outcome
Safety and tolerability in terms of adverse events, serious adverse events (including death) and safety measures: ECG, physical examination, vital signs and laboratory variables. Definition of maximum tolerated dose (MTD) or maximum feasible dose (MFD) by measuring the number of evaluable patients with dose-limiting toxicities.Time frame DLT period 28 days
Interventions
- DRUG AZD9496
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-10-22 |
| Est. Completion | 2019-04-03 |
| Phase | Phase 1 |
What the finished NCT02248090 record still lists
NCT02248090 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which AZD9496 is the first listed.
NCT02248090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02248090 about?
NCT02248090 is a clinical study titled "AZD9496 First Time in Patients Ascending Dose Study". This is a phase 1 open label multicentre study of AZD9496 administered orally in patients with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dos...
What is the current status of trial NCT02248090?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-10-22. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT02248090?
The interventions under investigation include: AZD9496 (DRUG).
Who is sponsoring clinical trial NCT02248090?
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 NCT02248090's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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