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NCT02599714 · ClinicalTrials.gov registry record · Phase 1
Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
A Phase 1 study of Advanced and Metastatic Breast Cancer, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 7
- Study locations
NCT02599714: Completed Phase 1 study of Advanced and Metastatic Breast Cancer, sponsored by AstraZeneca.
NCT02599714 is a Phase 1 study of Advanced and Metastatic Breast Cancer that has completed, run by AstraZeneca. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02599714, a Phase 1 study of Advanced and Metastatic Breast Cancer, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 7
- Study locations
Study Summary
This dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/ metastatic estrogen receptor positive (ER+) breast cancer. Part B was to further characterize safety, tolerability, PK, and preliminary efficacy in single-arm dose expansion groups. Part C was to be a Phase 2, randomized, double-blind, extension comparing the triplet and doublet combinations. Part C was deleted from the protocol and was not performed.
Primary Outcome
Safety and tolerability assessed through the incidence of adverse events.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG AZD2014
Study Locations (7)
Other
- Research Site - Liverpool
- Research Site - London
California
- Research Site - Encinitas
Florida
- Research Site - Sarasota
Michigan
- Research Site - Detroit
Tennessee
- Research Site - Nashville
Wisconsin
- Research Site - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2015-12-07 |
| Est. Completion | 2023-11-23 |
| Phase | Phase 1 |
What the finished NCT02599714 record still lists
NCT02599714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Advanced and Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fulvestrant is the first listed.
NCT02599714 lists 7 locations in 6 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT02599714 about?
NCT02599714 is a clinical study titled "Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer". This dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/ metastatic estrogen receptor...
What is the current status of trial NCT02599714?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2015-12-07. Estimated completion is 2023-11-23.
What conditions does trial NCT02599714 study?
This clinical trial studies the following conditions: Advanced and Metastatic Breast Cancer.
What interventions are being tested in trial NCT02599714?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), AZD2014 (DRUG).
Who is sponsoring clinical trial NCT02599714?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02599714 being conducted?
This trial has 7 study locations across California, Florida, Michigan, 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 NCT02599714's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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