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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 is a Phase 1 study of Advanced and Metastatic Breast Cancer that has completed, run by AstraZeneca. The registered enrollment target is 54 participants. The trial reports 7 study locations across 6 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02599714
The ClinicalTrials.gov registry entry for NCT02599714 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 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 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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.
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