NCT01597388

Brief Summary

The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2012

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 17, 2018

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

March 28, 2012

Results QC Date

September 18, 2017

Last Update Submit

February 6, 2026

Conditions

Advanced Metastatic Breast Cancer

Keywords

Estrogen receptor positiveAdvanced metastatic breast cancerEstrogen receptor positive advanced metastatic breast cancer

Outcome Measures

Primary Outcomes (24)

  • Adverse Events

    Up to 12 Months

  • Adverse Events Leading to Dose Reduction of AZD2014

    Up to 28 Days

  • Clinically Important Changes in Haematology Parameters

    Up to 12 Months

  • Clinically Important Changes in Clinical Chemistry Parameters

    Up to 12 Months

  • Left Ventricular Ejection Fraction

    24 hours

  • QTcF Over 24 Hours

    24 hours

  • Post-Baseline Glucose Elevation

    28 Days

  • Sitting Diastolic Blood Pressure

    28 Days

  • Sitting Systolic Blood Pressure

    28 Days

  • Respiratory Rate

    28 Days

  • Heart Rate

    28 Days

  • Body Temperature

    28 Days

  • Oxygen Saturation

    28 Days

  • AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    5 Days

  • AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    5 Days

  • AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    5 Days

  • AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    5 Days

  • AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    5 Days

  • AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant

    15 Days

  • Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant

    15 Days

  • AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant

    15 Days

  • AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant

    22 Days

  • Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant

    22 Days

  • AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant

    15 Days

Secondary Outcomes (11)

  • AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.

    1 Day

  • Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.

    1 Day

  • Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.

    1 Day

  • Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.

    1 Day

  • Objective Response Rate

    Up to 12 months

  • +6 more secondary outcomes

Study Arms (1)

AZD2014 with Fulvestrant

EXPERIMENTAL

AZD2014 with Fulvestrant

Drug: AZD2014Drug: Fulvestrant

Interventions

AZD2014DRUG

Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week, or twice daily dosing on the first and fourth day of the week

AZD2014 with Fulvestrant
FulvestrantDRUG

IM monthly after loading dose

Also known as: faslodex
AZD2014 with Fulvestrant

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis
  • Aged at least 18
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
  • Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients must have evidence of non-child-bearing potential.

You may not qualify if:

  • Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites)
  • Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study.
  • Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.
  • Patients with diabetes type 1 or uncontrolled type II (HbA1c \> 8% assessed locally)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Sarasota, Florida, 34232, United States

Location

Research Site

Detroit, Michigan, 48201, United States

Location

Research Site

Oklahoma City, Oklahoma, 73104, United States

Location

Research Site

Greenville, South Carolina, 29605, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Related Links

MeSH Terms

Interventions

vistusertibFulvestrant

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Julie Charlton
Organization
AstraZeneca
ClinicalTrialTransparancy@astrazeneca.com
+ 01625-582828

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

May 14, 2012

Study Start

May 8, 2012

Primary Completion

August 4, 2016

Study Completion

January 13, 2026

Last Updated

February 24, 2026

Results First Posted

October 17, 2018

Record last verified: 2026-02

Locations

US(5)