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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01597388




Registration number
NCT01597388
Ethics application status
Date submitted
28/03/2012
Date registered
14/05/2012
Date last updated
1/10/2024

Titles & IDs
Public title
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
Scientific title
A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer
Secondary ID [1] 0 0
BRE-196
Secondary ID [2] 0 0
D2270C00005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD2014
Treatment: Drugs - Fulvestrant

Experimental: AZD2014 with Fulvestrant - AZD2014 with Fulvestrant


Treatment: Drugs: AZD2014
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

Treatment: Drugs: Fulvestrant
IM monthly after loading dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
Up to 12 Months
Primary outcome [2] 0 0
Adverse Events Leading to Dose Reduction of AZD2014
Timepoint [2] 0 0
Up to 28 Days
Primary outcome [3] 0 0
Clinically Important Changes in Haematology Parameters
Timepoint [3] 0 0
Up to 12 Months
Primary outcome [4] 0 0
Clinically Important Changes in Clinical Chemistry Parameters
Timepoint [4] 0 0
Up to 12 Months
Primary outcome [5] 0 0
Left Ventricular Ejection Fraction
Timepoint [5] 0 0
24 hours
Primary outcome [6] 0 0
QTcF Over 24 Hours
Timepoint [6] 0 0
24 hours
Primary outcome [7] 0 0
Post-Baseline Glucose Elevation
Timepoint [7] 0 0
28 Days
Primary outcome [8] 0 0
Sitting Diastolic Blood Pressure
Timepoint [8] 0 0
28 Days
Primary outcome [9] 0 0
Sitting Systolic Blood Pressure
Timepoint [9] 0 0
28 Days
Primary outcome [10] 0 0
Respiratory Rate
Timepoint [10] 0 0
28 Days
Primary outcome [11] 0 0
Heart Rate
Timepoint [11] 0 0
28 Days
Primary outcome [12] 0 0
Body Temperature
Timepoint [12] 0 0
28 Days
Primary outcome [13] 0 0
Oxygen Saturation
Timepoint [13] 0 0
28 Days
Primary outcome [14] 0 0
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Timepoint [14] 0 0
5 Days
Primary outcome [15] 0 0
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Timepoint [15] 0 0
5 Days
Primary outcome [16] 0 0
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Timepoint [16] 0 0
5 Days
Primary outcome [17] 0 0
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Timepoint [17] 0 0
5 Days
Primary outcome [18] 0 0
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-8) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Timepoint [18] 0 0
5 Days
Primary outcome [19] 0 0
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
Timepoint [19] 0 0
15 Days
Primary outcome [20] 0 0
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
Timepoint [20] 0 0
15 Days
Primary outcome [21] 0 0
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant
Timepoint [21] 0 0
15 Days
Primary outcome [22] 0 0
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Timepoint [22] 0 0
22 Days
Primary outcome [23] 0 0
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Timepoint [23] 0 0
22 Days
Primary outcome [24] 0 0
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant
Timepoint [24] 0 0
15 Days
Secondary outcome [1] 0 0
AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
Timepoint [1] 0 0
1 Day
Secondary outcome [2] 0 0
Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.
Timepoint [2] 0 0
1 Day
Secondary outcome [3] 0 0
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.
Timepoint [3] 0 0
1 Day
Secondary outcome [4] 0 0
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-8) Following Single Dose, Fasted, no Fulvestrant.
Timepoint [4] 0 0
1 Day
Secondary outcome [5] 0 0
Objective Response Rate
Timepoint [5] 0 0
Up to 12 months
Secondary outcome [6] 0 0
Best Objective Response (BOR)
Timepoint [6] 0 0
Up to 12 months
Secondary outcome [7] 0 0
Duration of Response (DoR)
Timepoint [7] 0 0
Up to 12 months
Secondary outcome [8] 0 0
Clinical Benefit Rate (CBR) at 24 Weeks
Timepoint [8] 0 0
Up to 12 months
Secondary outcome [9] 0 0
Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.
Timepoint [9] 0 0
Up to 12 months
Secondary outcome [10] 0 0
Progression Free Survival
Timepoint [10] 0 0
Up to 12 months
Secondary outcome [11] 0 0
Progression Free Survival at 26 Weeks
Timepoint [11] 0 0
Up to 12 months

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
100 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/09/2028
Actual
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
South Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01597388