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mTOR Kinase Inhibitor

AZD2014 + Fulvestrant for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is testing a new drug, AZD2014, to see if it is safe to take with Fulvestrant, and how well it is tolerated.

Who is the study for?
This trial is for adults over 18 with ER+ advanced metastatic breast cancer, who can provide consent and have at least one lesion visible on scans. They must be in good physical condition (ECOG 0 or 1) and not able to bear children. Excluded are those who've had recent cancer treatments, severe heart conditions, major surgery within the last month, minor surgery within two weeks, or uncontrolled type I or II diabetes.Check my eligibility
What is being tested?
The study tests the safety and tolerability of a drug combination: AZD2014 with Fulvestrant for treating ER+ advanced metastatic breast cancer. Participants will receive both medications to evaluate how well they work together.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar trials include nausea, fatigue, hormonal imbalances, potential blood clots due to Fulvestrant and possible organ-related issues from AZD2014.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one cancer lesion that can be measured by scans.
Select...
My breast cancer is ER+ and can be treated with fulvestrant.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant
+21 more
Secondary outcome measures
AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.
+8 more

Side effects data

From 2020 Phase 2 trial • 18 Patients • NCT02831257
89%
Nausea
83%
Diarrhea
72%
Hyphophosphatemia
67%
fatigue
56%
Abdominal pain
50%
Weight loss
39%
Anorexia
39%
mucositis
39%
Dry mouth
33%
Dysgeusia
33%
vomiting
28%
aspartate aminotransferase increased
22%
Constipation
17%
Hypertriglyceridemia
17%
High cholesterol
17%
infection
17%
Pruritis
17%
Rash, acneiform
11%
Headache
11%
Seizure
11%
anemia
6%
Heat stroke
6%
Pneumonia
6%
Psychosis
6%
Acute kidney injury
6%
Alanine aminotransferase increased
6%
tachycardia
6%
dyspepsia
6%
Creatine phosphokinase increased
6%
Dyspareunia
6%
Hematochezia
6%
Hyperuricemia
6%
malaise
6%
Difficulty chewing
6%
amenorrhea
6%
Urticaria
6%
vaginal pain
6%
white blood cells decreased
6%
Jaw weakness
6%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD2014

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZD2014 with FulvestrantExperimental Treatment2 Interventions
AZD2014 with Fulvestrant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2014
2015
Completed Phase 2
~1290
Fulvestrant
2011
Completed Phase 3
~3700

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,237 Previous Clinical Trials
288,449,576 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Howard Burris, MDStudy ChairSCRI Development Innovations, LLC
7 Previous Clinical Trials
316 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer

Media Library

AZD2014 (mTOR Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01597388 — Phase 1
Breast Cancer Research Study Groups: AZD2014 with Fulvestrant
Breast Cancer Clinical Trial 2023: AZD2014 Highlights & Side Effects. Trial Name: NCT01597388 — Phase 1
AZD2014 (mTOR Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01597388 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to partake in this experimental research?

"Eligible candidates who would like to participate in this medical trial must have breast cancer and be within the ages of 18 and 100. The clinical study is currently recruiting up to 99 patients."

Answered by AI

What primary maladies is AZD2014 employed to address?

"AZD2014, a commonly used endocrine therapy, is also beneficial when treating diseases such as breast cancer and the pik3ca gene mutation."

Answered by AI

Have there been other experiments with AZD2014 in the past?

"The AZD2014 drug was first studied 16 years ago at Lowell General Hospital. At present, there are 96 accomplished clinical trials and 140 in progress, many of which originate from Sarasota, Florida."

Answered by AI

Is it currently possible to enroll in this medical trial?

"As per the records on clinicaltrials.gov, this experiment is closed to new participants. Although initially posted in May 2012 and last edited October 2022, at present it does not need any additional candidates; however, there are 2427 other investigations currently open for recruitment."

Answered by AI

How many participants are being included in this experiment?

"Unfortunately, this trial is not taking participants currently. Initially appearing on the 5/8/2012 and lastly updated on 10/24/2022, if you are seeking alternate clinical trials, 2287 studies concerning breast cancer research are actively recruiting patients while 140 different investigations involving AZD2014 recruitment require test subjects."

Answered by AI

Has the Food and Drug Administration given their stamp of approval for AZD2014?

"The safety of AZD2014 was assessed by our team at Power and found to be a 1 on the scale due to its current status as a Phase 1 trial, which indicates limited efficacy and safety data."

Answered by AI

Is the age cutoff for this clinical experiment restricted to those under 25?

"This clinical trial only accepts patients between 18 and 100 years of age. However, there are additional 67 studies for minors aged under 18 as well as 2343 trials available to seniors over 65."

Answered by AI

Are several healthcare facilities conducting this experiment in the local area?

"At this moment, 5 clinical trial centres are running the study. These sites can be located in Sarasota, Detroit and Oklahoma City as well as a further five areas. To reduce travel stress when taking part in the trial it is best to select your closest location."

Answered by AI
~8 spots leftby Mar 2025