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AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer

NCT ID: NCT01597388

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-08

Study Completion Date

2028-09-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Metastatic Breast Cancer

Keywords

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Estrogen receptor positive Advanced metastatic breast cancer Estrogen receptor positive advanced metastatic breast cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AZD2014 with Fulvestrant

AZD2014 with Fulvestrant

Group Type EXPERIMENTAL

AZD2014

Intervention Type DRUG

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

Fulvestrant

Intervention Type DRUG

IM monthly after loading dose

Interventions

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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

Intervention Type DRUG

Fulvestrant

IM monthly after loading dose

Intervention Type DRUG

Other Intervention Names

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faslodex

Eligibility Criteria

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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.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Sarasota, Florida, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Research Site

Oklahoma City, Oklahoma, United States

Site Status

Research Site

Greenville, South Carolina, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.emergingmed.com/networks/AstraZeneca

AstraZeneca Cancer Study Locator Service http://www.emergingmed.com/networks/AstraZeneca [email protected] 1-877-400-4656

Other Identifiers

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BRE-196

Identifier Type: -

Identifier Source: secondary_id

264477

Identifier Type: OTHER

Identifier Source: secondary_id

D2270C00005

Identifier Type: -

Identifier Source: org_study_id