AZD2014 and Fulvestrant in patients with ER+ Advanced Metastatic Breast Cancer
Study identifier:D2270C00005
ClinicalTrials.gov identifier:NCT01597388
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official 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
Medical condition
Advanced Metastatic Breast Cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD2014, Fulvestrant
Sex
Female
Actual Enrollment
99
Study type
Interventional
Age
18 Years - 100 Years
Date
Study Start Date: 08 May 2012
Primary Completion Date: 04 Aug 2016
Estimated Study Completion Date: 05 Sept 2028
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD2014 with Fulvestrant AZD2014 with Fulvestrant | Drug: 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 Drug: Fulvestrant IM monthly after loading dose Other Name: faslodex |
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