Study identifier:D2270C00005
ClinicalTrials.gov identifier:NCT01597388
EudraCT identifier:N/A
CTIS identifier:N/A
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
Advanced Metastatic Breast Cancer
Phase 1
No
AZD2014, Fulvestrant
Female
99
Interventional
18 Years - 100 Years
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant
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.
Location
Location
Oklahoma City, OK, United States, 73104
Location
Nashville, TN, United States, 37203
Location
Sarasota, FL, United States, 34232
Location
Greenville, SC, United States, 29605
Location
Detroit, MI, United States, 48201
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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