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
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
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Assessment of safety and tolerability of AZD2014, when given in combination with fulvestrant, by assessment of: adverse events, clinical chemistry and haematology laboratory parameters, ECG data, vital signs and physical examination.
From screening until the end of the follow up period, an expected average of 6 months
Yes
Howard Burris, MD
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
D2270C00005
NCT01597388
May 2012
November 2013
Name | Location |
---|---|
Research Site | Boca Raton, Florida |
Research Site | Battle Kreek, Michigan |
Research Site | Charleston, South Carolina |
Research Site | Chattanooga, Tennessee |