NCT01202591

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

A Randomised Double-blind Phase IIa Study (With Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients With FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment With Prior Endocrine Therapy (Adjuvant or First-line Metastatic) (GLOW)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)

Conditions

• FGFR Inhibition, Pharmacokinetics, Biomarkers
• ER+ Breast Cancer

Interventions

Type	Name	Description
DRUG	AZD4547	Tablet oral twice daily
DRUG	Exemestane	Tablet oral once daily
DRUG	Placebo	Tablet oral twice daily
DRUG	Fulvestrant	A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2010-09-16
• Last updated: 2016-02-11
• Results posted: 2016-02-11

Locations

21 sites across 8 countries: Belgium, Czechia, France, Germany, Hungary, Italy, Romania, United Kingdom