At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
AZD4547 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating AZD4547, Exemestane, and 2 other interventions for FGFR Inhibition, Pharmacokinetics, Biomarkers and ER+ Breast Cancer. Completed, enrolled 127 participants across 21 sites in 8 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, France, Germany, Hungary, Italy, Romania, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartDec 2010
Primary CompletionSep 2014
Study CompletionOct 2014
TodayJul 2026
First PostedSep 16, 2010
Enrollment StartDec 1, 2010
Primary CompletionSep 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.8 years ago
Interventions
AZD4547drug
Tablet oral twice daily
Exemestanedrug
Tablet oral once daily
Placebodrug
Tablet oral twice daily
Fulvestrantdrug
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration