Study identifier:D2610C00003
ClinicalTrials.gov identifier:NCT01202591
EudraCT identifier:2010-021220-10
CTIS identifier:N/A
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)
FGFR inhibition, pharmacokinetics, biomarkers
Phase 1/2
No
AZD4547, Exemestane, Placebo, Fulvestrant
Female
127
Interventional
18 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2016 by AstraZeneca
AstraZeneca
-
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)
Location
Location
Leuven, Belgium
Location
Namur, Belgium
Location
Brno, Czech Republic
Location
Praha 4, Czech Republic
Location
Erlangen, Germany
Location
München, Germany
Location
Rostock, Germany
Location
VILLEJUIF CEDEX, France
Arms | Assigned Interventions |
---|---|
Experimental: AZD4547 + exemestane Safety run-in: AZD4547 plus exemestane | Drug: AZD4547 Tablet oral twice daily Drug: Exemestane Tablet oral once daily |
Experimental: AZD4547 + fulvestrant A Randomised phase IIa: AZD4547 plus fulvestrant | Drug: AZD4547 Tablet oral twice daily Drug: Fulvestrant A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration |
Placebo Comparator: Placebo + fulvestrant Randomised phase IIa: Matching placebo plus fulvestrant | 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 |
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