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)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Safety Run-in: Safety and tolerability in terms of number of patients with Adverse events (serious and non-serious)
Adverse events recorded from patient screening to discontinuation from study plus 28 days safety follow-up
Yes
Paul Stockman
Study Director
AstraZeneca
Belgium: Federal Agency for Medicinal Products and Health Products
D2610C00003
NCT01202591
December 2010
March 2015
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