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)

AstraZeneca1 site in 1 country127 target enrollmentDecember 2010

ConditionsFGFR Inhibition, Pharmacokinetics, Biomarkers ER+ Breast Cancer

InterventionsAZD4547 Exemestane Fulvestrant Placebo

DrugsAZD4547 Exemestane Placebo Fulvestrant

Overview

Phase: Phase 1
Intervention: AZD4547
Conditions: FGFR Inhibition, Pharmacokinetics, Biomarkers
Sponsor: AstraZeneca
Enrollment: 127
Locations: 1
Primary Endpoint: Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

October 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
•Histological confirmation of Breast Cancer with documented ER+ receptor status
•Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
•Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
•Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits

Exclusion Criteria

•Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.
•More than 1 prior regimen of chemotherapy for breast cancer
•ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
•History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
•Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks