Status:
COMPLETED
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
Lead Sponsor:
AstraZeneca
Conditions:
FGFR Inhibition, Pharmacokinetics, Biomarkers
ER+ Breast Cancer
Eligibility:
FEMALE
18-99 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01202591
Start Date
December 1 2010
End Date
October 1 2014
Last Update
February 11 2016
Active Locations (21)
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1
Research Site
Leuven, Belgium
2
Research Site
Namur, Belgium
3
Research Site
Brno, Czechia
4
Research Site
Prague, Czechia