Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
GLOW
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)
2 other identifiers
interventional
127
8 countries
21
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2010
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
February 11, 2016
CompletedFebruary 11, 2016
January 1, 2016
3.8 years
September 14, 2010
September 7, 2015
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)
3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).
Study Arms (3)
AZD4547 + exemestane
EXPERIMENTALSafety run-in: AZD4547 plus exemestane
AZD4547 + fulvestrant
EXPERIMENTALA Randomised phase IIa: AZD4547 plus fulvestrant
Placebo + fulvestrant
PLACEBO COMPARATORRandomised phase IIa: Matching placebo plus fulvestrant
Interventions
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Leuven, Belgium
Research Site
Namur, Belgium
Research Site
Brno, Czechia
Research Site
Prague, Czechia
Research Site
Villejuif, France
Research Site
Erlangen, Germany
Research Site
München, Germany
Research Site
Rostock, Germany
Research Site
Budapest, Hungary
Research Site
Kaposvár, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Szeged, Hungary
Research Site
Genova, Italy
Research Site
Lido di Camaiore, Italy
Research Site
Roma, Italy
Research Site
Cluj-Napoca, Romania
Research Site
Dundee, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Oxford, United Kingdom
Research Site
Sutton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrolment to the Part B was terminated on 27 March 2014. Slow recruitment led to concerns that enrolment would not be completed in a realistic timeframe. This led to a business decision to terminate the enrolment.
Results Point of Contact
- Title
- Richard Mather
- Organization
- Astrazeneca
Study Officials
- STUDY DIRECTOR
Donal Landers
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2010
First Posted
September 16, 2010
Study Start
December 1, 2010
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
February 11, 2016
Results First Posted
February 11, 2016
Record last verified: 2016-01