Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients (GLOW)
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ClinicalTrials.gov Identifier: NCT01202591 |
Recruitment Status :
Completed
First Posted : September 16, 2010
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
FGFR Inhibition, Pharmacokinetics, Biomarkers ER+ Breast Cancer | Drug: AZD4547 Drug: Exemestane Drug: Placebo Drug: Fulvestrant | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 127 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious) [ Time Frame: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up). ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202591
Belgium | |
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Leuven, Belgium | |
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Namur, Belgium | |
Czech Republic | |
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Brno, Czech Republic | |
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Praha 4, Czech Republic | |
France | |
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Villejuif Cedex, France | |
Germany | |
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Erlangen, Germany | |
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München, Germany | |
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Rostock, Germany | |
Hungary | |
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Budapest, Hungary | |
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Kaposvár, Hungary | |
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Nyíregyháza, Hungary | |
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Szeged, Hungary | |
Italy | |
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Genova, Italy | |
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Lido di Camaiore, Italy | |
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Roma, Italy | |
Romania | |
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Cluj Napoca, Romania | |
United Kingdom | |
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Dundee, United Kingdom | |
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London, United Kingdom | |
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Manchester, United Kingdom | |
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Oxford, United Kingdom | |
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Sutton, United Kingdom |
Study Director: | Donal Landers | AstraZeneca |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01202591 |
Other Study ID Numbers: |
D2610C00003 2010-021220-10 ( EudraCT Number ) |
First Posted: | September 16, 2010 Key Record Dates |
Results First Posted: | February 11, 2016 |
Last Update Posted: | February 11, 2016 |
Last Verified: | January 2016 |
Breast Cancer ER+ FGFR1 |
Exemestane AZD4547 Fulvestrant |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Exemestane Antineoplastic Agents, Hormonal Antineoplastic Agents |
Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |