Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients (GLOW)

January 13, 2016 updated by: AstraZeneca

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • Research Site
      • Namur, Belgium
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
  • France
      • Villejuif Cedex, France
        • Research Site
  • Germany
      • Erlangen, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Kaposvár, Hungary
        • Research Site
      • Nyíregyháza, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
  • Italy
      • Genova, Italy
        • Research Site
      • Lido di Camaiore, Italy
        • Research Site
      • Roma, Italy
        • Research Site
  • Romania
      • Cluj Napoca, Romania
        • Research Site
  • United Kingdom
      • Dundee, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site
      • Sutton, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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: Fulvestrant
A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
Drug: Placebo
Tablet oral twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Donal Landers, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2610C00003
  • 2010-021220-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on FGFR Inhibition, Pharmacokinetics, Biomarkers

Clinical Trials on AZD4547

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe