Know Cancer

or
forgot password

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)


Phase 1/Phase 2
N/A
N/A
Open (Enrolling)
Female
FGFR Inhibition, Pharmacokinetics, Biomarkers, ER+ Breast Cancer

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Safety Run-in: Safety and tolerability in terms of number of patients with Adverse events (serious and non-serious)

Outcome Time Frame:

Adverse events recorded from patient screening to discontinuation from study plus 28 days safety follow-up

Safety Issue:

Yes

Principal Investigator

Paul Stockman

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

D2610C00003

NCT ID:

NCT01202591

Start Date:

December 2010

Completion Date:

March 2015

Related Keywords:

  • FGFR Inhibition, Pharmacokinetics, Biomarkers
  • ER+ Breast Cancer
  • Breast Cancer
  • ER+
  • FGFR1
  • Exemestane
  • AZD4547
  • Fulvestrant
  • Breast Neoplasms

Name

Location