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A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Advanced Metastatic Breast Cancer

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Trial Information

A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer


A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability,
Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination with
Intramuscular (IM) Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced,
Metastatic Breast Cancer


Inclusion Criteria:



- Provision of signed and dated written informed consent prior to any study specific
procedures, sampling analysis

- Aged at least 18

- Histological or cytological confirmation of an ER+ advanced metastatic breast cancer
tumour that is eligible for treatment with fulvestrant

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Patients must have evidence of non-child-bearing potential.

Exclusion Criteria:

- Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide,
immunotherapy, other anticancer agents, and any investigational agents within 14 days
of starting study treatment (not including palliative radiotherapy at focal sites)

- Major surgery within 4 weeks prior to entry to the study (excluding placement of
vascular access), or minor surgery within 2 weeks of entry into the study.

- Patients with severe cardiac condition of ischemia, impaired ventricular function and
arrhythmias, evidence of severe or uncontrolled systemic or current unstable or
uncompensated respiratory or cardiac conditions.

- Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Assessment of safety and tolerability of AZD2014, when given in combination with fulvestrant, by assessment of: adverse events, clinical chemistry and haematology laboratory parameters, ECG data, vital signs and physical examination.

Outcome Time Frame:

From screening until the end of the follow up period, an expected average of 6 months

Safety Issue:

Yes

Principal Investigator

Howard Burris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

D2270C00005

NCT ID:

NCT01597388

Start Date:

May 2012

Completion Date:

November 2013

Related Keywords:

  • Advanced Metastatic Breast Cancer
  • Estrogen receptor positive
  • Advanced metastatic breast cancer
  • Estrogen receptor positive advanced metastatic breast cancer
  • Breast Neoplasms

Name

Location

Research SiteBoca Raton, Florida  
Research SiteBattle Kreek, Michigan  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee