AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01597388
First received: March 28, 2012
Last updated: September 10, 2014
Last verified: September 2014

March 28, 2012
September 10, 2014
May 2012
December 2014   (final data collection date for primary 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. [ Time Frame: From screening until the end of the follow up period, an expected average of 6 months ] [ Designated as safety issue: Yes ]
  • Determination of the steady state PK profile of AZD2014 in combination with fulvestrant by assessment including:maximum plasma concentration of AZD2014 at steady state(Css,max),time to Css,max and area under the plasma concentration-time curve (AUCss). [ Time Frame: At multiple time-points on Day 22 of multiple dosing ] [ Designated as safety issue: No ]
  • To assess 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. [ Time Frame: From screening until the end of the follow up period, an expected average of 6 months ] [ Designated as safety issue: Yes ]
  • To determine the steady state PK profile of AZD2014 in combination with fulvestrant by assessment including:maximum plasma concentration of AZD2014 at steady state(Css,max),time to Css,max and area under the plasma concentration-time curve (AUCss). [ Time Frame: At multiple time-points on Day 22 of multiple dosing ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01597388 on ClinicalTrials.gov Archive Site
  • Determination of the minimum plasma concentration at steady state of fulvestrant when administered in combination with AZD2014. [ Time Frame: Samples will be obtained on Day 29 and Day 57 of multiple dosing ] [ Designated as safety issue: No ]
  • Determination of the single dose PK profile of AZD2014,by assessments including: maximum plasma concentration (Cmax),time to Cmax,terminal rate constant half life,area under the plasma concentration-time curve (AUC0-12 and AUC0-24). [ Time Frame: At multiple time-points on the day of single dosing. This will be up to 5 days prior to the start of multiple dosing. ] [ Designated as safety issue: No ]
  • To determine the minimum plasma concentration at steady state of fulvestrant when administered in combination with AZD2014. [ Time Frame: Samples will be obtained on Day 29 and Day 57 of multiple dosing ] [ Designated as safety issue: No ]
  • To determine the single dose PK profile of AZD2014,by assessments including: maximum plasma concentration (Cmax),time to Cmax,terminal rate constant half life,area under the plasma concentration-time curve (AUC0-12 and AUC0-24). [ Time Frame: At multiple time-points on the day of single dosing. This will be up to 5 days prior to the start of multiple dosing. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
AZD2014 and Fulvestrant in Patients With 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

The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Advanced Metastatic Breast Cancer
  • Drug: AZD2014
    Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week
  • Drug: Fulvestrant
    IM monthly after loading dose
    Other Name: faslodex
Experimental: AZD2014 with Fulvestrant
AZD2014 with Fulvestrant
Interventions:
  • Drug: AZD2014
  • Drug: Fulvestrant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
February 2015
December 2014   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact: AstraZeneca Clinical Study Information 800-236-9933 ClinicalTrialTransparency@astrazeneca.com
Contact: ASKSARAH Dedicated Service for our Patients and Research Sites 1-877-MY-1-SCRI (691-7274)
United States
 
NCT01597388
D2270C00005, BRE-196
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Howard Burris, MD SCRI Development Innovations, LLC
AstraZeneca
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP