Clinical Trials /

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

NCT01597388

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
  • Official Title: 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.

Clinical Trial IDs

  • ORG STUDY ID: D2270C00005
  • SECONDARY ID: BRE-196
  • NCT ID: NCT01597388

Conditions

  • Advanced Metastatic Breast Cancer

Interventions

DrugSynonymsArms
AZD2014AZD2014 with Fulvestrant
FulvestrantfaslodexAZD2014 with Fulvestrant

Purpose

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

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
AZD2014 with FulvestrantExperimentalAZD2014 with Fulvestrant
  • AZD2014
  • Fulvestrant

Eligibility Criteria

        Inclusion Criteria:

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

          -  Aged at least 18

          -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed
             at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain
             X-ray and is suitable for repeated assessment

          -  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)
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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: for continuous dosing, on the day of single dosing (up to 5 days prior to the start of multiple dosing); for Day 1 & 2 intermittent, on the first dose of week 3; for Day 1 & 4 intermittent, on the first day of dosing.
Safety Issue:
Description:
Measure:Obtain a preliminary assessment of the anti-tumour activity of AZD2014, when given in combination with fulvestrant, by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1)
Time Frame:At screening and every 8 weeks until progression, an expected average of 6 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Estrogen receptor positive
  • Advanced metastatic breast cancer
  • Estrogen receptor positive advanced metastatic breast cancer

Last Updated

July 25, 2017