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:Adverse Events
Time Frame:Up to 12 Months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
Time Frame:1 Day
Safety Issue:
Description:
Measure:Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.
Time Frame:1 Day
Safety Issue:
Description:
Measure:Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.
Time Frame:1 Day
Safety Issue:
Description:
Measure:Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.
Time Frame:1 Day
Safety Issue:
Description:
Measure:Objective Response Rate
Time Frame:Up to 12 months
Safety Issue:
Description:Objective Response Rate (ORR) is defined as the number (%) of patients with a confirmed overall response of either complete response (CR) or partial response (PR).
Measure:Best Objective Response (BOR)
Time Frame:Up to 12 months
Safety Issue:
Description:Best objective response was the best response a patient had following start of treatment but prior to starting any subsequent cancer therapy and prior to RECIST v1.1 progression or the last evaluable assessment in the absence of RECIST v1.1 progression.
Measure:Duration of Response (DoR)
Time Frame:Up to 12 months
Safety Issue:
Description:Duration of response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Measure:Clinical Benefit Rate (CBR) at 24 Weeks
Time Frame:Up to 12 months
Safety Issue:
Description:The Clinical Benefit Rate (CBR) at 24 weeks is defined as the percentage of patients who had a confirmed BOR of CR or PR in the first 24 weeks or who demonstrated SD for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e., 161 days) following the start of treatment.
Measure:Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.
Time Frame:Up to 12 months
Safety Issue:
Description:Baseline was defined as last evaluable assessment prior to starting treatment. Tumour size was the sum of the longest diameters of the target lesions. TLs are measurable tumour lesions.
Measure:Progression Free Survival
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Progression Free Survival at 26 Weeks
Time Frame:Up to 12 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 15, 2021