Description:
The purpose of this study is to assess safety and tolerability of AZD2014 when given in
combination with Fulvestrant.
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
Drug | Synonyms | Arms |
---|
AZD2014 | | AZD2014 with Fulvestrant |
Fulvestrant | faslodex | AZD2014 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
Name | Type | Description | Interventions |
---|
AZD2014 with Fulvestrant | Experimental | AZD2014 with 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