Overview

This trial is active, not recruiting.

Condition advanced metastatic breast cancer
Treatments azd2014, fulvestrant
Phase phase 1
Target mTOR
Sponsor AstraZeneca
Start date May 2012
End date August 2016
Trial size 110 participants
Trial identifier NCT01597388, BRE-196, D2270C00005

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
AZD2014 with Fulvestrant
azd2014
Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week, or twice daily dosing on the first and fourth day of the week
fulvestrant faslodex
IM monthly after loading dose

Primary Outcomes

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
Determination of the steady state/multiple dose PK profile of AZD2014 in combination with fulvestrant by assessments including:maximum plasma concentration of AZD2014 (Cmax),time to Cmax and area under the plasma concentration-time curve (AUC).
time frame: At multiple time-points on Day 22 of multiple continuous dosing, Day 23 of intermittent Day 1 and 2 dosing or the fourth day of intermittent Day 1 and 4 dosing

Secondary Outcomes

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
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.
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

Eligibility Criteria

Female participants from 18 years up to 100 years old.

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)

Additional Information

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
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 information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.