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

AstraZeneca

Status and phase

Active, not recruiting

Phase 1

Conditions

Advanced Metastatic Breast Cancer

Treatments

Drug: AZD2014

Drug: Fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01597388

264477 (Other Identifier)

D2270C00005

BRE-196

Details and patient eligibility

About

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

Full 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.

Enrollment

99 patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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)